For other versions of this document, see http://wikileaks.org/wiki/CRS-RL32568 ------------------------------------------------------------------------------ Order Code RL32568 CRS Report for Congress Received through the CRS Web Senate Prescription Drug Importation Legislation: A Side-by-Side Comparison of Current Law, S. 2307, S. 2328, and S. 2493 September 7, 2004 Susan Thaul and Donna U. Vogt Specialists in Social Legislation Domestic Social Policy Division Congressional Research Service ~ The Library of Congress Senate Prescription Drug Importation Legislation: A Side-by-Side Comparison of Current Law, S. 2307, S. 2328, and S. 2493 Summary Senators Grassley, Dorgan, and Gregg have each introduced bills that address Congressional concerns with prescription drug importation that were not resolved by the provisions in the Medicare Prescription Drug, Improvement, and Modernization Act (the MMA, P.L. 108-173). ! S. 2307, the Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004, introduced by Senator Grassley on April 8, 2004 [the Grassley bill]; ! S. 2328, the Pharmaceutical Market Access and Drug Safety Act of 2004, introduced by Senator Dorgan on April 21, 2004 [the Dorgan bill]; and ! S. 2493, the Safe Importation of Medical Products and Other Rx Therapies Act of 2004, introduced by Senator Gregg on June 2, 2004 [the Gregg bill]. By continuing the major legal obstacle to importation -- the requirement that the Secretary of Health and Human Services first certify that imports are safe and offer cost savings to U.S. consumers, something no Secretary has been willing to do -- the MMA effectively does not allow the commercial or personal-use importation of prescription drugs. This report briefly discusses major differences among current law and the bills introduced in April and June 2004 and presents a side-by-side comparison of the provisions. Although all three bills seek to make lower-priced prescription drugs available to U.S. consumers by allowing importation while also ensuring that the drugs are safe and effective, they take different approaches. The three Senate bills use extensive registration, licensing, facility inspection, and records requirements to document an imported shipment's chain-of-custody requirements rather than the MMA's mandated laboratory testing of imported drugs to verify their content, potency, and labeling. Current law and the bills each have different lists of countries from which imports could be imported, and they provide the Secretary with different time frames and criteria for determining whether to permit commercial or personal-use importation. Secretarial reporting requirements vary as do mechanisms to fund the import activities: the MMA relies on appropriations, and the Senate bills each create specific user fee provisions. Only the Gregg bill requires the regulation of Internet pharmacies. The Grassley and Dorgan bills propose links to antitrust, patent, and internal revenue titles of the U.S. Code to influence industry behavior. The MMA does not specify when importation could begin. For commercial imports from Canada, the Grassley and Dorgan bills start 90 days from enactment, later for other countries; the Gregg bill allows imports from Canada only, beginning one year from enactment. The Grassley and Gregg bills allow personal-use imports from Canada upon enactment, with the Grassley bill's allowing other countries later; the Dorgan bill allows personal-use imports from Canada only, beginning 90 days after enactment. Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Differences Among the Bills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 FDA Approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Permitted Countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Logistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Incentives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Internet Pharmacies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Effective Dates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Side-by-Side Comparison . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Direction to regulate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Permitted countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Qualifying drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Relationship to FDA approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Monitoring and inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Records of chain of custody . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Charitable contributions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Repeal of controlled substances exemption . . . . . . . . . . . . . . . . . . . . . . . . . 18 Registration of importers and exporters . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Licensing as pharmacies and pharmacists . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Manufacturer requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Secretary's actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Studies and reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Enforcement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Personal use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Rulemaking deadlines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Effective dates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Appropriations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Protection against adulterated prescription drugs . . . . . . . . . . . . . . . . . . . . 55 Internet pharmacies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Prohibition of port shopping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Anti-counterfeiting programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 List of Tables Comparison of Prescription Drug Importation Provisions in Current Law, S. 2307, S. 2328, and S. 2493 . . . . . . . . . . . . . . . . . . . . . . . 6 Senate Prescription Drug Importation Legislation: A Side-by-Side Comparison of Current Law, S. 2307, S. 2328, and S. 2493 Introduction This report compares the provisions of three Senate prescription drug importation bills with current law provisions on the subject.1 The law on the importation of prescription drugs was recently amended by the Medicare Prescription Drug, Improvement, and Modernization Act (MMA, P.L. 108-173). The three bills2 with provisions compared to current law are: ! S. 2307, introduced by Senator Grassley on April 8, 2004 [the Grassley bill]; ! S. 2328, introduced by Senator Dorgan3 on April 21, 2004 [the Dorgan bill]; and ! S. 2493, introduced by Senator Gregg4 on June 2, 2004 [the Gregg bill]. The new law and the three bills all seek to balance the availability of imported prescription drugs -- both for commercial and personal use -- and the assurance that those imports would be safe and effective. The underlying goal is to reduce or restrain the growth of the financial burden that prescription drugs place on U.S. consumers. They all would act primarily by replacing or amending Section 804 of 1 This report replaces the CRS Congressional Distribution Memorandum, Senate Prescription Drug Importation Legislation [updated], by Susan Thaul and Donna U. Vogt, dated June 25, 2004. For a detailed comparison of changes in Section 804 made by the MMA to the preexisting law (as established by the 2000 MEDS Act), see CRS Report RL32271, Importation of Prescription Drugs Provisions in P.L. 108-173, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, by Susan Thaul and Donna U. Vogt. For an analysis of the issues involved in drug importation, see CRS Report RL32511, Importing Prescription Drugs: Objectives, Options, and Outlook, by Susan Thaul and Donna U. Vogt. 2 The House passed H.R. 2427 (introduced by Rep. Gil Gutknecht) on July 25, 2003, before passage of the MMA. The conferees did not, however, include its provisions in their final agreement. No Senate version was introduced. 3 Co-sponsors of S. 2328 at its introduction were Sens. Snowe, Kennedy, McCain, Daschle, Lott, Stabenow, Chafee, Johnson, Pryor, and Feingold; by Sept. 1, 2004, it had 30 co- sponsors. 4 Co-sponsors of S. 2493 at its introduction were Sens. Smith, Collins, Coleman, Sessions, Lott, and Enzi; by Sept. 1, 2004, Sen. Voinovich had joined as a co-sponsor. CRS-2 the Federal Food, Drug, and Cosmetic Act (FFDCA) that had been initially added to the FFDCA by the Medicine Equity and Drug Safety (MEDS) Act of 2000. Individual bills would amend other laws. Impetus for developing new importation legislation so soon after enactment of the MMA is the result of the new law's retaining the MEDS Act provision that importation not be allowed unless the Secretary of Health and Human Services (HHS) certifies that imports are safe and offer cost savings to U.S. consumers. The three bills each eliminate this requirement and, instead, include other potential safeguards regarding drug safety and effectiveness. Differences Among the Bills Some of the major areas of difference among the bills are the following: Monitoring While the MMA relies on laboratory testing of samples of every shipment of imported drugs to verify their content, potency, and labeling, the three proposed Senate bills focus on documentation of a monitored, uninterrupted chain of custody from manufacturing facility to importer. The MMA requires Canadian exporters to register with the Secretary. The Grassley and Dorgan bills specify extensive requirements for that registration, and the Dorgan bill extends similar registration requirements to importers as well as exporters. To do so, they require ongoing and onsite physical monitoring of the facilities of a drug's manufacturer, registered exporter, and registered importer, including inspection, if the Secretary determines it necessary, of any facility that handles the product along the chain of custody. The Gregg bill has extensive registration requirements for importers and dispensers of imported prescription drugs, including providing to the commercial purchaser identifying information on all preceding transactions that transferred the drug since it left the manufacturer's control. FDA Approval The MMA and the Gregg bill explicitly require that an imported drug be approved for U.S. sale by the Food and Drug Administration (FDA). The Grassley and Dorgan bills allow different administrative requirements for importation while maintaining the substantive elements of FDA approval. The Grassley bill also requires that the imported drug be manufactured in the same facility as the equivalent FDA-approved drug. CRS-3 Permitted Countries The three Senate bills5 and current law vary in the countries from which they would permit drug importation. The Grassley bill includes Australia, Canada, Japan, New Zealand, Switzerland, members of the European Union, Iceland, Liechtenstein, and Norway; it also allows the Secretary to designate additional countries that have equivalent regulatory requirements regarding safety and effectiveness. For commercial imports, the Dorgan bill differs in that it excludes Iceland, Liechtenstein, and Norway, and specifies European Union countries as of January 2003, thereby excluding the 10 admitted to membership in May 2004. The Dorgan bill, alone, distinguishes between commercial and personal-use imports regarding permitted countries, allowing only Canada for the latter. The Gregg bill includes Canada and allows the Secretary, three years after enactment, to designate as eligible any members of the European Union as of December 2003. Current law, the MMA, includes only Canada, although it allows the Secretary to grant waivers permitting personal-use importation from other countries. Logistics The Grassley bill would allow the manufacturer of an FDA-approved drug distributed in the United States to petition the Secretary to stop the importation of that drug when it has been manufactured in or exported to another country. The petition would have to assert that the imported drug differs from the U.S. drug enough that it would require a supplemental application to FDA if the manufacturer wanted to introduce it to the U.S. market. The manufacturer would, through fees similar to those established for supplemental applications under the Prescription Drug User Fee Act (PDUFA, P.L. 102-571), pay the expense of the Secretary's review. The Dorgan bill would require the manufacturer of any drug that "may be imported" to submit a notice with extensive documentation of the differences, if any, between a drug it produces for commercial marketing in a permitted country and the drug it produces for the U.S. market. Here, too, the manufacturer would pay for the review of these materials with fees similar to those required for supplemental or new drug applications under PDUFA. The Gregg bill does not require the manufacturer to document differences between its U.S.-marketed and foreign-marketed products. Reports The MMA and the Grassley bills require the HHS Secretary to submit reports to Congress. The MMA also requires a report from the Commerce Secretary and others. The Dorgan bill requires no report. The Gregg bill requires three reports to Congress, covering which countries the Secretary has designated as permitted for imports and the reasons why, the implementation of registration fees and the use of those fees, and the commissioning of federal and state officials to conduct inspections. 5 The most inclusive list is in H.R. 2427 [not included in this report's table], the Gutknecht bill, which follows the language in the MEDS Act of 2000. Permitted countries would be Australia, Canada, Israel, Japan, New Zealand, South Africa, Switzerland, members of the European Union, Iceland, Liechtenstein, and Norway. CRS-4 Funding The MMA includes no explicit funding mechanism other than authorizing appropriations of such sums as necessary to implement the provisions. The Grassley bill calls for exporter fees that, in the aggregate, would cover the cost of administering the import provisions. The Dorgan bill includes exporter and importer fees based on the share of volume of imports, adjusted annually, to not exceed 1% of the price of drug imports. The Gregg bill sets a $5,000 first-time registration fee and requires the Secretary to set annually a fee, based on anticipated costs, to enforce the Act without further appropriation. Incentives Implementation of the MMA is restricted by the requirement that the Secretary certify safety and cost savings. Criticism of the MMA cites anticipated manufacturer resistance. The Grassley and Dorgan bills propose links to antitrust, patent, and internal revenue titles of the U.S. Code to influence industry behavior. The Grassley bill includes tax incentives and penalties to minimize manufacturer interference. The Dorgan bill creates an antitrust provision to compel manufacturer participation and amends patent law to remove obstacles to importation. The Gregg bill includes neither positive nor negative incentives to influence manufacturer behavior. Internet Pharmacies Neither current law, the MMA, nor the Grassley and Dorgan bills, as introduced, address Internet sales.6 The Gregg bill presents an extensive statutory and regulatory structure for Internet pharmacies, placing it in the FFDCA, although set apart from the importation sections. In addition to registration, the bill requires that Internet pharmacies provide specific professional services including confidential patient medication profiles, "interactive and meaningful consultation by a licensed pharmacist," and verification of prescription validity. It requires advance notice of commercial shipments of prescription drug shipments and includes a licensing fee. Providers of interactive computer services are liable if they accept advertising for a prescription drug from an unlicensed Internet pharmacy or accept advertising stating a physician's prescription is not needed to obtain a prescription drug; the bill requires policies and procedures to prevent payments for unlawful Internet pharmacy requests. 6 Pending bills in the 108th Congress that address Internet pharmacies include H.R. 4598, H.R. 4612, H.R. 3880, H.R. 3870, H.R. 2652, H.R. 725, S. 2464, and S. 2288. The July 21, 2004 online newsletter, Inside Health Policy, reported that the Dorgan bill sponsors have added an Internet sales provision that covers U.S. Internet pharmacies. The report adds that the addition is based on a bill that Sens. Feinstein and Coleman introduced (S. 2464) as a companion bill to H.R. 3880, introduced by Reps. Davis and Waxman ("Dorgan Rx Import Bill Guards Against Fake U.S. Internet Pharmacies," July 21, 2004 at [http://insidehealthpolicy.com]. CRS-5 Effective Dates The MMA does not specify when importation could begin other than linking it to the required safety and cost certification by the Secretary. The three Senate bills stipulate various time frames for commercial and personal-use importation, with varying times for different countries. Commercial Imports. The Grassley bill requires that the Secretary promulgate and make effective an interim final rule not later than 90 days after enactment for commercial imports from Canada; it allows imports from other countries, approximately two years later, if the Secretary designates them based on a report required by the bill. The Dorgan bill would allow registered importers to import from Canada beginning when the Secretary promulgates an interim rule, which is required within 90 days of enactment; the Secretary could add other countries one year later. The Gregg bill would allow pharmacy and wholesaler importation from Canada one year after enactment, even if the Secretary has not issued regulations; the Secretary could allow imports from pre-2004 members of the European Union in three years, following a required study. Personal-Use Imports. The Grassley bill would allow a 90-day supply from Canada immediately until 45-days after promulgation of an interim final rule, which is required within 90 days of enactment. Following a report to Congress due 18 months after enactment, the Secretary may designate other countries from which to allow personal-use imports. The Dorgan bill allows personal-use imports from Canada beginning when the interim rule is promulgated, which is 90 days after enactment; it does not provide for personal-use imports from any other country. The Gregg bill allows personal-use imports from enactment, even if the Secretary has not issued regulations. It also requires the Secretary to promulgate interim final regulations regarding Internet pharmacy certification within one year of enactment, with licensing to take effect 90 days after that promulgation. Side-by-Side Comparison The following table arrays the prescription drug importation provisions of current law and the three Senate bills, with the columns ordered chronologically based on date of enactment or introduction. Organized by topic, the rows do not directly follow the order of provisions in any one of the compared documents. CRS-6 Comparison of Prescription Drug Importation Provisions in Current Law, S. 2307, S. 2328, and S. 2493 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 Legislation Section 804 of the Federal Food, Section 2. Repeals Section 804 of the Section 3. Repeals Section 804 of the Section 2. Adds a new Subchapter B Drug, and Cosmetic Act -- Federal Food, Drug, and Cosmetic Federal Food, Drug, and Cosmetic -- "Importation of Prescription Importation of Covered Products -- Act (FFDCA) as amended by Section Act (FFDCA) as amended by Section Drugs" -- to Chapter VIII of the was first established under the 1121(a) of P.L. 108-173. 1121(a) of P.L. 108-173. Federal Food, Drug, and Cosmetic Medicine Equity and Drug Safety Act Act (FFDCA), adding Sections 811- of 2000 (P.L. 106-387). Section Section 3. Inserts a new Section 804. Section 4. Inserts a new Section 804. 817. 1121(a) of the Medicare Prescription Drug, Improvement, and Also amends, deletes, or adds Also amends, deletes, or adds Section 16. Repeals Section 804 of Modernization Act of 2003 (P.L. 108- provisions in other sections of the provisions in other sections of the the FFDCA. 173) replaced Section 804 entirely. FFDCA; and the Internal Revenue FFDCA; and the Clayton Antitrust Code of 1986 [31 USC 26]; and the Act [15 USC 12 et seq.]; the Also amends, deletes, or adds Controlled Substances Import and Controlled Substances Import and provisions in other sections of the Export Act [21 USC 956]. Export Act [21 USC 956]; Section FFDCA; and the Controlled 271 [Infringement of Patent] of Title Substances Import and Export Act [21 35 [Patents]; and Section 351 of the USC 956]. Public Health Service Act [42 USC 262]. Findings No provision. No provision. Section 2. Findings. Includes No provision. findings that, although the United States is the largest market for prescription drugs, U.S. prices are "unjustly" higher than in other countries, and that allowing the importation of prescription drugs would save American consumers money and ensure access to safe and effective FDA-approved drugs. Direction to 804(b). Regulations. Section 801 of 804(a). Waivers Regarding 804(a). Importation of Prescription Section 2(b). Regulations. regulate the FFDCA allows only a drug's Commercial and Personal Drugs. The HHS Secretary shall Authorizes the HHS Secretary to manufacturer to import that drug. Importation of Prescription Drugs. provide, in regulations for importing promulgate regulations to carry out Section 804(b) requires the Secretary The HHS Secretary shall provide, in qualifying drugs by registered Section 812 [personal importation] of Health and Human Services regulations, a waiver of Section importers or from registered and directs the Secretary to CRS-7 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 (HHS), after consultation with the 801(d)(1) as long as the drug exporters, a waiver of Section promulgate interim final regulations United States Trade Representative complies with the standards of 801(d)(1) as long as the drug to carry out Section 813 [pharmacy and the Commissioner of Customs, to Section 801(a), which allows only complies with the standards of and wholesaler importation of promulgate regulations permitting certain drugs to be imported. A Section 801(a), which allows only prescription drugs] of the FFDCA (as pharmacists and wholesalers to import qualifying drug may not be imported certain drugs to be imported. A added by this section). Even if the prescription drugs from Canada into unless the drug meets certain qualifying drug may not be imported Secretary has not promulgated the United States. conditions [stated in 804(h)] or the unless the drug is imported by a regulations, Section 812 shall take imported drug is for personal use or pharmacy or a wholesaler who is a effect on the date of enactment of this 804(j)(2). Waiver Authority. The for use by a family member and not registered importer, or a by an Act and Section 813 shall take effect Secretary is authorized to grant for resale and meets the conditions in individual for personal or family- one year after enactment. waivers, either through rule-making Section 804(i), as below. member use (and not for resale) from or on a case-by-case basis, of the law a registered exporter. 813. Pharmacy and Wholesaler that allows only manufacturers to Importation of Prescription Drugs. A import FDA-approved drugs, to allow drug importation facility, pharmacy, individuals to bring in Internet pharmacy, or wholesaler may pharmaceuticals under conditions the import a prescription drug from Secretary determines appropriate. Canada or a permitted country into The Secretary must publish guidance the United States. describing the consistent circumstances in which waivers would be granted to individuals. Permitted Stipulates that the Secretary's 804(a)(4)(B). A "permitted country" 804(a)(4)(D). [For commercial 811*(4)(A). [Note: Section 811 does countries regulations would include only is Canada and, 180 days after the importation,] A "permitted country" not have a letter designating the Canada for imports by pharmacists publication of a report (see below), means Australia, Canada, a member beginning of this subsection, which an and wholesalers; does not specify Australia, a member country of the country of the European Union as of asterisk notes here.] Defines country for individual imports. European Union* or the European January 1, 2003,* Japan, New "permitted country" as a member of Free Trade Association,*** Japan, and Zealand, and Switzerland. the European Union as of December New Zealand. The Secretary may 31, 2003,* that is designated by the designate any additional country that 8 0 4 ( i ) ( 1 ) . Fo r p er so nal-use Secretary based on a report due to the has equivalent regulatory importation, includes Canada only. Senate HELP Committee and the requirements to ensure the safety and House Energy and Commerce effectiveness of drugs. Committee three years after enactment (see under "Study and report," below). CRS-8 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 813(d). Prohibits the importation of a prescription drug that had entered any country other than Canada or another permitted country after leaving the control of the manufacturer. Even when a drug comes from a permitted country, if it had been outside the manufacturer's control, the Secretary may prohibit its import if the Secretary determines that allowing it would present a risk to the public health. * The European Union as of January 1, 2003 consisted of the following 15 member states: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom. On May 1, 2004, 10 countries joined the European Union: Cyprus, the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia, and the Slovak Republic.**The European Economic Area consists of the European Union plus Iceland, Liechtenstein, and Norway. *** The European Free Trade Association consists of Iceland, Liechtenstein, Norway, Switzerland, and the member states of the European Union. Definitions 804(a). Definitions. Defines 804(a)(4). Definitions. 804(a)(4). Definitions. 811. Definitions. "importer" to mean a pharmacist or a Defines "importer," "pharmacist," Defines "registered exporter," Defines "drug importation facility" as wholesaler; "pharmacist" to mean a and "wholesaler" the same as current "registration condition," a "person, other than an individual person licensed by a state to practice law. "pharmacist," and "wholesaler" the importing a prescription drug under pharmacy, including the dispensing same as S. 2307. Section 812, located outside the and selling of prescription drugs; and Defines "exporter" to mean a person United States (other than a "wholesaler" to mean a person who is (or seeks to be) in the business Defines "exporter" to mean a person transporter) that engages in the licensed as a wholesaler or distributor of exporting a drug to the United who is in the business of exporting a distribution or dispensing of a of prescription drugs in the United States after submitting a registration; drug from Canada to individuals in prescription drug that is imported or States, but does not include the "registered exporter" to mean an the United States or that seeks to be in offered for importation into the manufacturer of the drug being exporter with an approved registration such a business pursuant to submitting United States." Defines "Internet imported. in effect; and "registration condition" a registration; "pharmacy" to mean a pharmacy" as a person that offers to to mean a condition that must exist for person licensed by a state to engage in dispense a prescription drug through a registration to be approved. the business of selling prescription an Internet website in interstate drugs at retail and employs 1 or more commerce, regardless of whether its pharmacists; "importer" to mean a physical location is in the United pharmacy, a group of pharmacies, or States. Defines "pharmacy" as a a wholesaler that is in drug importing person licensed by a state to dispense business or that seeks an approved prescription drugs or to provide registration to do so; and "registered pharmaceutical care. Defines CRS-9 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 importer" to mean a pharmacy, a "treating provider" as "a licensed group of pharmacies, or a wholesaler health care provider that (A) performs with an approved and in effect a documented patient evaluation registration. (including a patient history and physical examination) of an individual to establish the diagnosis for which a prescription drug is prescribed; discusses with the individual the treatment options of the individual and the risks and benefits of treatment; and maintains contemporaneous medical records concerning the individual; or (B) provides care to an individual as part of an on-call or cross-coverage arrangement with a health care provider described in subparagraph (A)." Defines "wholesaler" as a person licensed as a wholesaler or distributor of prescription drugs in the United States, but does not include the manufacturer of the drug being imported or an individual importing for personal use. Section 15(c). Anticounterfeiting Provisions; Distributors of Record. Amends Section 503(e) of the FFDCA as follows. Defines "distributor of record" as a person that takes title to or possession of a drug from manufacture; this includes a person that manufacturers, processes, packs, distributes, receives, holds, imports, or offers for importation, and this does not include a transporter. Defines "transporter" CRS-10 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 as the United States Postal Service, foreign government postal service, or a private carrier in the business of transporting packages. Defines "wholesale distribution" as the distribution of a drug to other than the consumer or patient but not including an intracompany sale or distribution by a transporter. Defines "prescription drug" as a drug Defines "covered prescription drug" Defines "prescription drug" as a drug 811*(5). Defines "prescription drug" subject to Section 503(b) [a drug as an approved drug under Section described in FFDCA Section similarly to current law [an FDA- intended for use by man that is not 505(b)(1) [an FDA-approved drug] 503(b)(1). Has the same definition approved drug], with additional safe for use except under the that is subject to Section 503(b)(1) [a for "qualifying drug" as S. 2307. exceptions: a drug manufactured supervision of a licensed practitioner] drug requiring a prescription]. through any biotechnology process, other than a controlled substance, a Defines "qualifying drug" as a including a therapeutic DNA plasmid biological product, an infused drug, covered prescription drug other than a product, a therapeutic synthetic an intravenously injected drug, a drug controlled substance, a biological peptide product of not more than 40 that is inhaled during surgery, or a product, an infused drug, an amino acids, a monoclonal antibody parenteral drug that the Secretary intravenously injected drug, or a drug product for in vivo use, and a determines poses a threat to the public that is inhaled during surgery. therapeutic recombinant DNA- health. derived product; a drug requiring 804(g)(2)(A). A "U.S. label drug" is refrigeration at any time; or a a drug approved for commercial photoreactive drug. distribution in the United States. 804(g)(2)(B)(i, iii). A "petition drug" is a drug named in a manufacturer's petition to the Secretary to stop its import. [See 804(g), below, regarding petitions.] "Qualifying laboratory" is defined as a laboratory in the United States that has been approved by the Secretary for the purposes of this section. CRS-11 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 Qualifying 804(c). Limitation. Regulations must 804(c). Sources of Exporting 804(c). Sources of Qualifying Drugs. No explicitly comparable provision; drugs ensure that all imported prescription Qualifying Drugs. An exporter must Same as S. 2307 except that the however, requires that an imported drugs meet the same safety and only export a drug that has a verified manufacturing establishment must be prescription drug must be FDA- efficacy standards as drugs approved chain of custody from the either inspected by the Secretary or approved. in the United States and that the manufacturer to the exporter. The registered under Section 510. The importer comply with all information, exporter must comply with the manufacturing establishment can be reporting, and testing requirements. following: the drug must have been in the United States or any foreign The Secretary is permitted to adopt manufactured in an FDA-registered country, as in S. 2307, but the such rules as necessary to safeguard establishment [registered under (h) or establishment can manufacture the public health or as a means to (i) of Section 510], which is located in drug either for distribution in the US facilitate the importation of the U.S. or any foreign country, and or for distribution in a permitted prescription drugs. the establishment manufactured the country. Canada is the only foreign drug for distribution in the U.S. and country from which the exporter can for distribution in a permitted export the drug; the importer can country; the drug came directly from import from a permitted country only. the manufacturing establishment or The exporter or importer must retain from an entity that, by contract with a sample of each lot of the drug the exporter, provides the exporter a sufficient for testing by the Secretary. chain of custody statement from the manufacturing estab lishment, identifying each prior sale, purchase, or trade with dates, names and addresses of all parties to the transaction; exporter agrees to permit the Secretary to inspect the statements and related records to determine accuracy; and agrees to allow the Secretary to inspect all facilities involved and all the contracting chain of custody parties; the foreign country from which the exporter will export the drug is a permitted country, and exporter ensures that during any period in which the drug was not in the drug manufacturer's control, the drug did not enter a non-permitted country. CRS-12 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 Relationship to No explicitly comparable provision; 804(g)(1). Compliance with Section 804(g)(1). Compliance with Section 813(b). Requirements. Requires that FDA approval however, the law requires that all 801(a) [Imports and Exports]. For 801(a). Similar to S. 2307. Each each imported prescription drug be imported drugs be FDA-approved. each exported qualifying drug, the qualifying drug exported or imported FDA-approved [Section 505] and exporter must comply with Section by the registered exporter or importer comply with FDA requirements 801(a) FFDCA standards subject to must be in compliance with Section regarding adulteration [Section 501] the import approval status, labeling, 801(a) standards regarding admission and misbranding [Section 502]. and standards for refused admission of the drug into the United States, Requires that the container have a criteria under this Act [Sections subject to paragraphs (2), (3), and (4) prominent and conspicuous label with 804(g)(2,3) and 804(j)]. [see below]. the following items: the lot number; the name, address, and phone number 804(g)(2)(A). Approval Status; 804(g)(2)(A,B). Section 505; of the drug importation facility; a Importation. A drug may be imported Approval Status. There is a general statement that the drug was imported, into the United States if (1) the presumption that a drug proposed for naming the country from which it Secretary has verified the source of export or import is an FDA-approved came; and a unique identifier, the exported drug, including that the drug if it complies with 804(c) and if indicating that the drug has been drug is approved for commercial it has the same active ingredient or imported, based on the national drug distribution in a specified foreign ingredients, route of administration, code of the prescription drug. country and that the establishment dosage form, and strength, according Requires that the drug comply with that manufactures the drug also to the labeling information (referred any other FFDCA requirements. manufactures the drug for distribution to in this subsection as a `U.S. label in the United States (referred to as a drug') as an FDA-approved drug that "U.S. label drug"); and (2) it has the is manufactured by or for the person same active ingredients, route of that manufactures the drug proposed administration, dosage form, and for export or import. A drug that strength as the U.S. label drug, meets the criteria stated above may be according to the label of the drug. imported into the United States. [Section 804(g)(2)(B) is described later in this document.] Testing 804(e). Testing. The importer or the No provision. No provision. No provision. manufacturer must conduct the required authenticity testing at a qualified laboratory. If the importer conducts these tests, the manufacturer must give the importing pharmacist or CRS-13 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 wholesaler the information needed to authenticate the product and confirm its labeling. Also, testing information must be kept in confidence and used only for testing or to otherwise comply with this Act. The Secretary may adopt rules to protect trade secrets and commercial or financial information that is privileged or confidential. Monitoring and No provision. 804(d)(1). Monitoring of Facilities. 804(d)(1). Inspection of Facilities. Section 10. Advance Notice of inspections The exporter must agree to assist the Similar to S. 2307 except it also Imported Prescription Drug Secretary to determine exporter allows the Secretary to have on-site, Shipments. Amends FFDCA Section compliance with all required day-to-day access to samples of such 801 to allow the Secretary to inspect conditions. The exporter must permit drugs. Also, any employee assigned drug imports at ports of entry. The the Secretary to assign one or more by the Secretary must carry out the person importing or offering for employees to conduct day-to-day on- functions of the section not less than importation the prescription drug site continuous monitoring of every three weeks and that such an must give the Secretary advance warehouses or other exporter owned, assignment remains in effect on a (between 24 hours and five days) controlled, or operated facility that continuous basis. notice of: the established name, relate to qualifying drugs; to have dosage form, and quantity of the day-to-day access to records including prescription drug; the name of the financial records; to verify the chain shipper; the name of the country from of custody of each qualifying drug, which the prescription drug monitor markings, and sample the originates; the country from which it exported drugs to assure compliance; is shipped; the name of the port of and to carry out other functions that entry; documentation of the original the Secretary determines necessary source of the prescription drug; the regarding compliance. The Secretary quantity of each lot of the prescription may allow periodic, rather than day- drug originally received by the to-day, inspections of a business with facility from that source; the lot or sufficient history of compliance. control number assigned to the prescription drug by the manufacturer of the prescription drug; the name, CRS-14 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 address, telephone number, and professional license number of the drug importation facility located in Canada or a permitted country; and certification from the drug importation facility located in a foreign country or from the manufacturer of the prescription drug that the prescription drug is approved for marketing in the United States and is not adulterated or misbranded and meets all labeling requirements under this Act. Failure to provide notice results in holding of drug at the point of entry. Section 13. Authority to Commission Other Federal and State Officials to Conduct Inspections. Amends the FFDCA to permit the Secretary to sign a memorandum of understanding with another federal agency or a state for its employees to conduct examinations and investigations for the purposes of enforcing compliance with this Act. The memorandum is to include provisions for ensuring adequate training and reimbursement. Reporting to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce is required on the joint activities. The Secretary may contract with a state to use State Board of Pharmacy personnel to CRS-15 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 conduct examinations and inspections required by this Act. Agreements with a state are effective only in that state and for facilities located in that state; and agreements are effective only at facilities that are jointly regulated by the Secretary and the other agency. Records of No provision. 804(d)(3). Certain Duties. The 804(d)(3). Certain Duties Relating to Section 15(a). Anticounterfeiting chain of Secretary shall verify the chain of Exporters. Similar to S. 2307 except Provisions; Required Records. custody custody of each qualifying drug from that these duties involve verifying the Amends Section 503(e) of the the drug manufacturer to the exporter. chain of custody of a statistically FFDCA by requiring the wholesale If the qualifying drug is exported to significant sample of qualifying drugs distributor of record, for each individuals for personal use, the from the manufacturing distribution, to provide to the Secretary is directed to randomly establishment, which may be recipient the identity of the select samples of the exports to accomplished by the use of anti- immediately previous distributor of determine whether the conditions counterfeiting or track-and-trace record from which the prescription required for individual imports are technologies, if available. Record drug was purchased; and, for each being met. The sampling process review is the same as S. 2307. wholesale distribution of an imported must allow a statistically significant However, the employees shall inspect, drug, to provide the purchaser with determination of compliance. The as the Secretary determines is identifying information, such as dates Secretary is directed to monitor the necessary, the warehouses and other and the names and addresses of all required markings of exports. facilities of other parties in the chain parties to each transaction. Requires of custody of qualifying drugs, and the distributor to keep the records determine whether the exporter is in available for two years for Secretarial compliance with all other registration inspection, including the immediately conditions. previous and subsequent distributors of all distributions, and, for imports, each previous and subsequent distributor, to the extent feasible. 804(h). Importers; Conditions for 804(d)(4). Certain Duties Relating to Importation. An importer may import Importers. The Secretary must a drug if it receives the drug directly inspect not less than every three from the mail, a common carrier, or a weeks the importer's places of CRS-16 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 vehicle or aircraft owned by the business that relate to the receipt and importer or a business organization of distribution of a qualifying drug, which the importer is a part. The including each warehouse or other personnel of the transporting entities facility owned or controlled by, or must have had exclusive custody of operated for, the importer at which the drug without the involvement of qualifying drugs are received or from any other entity including a wholesale which they are distributed to distributor. Although the wholesale p har macies. Dur ing these distributor, or any entity not the inspections, the Secretary (1) shall importer, cannot at any point have verify the chain of custody of a custody of the drug, the wholesaler statistically significant sample of could negotiate price and other q u a lifying d r u g s f r o m t h e processes for purchasing drugs from establishment in which the drug was exporters. manufactured to the importer, which may be accomplished by the use of anticounterfeiting or track-and-trace technologies; (2) may inspect, if necessary, the warehouses and other facilities of other parties in the chain of custody of qualifying drugs; and shall determine whether the importer is in compliance with all other registration conditions. Section 7. Wholesale Distribution of Section 8. Wholesale Distribution of Drugs; Statements Regarding Prior Drugs; Statements Regarding Prior Sale, Purchase, or Trade. Section Sale, Purchase, or Trade. Same as S. 503(e) of the FFDCA gives 2307. It also removes the reference to requirements of wholesale distributors manufacturer and authorized (guidelines). This bill would change distributor, but does not insert the exclusion of the manufacturer and registered exporter. authorized distributor to an exclusion of a registered exporter. It would also insert the requirement that a wholesale distributor is not exempt CRS-17 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 from providing to the person who receives the drug after export a statement identifying each prior sale, purchase, or trade of such drug including the date of the transaction and the names and addresses of all parties to the transaction. The Secretary may establish "alternative requirements" to identify the chain of custody of the drug through the wholesale distribution chain if the alternatives provide greater certainty and alternatives are economically and technically feasible. If the Secretary does promulgate final rules for "alternative requirements" then other conditions are amended. Each manufacturer distributing FDA approved drugs shall maintain records of authorized distributors who are distributors with an ongoing relationship with them to distribute the manufacturer's products. Charitable 804(i). Charitable Contributions. 804(k). Charitable Contributions. No provision. 813(g). Charitable Contributions. contributions Section 801(d)(1) of the Act, which Similar to MMA. Similar to current law. allows only the U.S. manufacturer of a drug to import it into the United States, will continue to apply to a product donated by a manufacturer of a drug to a charitable or humanitarian organization or foreign government. CRS-18 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 Repeal of No provision. Section 8. Repeal of Importation Section 9. Repeal of Importation Section 16(a). Conforming controlled Exemption Under Controlled Exemption Under Controlled Amendments. Repeals Section 1006 substances Substances Import and Export Act. Substances Import and Export Act. of the Controlled Substances Import exemption This section repeals the exemption Same as S. 2307. and Export Act. (Same as S. 2307.) authority of the Attorney General to allow imports of controlled substances for personal use under certain conditions. Registration of 804(f). Registration of Foreign 804(b)(1). Registration of Foreign 804(b)(1). Registration of Importers Section 8. Registration of importers and Sellers. Requires any Canadian Exporters. To register, an exporter and Exporters. To register, the Prescription Drug Importation exporters establishment engaged in the must submit to the Secretary: importer or the exporter (referred to Facilities. Adds to the FFDCA a new distribution of a prescription drug as the registrant) must submit to the Section 814, Registration of Certain imported or offered for importation the name and addresses of every place Secretary: Importers, to require a drug into the United States to register its of business of the exporter that relates importation facility, pharmacy, name and place of business with the to qualifying drugs, including each the name and addresses of every place Internet pharmacy, or wholesaler Secretary. Also requires that the warehouse or other facility owned or of business of the registrant including engaged in the importation or offering Canadian establishment register the controlled by, or operated for, the each warehouse or other facility for importation of prescription drugs name of its U.S. agent. exporter; and owned or controlled by, or operated into the United States, or in the for, the registrant; and dispensing of such drugs, to register with the Secretary. To register, the person must submit: [814(b)(1)(A)] the name and address of each drug importation facility, pharmacy, Internet pharmacy, or wholesaler at which, and all trade names under which, the registrant conducts business; and [814(b)(1)(B)] the name of each prescription drug to be imported into the United States. CRS-19 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 information necessary to demonstrate information necessary to demonstrate compliance with the conditions that the importer is in compliance relating to the sources of exported with registration conditions relating to drug; the monitoring of foreign the sources of exported drugs; the facilities; the marking of compliant inspection of facilities of the importer; shipments; fee payment; being the payment of fees; compliance with licensed as a pharmacy; and the standards referred to in Section compliance with Section 801(a) 801(a); and maintenance of records standards [federal government can and samples; and information sample and inspect to prevent the necessary to demonstrate that the i mp o r tatio n o f a d u l t e r a t e d , exporter is in compliance with misbranded, or non-FDA-approved registration conditions relating to the drugs]; sources of exported drugs; the inspection of facilities of the exporter and the marking of compliant shipments; the payment of fees; compliance with Section 801(a) standards; being licensed as a pharmacist; conditions for individual importation from Canada; and maintenance of records and samples. The exporter must agree to export The importer or the exporter must only qualified drugs; agree to not import or export any nonqualifying drug. to export only to persons authorized The exporter must agree to not export to import the drug; a qualifying drug to anyone who is not a registered importer, and to post a bond payable to the Treasury of the United States if, after opportunity for an informal hearing, the Secretary decides that the exporter has exported a drug to the United States that is not a qualifying drug or that is not in compliance with subsections (g). The CRS-20 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 bond amount is the lesser of the value of drugs exported by the exporter to the United States in a typical four-week period over the course of a year under this section; or $1,000,000. to submit to the jurisdiction of U.S. [814(b)(1)(C)] the name and address courts and supply the name and of an agent for service of process in address of its U.S. agent for service of the United States. process; to monitor compliance with all The registrant agrees to ensure and registration conditions, and correct monitor compliance with each and promptly report any registration condition, to promptly noncompliance conditions to the correct any noncompliance, and to Secretary; promptly report to the Secretary any such noncompliance; and to submit a compliance plan that to submit a plan as to how the shows how the exporter will correct registrant will comply with this any violation; agreement. to notify the Secretary of any changes The exporter must agree to update any [814(b)(2)] timely notification of any in information provided in the information provided in the change in the information. registration or in the compliance plan; registration or in the compliance plan. and to comply with any other conditions The Secretary may require other for registration that the Secretary conditions for registration that would requires to protect the public health protect the public health while while permitting imports. permitting imports of qualifying drugs by pharmacies, groups of pharmacies, wholesalers as registered importers, and individuals. CRS-21 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 The registrant must agree to notify the Secretary of a recall or withdrawal of a drug distributed in a permitted country that the registrant has or intends to export or import; provide for the return to the registrant of such a drug; and cease or not begin the exportation or importation of such a drug unless the Secretary has notified the registrant that imports may proceed; and to enforce a contract under subsection (c)(3)(B) (records of chain-of-custody of a drug) against a party in the chain of custody of a qualifying drug and under the authority of the Secretary to inspect such statements to determine their accuracy and agree to inspections. 814(d)(1). Authority. "Nothing in this section authorizes the Secretary to require an application, review, or licensing process for a drug importation facility, pharmacy, or wholesaler." 814(d)(2). Importation by Individuals. This section does not apply to a prescription drug imported by an individual for personal use or to a commercial transaction conducted between an Internet pharmacy and an individual. CRS-22 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 813(h). Jurisdiction. The district courts of the United States shall have jurisdiction in an action brought by the United States against a person importing or offering for importation a prescription drug in violation of the requirements of this section. Section 8(c). Importation; Failure to Register. Prohibits delivery of a prescription drug until the drug importation facility, pharmacy, Internet pharmacy, or wholesaler is registered. Requires that the drug be held in a secure facility and not be transferred. Licensing as No provision. 804(f). Licensing as a Pharmacy. 804(h). Licensing as Pharmacist. A No provision. pharmacies and The Secretary must determine that the condition of registration is that the pharmacists exporter intending to export a exporter agrees that a qualifying drug qualifying drug for personal use is (1) will be exported to an individual only authorized under foreign law to if the Secretary has verified that the dispense prescription drugs, and (2) exporter is authorized under Canadian that the foreign country's programs to law to dispense prescription drugs; regulate pharmacists are comparable and the exporter employs enough to U.S. state programs; or, if the persons licensed under Canadian law exporter is not a licensed pharmacist, to dispense prescription drugs to that the exporter employs a sufficient dispense safely the qualifying drugs number of pharmacists licensed by exported by the exporter to one of the states and assigns to those individuals, and the exporter assigns pharmacists responsibility for to those persons responsibility for dispensing drugs that individuals will dispensing such qualifying drugs to import into the United States for individuals. personal use. CRS-23 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 Fees No provision. 804(e). Fees. As a condition of 804(e). Importer Fees. An importer Section 14. Adds to the FFDCA a registration, an exporter must pay a must pay the Secretary a $10,000 fee new Section 740A, Fees Relating to semi-annual fee with the first payment along with the registration Prescription Drug Importation. included with the registration. The submission. In addition, the importer Requires the Secretary to establish a aggregate fee total for each fiscal year must pay the Secretary a semiannual user fee program under which a drug must cover the costs of administering fee. importation facility, pharmacy, this program. These costs are for Internet pharmacy, or wholesaler monitoring foreign facilities; The Secretary shall ensure that the registering with the Secretary under developing, implementing, and aggregate total of fees collected for a Section 814 shall be required to pay maintaining a system to mark fiscal year from all importers is the Secretary a fee beginning for shipments to indicate registration sufficient, and no more than FY2005. Directs the Secretary to compliance; and co nd ucting necessary, to pay the costs of determine the amount annually based inspections within the United States to administering this section with respect on anticipated costs of enforcing this determine compliance with required to registered importers for a fiscal Act, publish the fee 60 days in conditions for importers and for year. These are costs for inspecting advance of each fiscal year, hold a imports for personal use. The the facilities of importers; reviewing public meeting and provide time for Secretary may use these fees only for qualifying drugs offered for import to public comment. Directs the these costs. For the first year, importers; and determining the Secretary to use the collected fees, however, the Secretary may collect a compliance of importers with without further appropriation, to lesser aggregate total of fees taking registration conditions. The aggregate enforce the Act. into account the lesser number of total of fees collected shall not exceed registered exporters and the capacity 1% of the total price of drugs The fee shall be payable annually and of that group to pay the administrative imported annually to the United States only once for each facility. From 30 costs. Authorizes the collection of a by registered importers under this days after the due date, a registered semi-annual fee from each exporter section. facility may not import a prescription set by the Secretary as a pro rata share drug until all fees are paid. of the aggregate costs, including the The fee for an individual importer number of employees that the shall be a reasonable estimate by the Requires the Secretary, 60 days after Secretary has assigned to that Secretary of the semiannual share of the end of FY2005 and annually exporter. the importer of the volume of drugs thereafter, to submit a report to the imported by importers. The Secretary Senate Committee on Health, must annually adjust the fees to Education, Labor, and Pensions and accurately reflect the actual costs, and the House Committee on Energy and to not exceed, in the aggregate, 1% of Commerce describing implementation the total price of drugs imported of the user fee authority during the CRS-24 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 annually to the United States by fiscal year and the use by the registered importers under this Secretary of the fees. section. Subject to appropriations acts, the fees collected by the Secretary are available only to the Secretary and are for the sole purpose of paying the costs of administering this program. 804(f). Exporter Fees. Requirements for exporters are similar to the requirements for importers, as above, except that the aggregate exporter fees must cover the cost of monitoring foreign facilities; developing, implementing, and sustaining a system to mark shipments to indicate compliance with all registration c o n d i t io ns; a nd c o n d u c t i n g inspections within the United States to determine compliance with conditions for licensing exporting pharmacists and for importation from Canada. Packaging No explicitly comparable provision; 804(d)(2). Marking of Compliant 804(d)(2). Marking of Compliant Section 15(b). Anticounterfeiting however, the law requires that all Shipments. The exporter must agree Shipments. Same as S. 2307. Provisions; Electronic Track and imported drugs be FDA-approved and to mark each shipping container of Trace Technology. Directs the carry the FDA-approved labeling. drugs identifying that the shipment is Secretary to require, no later than in compliance with all registration December 31, 2007, the adoption and conditions. The markings may use of electronic track and trace include anti-counterfeiting or track- technology for a prescription drug at and-trace technologies and shall be the case and pallet level that will designed to prevent unauthorized identify each sale, purchase, or trade affixation. of that case or pallet (including the date of transmission and the names CRS-25 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 and addresses of all parties to the transaction). 804(h). Approved Labeling. Requires 804(g)(3)(A). Labeling; Importation 804(g)(3)(A). Section 502; Labeling; 813(c). Approved Labeling. Requires a drug manufacturer to give the by Importer. If a qualifying drug is Importation by Registered Importer. that a drug importation facility importer written authorization to use, offered to a pharmacist or wholesaler If an importer imports a qualifying demonstrate to the Secretary that the at no cost, the approved labeling for for import or is imported, it must bear drug, the drug must bear the labeling labeling of the prescription drug to be the prescription drug. a copy of the labeling approved by approved for the drug by FDA, imported into the United States FDA, whether or not the copy bears without regard to whether the copy complies with the requirements of the trademark involved. The bears the trademark. The label must Sections 502 [adulteration] and 503 Secretary shall provide a copy of the include the name and location of the [misbranding]. Requires that the approved labeling to the registered manufacturer, the lot number assigned Secretary approve or deny the exporters upon request. by the manufacturer; and the name, application within 60 days of receipt location, and registration number of and notify the applicant of the the importer. The Secretary shall decision and, if the application is provide a copy to the registered denied, provide the reason for the importer involved, upon request of the denial. Requires the Secretary to importer. maintain an up-to-date list of application status. 813(e). Prohibition of Commingling. Prohibits a drug importation facility, pharmacy, Internet pharmacy, or wholesaler from commingling imported and not imported prescription drugs. Requires that a pharmacy or Internet pharmacy that dispenses a prescription drug imported from Canada or a permitted country affix on each dispensed container of the drug the label required by FDA unless such a label is already affixed to the container. 804(g)(3)(B). Labeling; Importation 804(g)(3)(B). Section 502; Labeling; by Individual. If a drug is imported Importation by Individual. If a drug CRS-26 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 by an individual, it must bear a label is imported by a registered exporter to providing the directions for use by the an individual, the drug must bear a consumer, and a copy of any special label providing the directions for use labeling that would be required by the by the consumer, and bear a copy of Secretary had the drug been dispensed any special labeling that would be by a pharmacist in the United States, required by the Secretary had the drug without regard to whether the special been dispensed by a pharmacist in the labeling bears the trademark involved. United States, without regard to The Secretary shall provide to the whether the special labeling bears the registered exporter involved a copy of trademark involved. The Secretary the special labeling, upon request of shall provide to the registered the exporter. exporter involved a copy of the special labeling, upon request of the exporter. Records 804(d)(1). Information and Records. Section 804(c) requires, among other 804(j). Maintenance of Records and Section 15(a). Anticounterfeiting Drug importers must provide criteria, the manufacturer to provide a Samples. Both importers and Provisions; Required Records. information that includes: the name chain-of-custody statement to the exporters must maintain records Requires the wholesale distributor to and amount of the active ingredient of exporter. required under this section for not less create and maintain for two years the drug, the dosage form of the drug, than two years; and maintain samples available to the Secretary, for each the date the drug is shipped, the of each lot of a drug required under wholesale distribution, records of the quantity shipped, information about this section for not less than two immediately previous and its origin and destination, the price years. immediately subsequent distributors paid by the importer, the original of record; and, for each imported source of the drug, the amount of each drug, records of each previous and lot received from that source, the each subsequent distributor, as manufacturer's lot or control number, feasible. and the importer's name, address, and license number. Section 9. Adds to the FFDCA a new Section 815, Maintenance and For a prescription drug imported Inspection of Records for Prescription directly from the first foreign Drugs. Authorizes the Secretary to recipient from the manufacturer, there establish, by regulation, requirements must be documentation indicating that relating to the establishment and the drug came directly from the maintenance, for not longer than two manufacturer and was subsequently years, of records by a drug CRS-27 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 shipped by that recipient to the importation facility, pharmacy, importer; that the amount being Internet pharmacy, or wholesaler imported is not greater than the engaged in the importation of quantity that was originally received; prescription drugs into the United and verification that each batch of the States, or in the dispensing of such drug has been statistically sampled drugs; and any person that processes, and tested for authenticity and packages, distributes, receives, holds, degradation prior to importation. or transports a prescription drug Samples of subsequent shipments of imported under this subchapter. these drugs must also be tested for authenticity and degradation. If the Secretary has reason to believe that an imported prescription drug For a prescription drug not imported presents a risk to the public health, directly from the first recipient in the requires that the drug importation foreign country, there must be facility, pharmacy, Internet pharmacy, documentation demonstrating that or wholesaler that imports the each batch in each shipment of the prescription drug, and each person drug has been statistically sampled that processes, packages, distributes, and tested for authenticity and receives, holds, or transports the degradation prior to importation. prescription drug permit the Secretary's officer or employee, with Also, the importer or manufacturer appropriate credentials and a written must certify that the drug is FDA- notice, "at reasonable times, within approved, properly labeled, not reasonable limits and in a reasonable adulterated, and not misbranded, manner," to have access to and copy provide laboratory records of all records, in any format, at any authenticity testing, including data, location, needed to determine whether and evidence that testing was the prescription drug presents a risk to conducted in an approved U.S. the public health. Requires the laboratory. The importer is required Secretary to prevent the unauthorized to provide any other information that disclosure of any trade secret, the Secretary determines is necessary confidential, or privileged to ensure the public health. information. The Secretary's requirements do not apply to personal-use imports. CRS-28 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 804(d)(2). Maintenance by the Importers of drugs are to maintain Secretary. Records regarding records for two years. imported prescription drugs "covered products" must be provided to the Secretary, and then kept for such time as the Secretary determines to be appropriate. Manufacturer No provision. 804(g)(2)(B). Approval Status; 804(g)(2)(C). Section 505; Approval No provision. requirements Petition by Manufacturer; General Status; Notice by Manufacturer; Provisions. A drug manufacturer may General Provisions. A manufacturer file a petition with the Secretary of any drug that may be imported requesting that a drug's import cease. must submit to the Secretary a notice The petition must claim that the drug that includes each difference in the is changed from the U.S. label drug in drug from a condition established in a manner that, if made to the U.S. the approved application for the U.S. label drug in the United States, would label drug beyond the variations need a supplemental application. The provided for in the application; any petition must also state whether, difference in labeling; the date on under FDA regulations, the change which the drug with such difference could be made pending an was, or will be, introduced for application's approval or whether, in commercial distribution in a permitted consideration of a bioequivalence country; and such additional matter, the changed drug could not be information as the Secretary may sold before such an approval. The require; or states that there is no manufacturer's chief executive difference in the drug from a officer, chief legal counsel, and chief condition established in the approved medical officer must each certify that application for the U.S. label drug the information in the petition is beyond the variations provided for in complete and true. Unless the petition the application and differences in makes a nonequivalence claim, the labeling. petitioner pays a fee that is equivalent to the PDUFA fee established for a The manufacturer must notify the human drug application for which government of the permitted country clinical data on safety or effectiveness that has approved (or has an is required for approval. Subject to application pending) the drug's CRS-29 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 appropriations acts, the collected fees commercial distribution that it is are available to the Secretary to pay filing this notice. The notice must for administering this section. The include the material (with verified Secretary must grant or deny a English translation, if necessary) that petition within 180 days of its filing. the manufacturer submitted to the permitted country in seeking marketing approval. The chief executive officer and the chief medical officer of the manufacturer involved must each certify in the notice that the information provided is complete and true; and provide a copy of the notice to the Federal Trade Commission and to the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice. If a notice submitted shows that the difference would require the submission of a supplemental application if made as a change to the U.S. label drug, the person that submits the notice shall pay to the Secretary a fee in the same amount as would apply if the person were paying a PDUFA fee for a supplemental application. Subject to appropriations Acts, fees collected by the Secretary are available only to the Secretary and are for the sole purpose of paying the costs of reviewing notices. Timing of notice submission to the Secretary: CRS-30 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 For a notice regarding drug differences that would require approval before being marketed, the notice must be submitted to the Secretary at least 120 days before the changed drug is introduced for commercial distribution in a permitted country, unless the country requires that earlier distribution, in which case the notice must be submitted no later than the day the drug is commercially introduced in that country, and annually thereafter. For a notice regarding drug differences that would require a supplemental application but not require pre-market approval or for a drug that would not require a supplemental application, the notice must be submitted no later than the day the drug is commercially introduced in that country. The Secretary shall treat these notices as if they related to a manufacturing change to the U.S. label drug under Section 506A of the FFDCA; and shall review and approve or disapprove the notice within 120 days of its submission. If the review would require an inspection by the Secretary of the manufacturing establishment, such inspection shall be authorized. Through the Internet website of the Food and Drug Administration, the Secretary shall readily make available CRS-31 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 to the public a list of notices submitted and the status of the Secretary's review, including determinations. The Secretary shall promptly update the Internet website with any changes to the list. 804(g)(2)(D). Approval Status; 804(g)(2)(D). Notice; Drug Petition; Drug Changes Requiring Difference Requiring Prior Approval. Prior Approval. A petition raising a If the notice regarding an imported "bioequivalence consideration" drug shows that it requires the claims either a "possible approval of a supplemental nonequivalence claim" or a application before the difference "nonequivalence claim." If the could be make to the U.S. label drug, petition raises a possible the Secretary must notify registered nonequivalence claim, the petitioning exporters, registered importers, the manufacturer must notify the foreign Federal Trade Commission, and the country that approved the drug for Assistant Attorney General that the commercial distribution in writing notice has been submitted with that there is a claim submitted to the respect to the drug involved. If the Secretary and that the petition has Secretary has not made a with it the information submitted to determination whether a supplemental the foreign country to obtain an application regarding the U.S. label approval there. The drug may drug would be approved or continue to be imported and receivers disapproved by the date on which the are notified that there is a possible drug involved is to be introduced for nonequivalence claim. If the commercial distribution in a permitted Secretary decides that the petition country, the Secretary must order that drug is not bioequivalent, then the the importation of the drug involved Secretary may grant the petition and from the permitted country cease imports may cease. during the period in which the Secretary completes review of the I f the petition makes a notice; and promptly notify registered nonequivalence claim, the Secretary exporters, registered importers, the must order imports to cease during the Federal Trade Commission, and the petition review, and if the finding is Attorney General of the order. If the CRS-32 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 that the drug is not bioequivalent, Secretary decides that such a then the order to cease imports supplemental application regarding continues. the U.S. label drug would not be approved, the Secretary shall stop all If a petition makes a possible- importation of the drug involved from nonequivalence claim or a the permitted country, and notify the nonequivalence claim and if the permitted country that approved the petition drug was approved for drug for commercial distribution of commercial distribution by FDA the determination; and promptly and/or a foreign government on or notify registered exporters, registered after January 1, 2004, the Secretary importers, the Federal Trade may not accept the petition unless the Commission, and the Assistant petitioner submits information Attorney General of the showing that: (1) the drugs differ due determination. If the Secretary to a difference in the legal approval determines that the supplemental requirements between the U.S. and application regarding the U.S. label the foreign country; or (2) the drug would be approved, the p etitio ner has sub mitted a Secretary shall vacate the order to supplemental application to the cease trade, if any, and permit Secretary or to the foreign importation of the drug and promptly government to remove the difference notify registered exporters, registered between the petition drug and the U.S. importers, the Federal Trade label drug. If the Secretary ceased Commission, and the Assistant imports of a drug, the Secretary shall Attorney General of the rescind the order promptly after a determination. supplemental application is approved. The Secretary must rescind any order if false, fictitious, or fraudulent statements in the petition influenced the Secretary's decision. 804(g)(2)(C). Approval Status; 804(g)(2)(E). Notice; Drug Petition; Drug Changes Not Difference Not Requiring Prior Requiring Prior Approval. For a Approval. If the imported drug does petition drug which would have been not require the approval of a allowed to be sold pending the supplemental application before the CRS-33 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 supplemental application approval, difference could be made to the U.S. the importation may continue while label drug the following shall occur: the Secretary considers the During the period in which the notice manufacturer's petition to cease is being reviewed by the Secretary, importation. For importation to the authority under this subsection to continue, the importer must inform all import the drug involved continues in purchasers that the manufacturer is effect. If the Secretary determines making a claim that the drug is that such a supplemental application different than the U.S. label drug and regarding the U.S. label drug would the registered exporter must notify all not be approved, the Secretary shall individuals importing the drug from order that the importation of the drug the exporter for individual personal involved from the permitted country use that the manufacturer is making cease, shall notify the permitted the claim. If the Secretary decides country that approved the drug for that the supplemental application commercial distribution of the regarding the U.S. label drug would determination, and shall promptly not be approved, the Secretary shall notify registered exporters, registered grant the petition and order that importers, the Federal Trade imports of that drug cease. Commission, and the Assistant Attorney General of the determination. 804(g)(2)(F). Notice; Drug Difference Not Requiring Approval; No Difference. If the differences between the U.S. label drug and the drug to be commercially distributed in a permitted country would not require a supplemental application, the Secretary may not stop the importation and shall promptly notify registered exporters and registered importers. CRS-34 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 804(g)(2)(G). Differences in Active Ingredients, Route of Administration, Dosage Form, or Strength. A manufacturer of a U.S. label drug must submit an application under Section 505(b) [new drug approval] of the FFDCA for a drug that it manufactures for distribution in a permitted country when each active ingredient of the drug is related to an active ingredient of the U.S. label drug [for purposes of this application, active ingredients are related if they are "the same; or different salts, esters, or complexes of the same moiety."], and there is no drug for export from at least half of the permitted countries with the same active ingredients, route of administration, dosage form, and strength as the U.S. label drug. The application must request approval of the drug for the indications for which the U.S. label drug is approved and include the information [with a verified English translation, if necessary] that the manufacturer submitted to the government of the permitted country for purposes of obtaining approval for that drug's commercial distribution; include a right of reference to the application under Section 505(b) for the U.S. label drug; and include such additional information as the Secretary may require. This CRS-35 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 application shall be submitted to the Secretary not later than the day on which the previous information is submitted to the government of the permitted country. The Secretary shall promptly notify registered exporters, registered importers, the Federal Trade Commission, and the Assistant Attorney General of a determination to approve or to disapprove an application. Secretary's 804(l)(1). Commencement of No provision. No provision. No provision. actions Program. The drug import program can begin only if the Secretary first certifies to Congress that its implementation would pose no additional risk to public health and safety, and would result in a significant reduction in the cost of covered products to American consumers. 804(l)(2). Termination of Program. No provision. No provision. No provision. The authority of the Secretary to terminate the program is restricted to the procedure in this section. Between 12 and 18 months after the regulations are implemented, if the Secretary certifies to Congress that, based on substantial evidence, in the opinion of the Secretary, the benefits of the implementation of the import program do not outweigh any detriment, drug imports under the section would cease 30 days after the CRS-36 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 certification is submitted. However, the certification may not be submitted unless, after a public hearing, the Secretary finds it is more likely than not that implementation will result in an increased risk to the public health; identifies, in qualitative and quantitative terms, the nature and causes of the increased risk; considers whether measures can be taken to avoid, reduce, or mitigate the increased risk and, if those measures would require additional statutory authority, to report to Congress describing needed legislation; identifies, in qualitative and quantitative terms, the benefits that would result from the program, including reductions in the cost of drugs to U.S. consumers, which would allow them to obtain needed medications without foregoing other necessities of life; and, in specific terms, compares the detriment with those benefits and determines the benefits do not outweigh the detriment. 804(g). Suspension of Importations. 804(b)(4). Suspension and 804(b)(4). Suspension and Section 6. Adds new Section 817, If the Secretary discovers a pattern of Termination. The Secretary may Termination. Same as S. 2307, except Suspension of Importation. Allows counterfeit or violative products, the suspend a registration if, after notice it refers to the importer as well as the the Secretary to immediately order the agency must suspend importation of and opportunity for a hearing, the exporter. suspension of the importation of a that specific prescription drug or that exporter fails to maintain substantial particular prescription drug or a specific importer. The suspension compliance with registration particular dosage form by a drug must stay in effect until the Secretary conditions. In addition, the Secretary importation facility, pharmacy, investigates and determines whether shall suspend immediately, without Internet pharmacy, or wholesaler or a CRS-37 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 the public is being adequately prior notice, the exporter's country (but not an individual protected from counterfeit and registration if the exporter has importing for personal use or an violative drug products under existing exported a non-qualifying drug, not individual engaged in an Internet regulations. met the requirements relating to a pharmacy transaction) if the Secretary U.S. label drug, or exported a drug to determines it presents a risk to the an individual who did not meet the public health. Allows this action to conditions under law. The Secretary be appealed; requires that the must give the exporter a hearing Secretary, after providing opportunity within 10 days of the suspension. If for an informal hearing, confirm or the Secretary determines that there terminate the order within 30 days. would be no further violations, the An order under this section shall not Secretary may reinstate the suspended be subject to judicial review. registration. If the Secretary determines that a drug After notice and the opportunity for a importation facility, pharmacy, hearing, the Secretary may terminate Internet pharmacy, or wholesaler, or a a registration if the exporter has a country (but not an individual pattern or practice of violating one or importing for personal use or an more registration condition. The individual engaged in an Internet Secretary may terminate a registration pharmacy transaction) is engaged in a permanently or for a fixed period of pattern of importation that violates the not less than one year. A registration Act's requirements, the Secretary may will have no legal effect if, during the immediately order suspension of period in which a registration is importation of prescription drugs terminated, the exporter or a partner from that person or country. or principal officer of the enterprise assisted in the preparation of the Allows that this action be appealed; registration. and requires the Secretary, after providing opportunity for an informal hearing, to confirm or terminate the order within 30 days. An order under this section shall not be subject to judicial review. CRS-38 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 804(k). Construction. Nothing in this 813(i). Effect of Section. Similar to section limits the Secretary's authority current law. Nothing in this section relating to the importation of [ P h a r m a c y a n d Wh o lesa ler prescription drugs, other than with Importation of Prescription Drugs] respect to Section 801(d)(1), which limits the authority of the Secretary allows only the manufacturer to relating to the importation of import a prescription drug. prescription drugs (including the interdiction of prescription drugs that are unapproved, adulterated, or misbranded), other than with respect to the banning of anyone other than the manufacturer from importing a prescription drug that had been supplied as a charitable contribution. 804(b)(2). Approval or disapproval 804(b)(2). Approval or disapproval 814(b)(3). Requires the Secretary, of registration. The Secretary must of registration. Same as S. 2307. not later than 60 days after receipt of approve or disapprove a registration a completed registration, to assign a within 90-days of its submission. If registration number to each registered the registration is disapproved, the drug importation facility, pharmacy, Secretary must notify the exporter as Internet pharmacy, and wholesaler, to why. After a registration has been and notify the registrant of the receipt denied, if and when the exporter is in of the registration. compliance, the Secretary must notify the exporter. Within 30 days of 814(c). Requires that the Secretary receiving an exporter's compliance provide for and require electronic plan, described above, the Secretary filing of registrations, with adequate must decide if the change affects the authentication protocols to allow exporter's registration approval and identification of the registrant and inform the exporter. validation of the data. 804(b)(3). Publication of Contact 804(b)(3). Publication of Contact Requires that the Secretary keep an Information for Registered Exporters. Information for Registered Exporters. up-to-date list of registrants and make The Secretary shall post publicly on Same as S. 2307 except it does not it available to the public on an the FDA website a list of registered require a requested link on the FDA Internet website and through a exporters, including contact website to the Internet site of the toll-free telephone number. CRS-39 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 information; update this information; exporter. and provide, if requested by the exporter, a link to the exporter's website. Studies and Section 1122. Study and Report on 804(a)(4)(B)(ii). Report. Within 18 No provision. 811*(4)(B). Report. Requires that reports Importation of Drugs. The law months after enactment, the Secretary the Secretary, three years after requires the Secretary, in consultation must submit to Congress a report that enactment, submit to the Senate with appropriate government describes the impact of the new drug Committee on Health, Education, agencies, to conduct a study on the import program on the safety and Labor, and Pensions and the House importation of drugs in the United integrity of the U.S. prescription drug Committee on Energy and Commerce States pursuant to Section 804 of the distribution system, the prevalence in a report that includes a list of Federal Food, Drug, and Cosmetic the United States of counterfeit, permitted countries and why the Act (as added by Section 1121 of P.L. adulterated, or misbranded drugs, and Secretary determined that drug 108-173). The Secretary shall submit patient drug therapy; describes the imports from such countries would the report to Congress not later than potential impact of permitting imports not increase risk to the public health. 12 months after the enactment of this from additional countries; includes Requires the Secretary to list those Act. proposed legislation to improve the countries from which prescription safety, efficiency, and efficacy of the drug imports are not permitted and Section 1123. Study and Report on drug importation program. Requires why and what possible actions those Trade in Pharmaceuticals. The law the Secretary also, in consultation countries might take to avoid, reduce, requires the President's designees to with the Federal Trade Commission, or mitigate increased risk. Authorizes conduct a study and report on issues to evaluate the extent to which the the Secretary to determine whether to related to trade and pharmaceuticals. new import program achieves lower designate as permitted other countries [The conference report on H.R. 1, prices through competition in the U.S. at any time after submission of the which became P.L. 108-173, provides prescription drug market, and to report. detail regarding the reports required identify how the import program by Sections 1122 and 1123.] could be improved to meet that Adds [in Sec. 4 and Sec. 14] new objective. FFDCA sections 511(f) and 740A to require the Secretary to report to Congress annually on the implementation of the user fee authority and the use of those fees. Enforcement No provision. Section 3(b). Prohibited Acts. Section 4(b). Prohibited Acts. Section 2(c). Prohibited Act. Amends Section 301 of the FFDCA, Similar to S. 2307, but refers to sale Amends Section 301 of the FFDCA CRS-40 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 as amended by Section 1121(b) of by a pharmacist rather than an by prohibiting the dispensing or P.L. 108-173, to prohibit the importer importer. offering to dispense a prescription of a qualifying drug, imported for drug imported into the United States commercial purposes, to sell that drug in violation of the requirements of the unless the drug is sold at retail as it is new Section 813 (relating to dispensed to a customer of the pharma c y a nd wholesaler importer, or is sold or traded to the importation). registered exporter from which the importer imported the drug. It also prohibits an individual who imports the drug for personal use from selling or trading that drug. Prohibits making false, fictitious, or fraudulent statements in filing a petition to stop a drug's importation; if made, requires the maker to be imprisoned not more than 10 years, fined, or both. Section 3(c). Civil Penalty. Amends Section 303 of the FFDCA to make technical corrections to the numbering of the provision. A person who knowingly violates the revised Act by providing false statements that were a material factor in the Secretary's decision to issue an order to cease importation is liable for a civil penalty not to exceed a reasonable estimate of the gross revenue that would have been collected from sales of qualifying drugs by the registered exporter during the period for which the order was in effect. Section 3(e). Amendment of Certain Provision. The Secretary may not CRS-41 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 send a warning notice to an individual who is importing a qualifying drug for personal use unless the importation is not in accordance with Section 804. Section 4(e)(1). Anticompetitive Practices Relating to Importing and Exporting Drugs to the United States. Amends the Clayton Act (15 USC 12 et seq.) to add a new Section: Section 27. Restraint of Trade Regarding Prescription Drugs. Section 27(a) makes it "unlawful for any person engaged in commerce ..." to charge a price to, deny or restrict supplies to, or refuse to do business with a registered exporter, other person that exports prescription drugs to the United States, a registered importer, or other person that distributes, sells, or uses prescription drugs imported to the United States under Section 804 of the FFDCA more than to others who do not export or import under Section 804. It is also unlawful to fail to submit a required manufacturer notice in the required time or provide information requested by the Secretary; to submit a notice with "a materially false, fictitious, or fraudulent statement;" fail to submit a timely application regarding differences between the drug that may be imported and another drug; to fail to provide a copy CRS-42 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 to the permitted country; to make false statements; or to fail to timely provide information requested by the Secretary; to "cause there to be a difference (including a difference in active ingredient, r o ute o f administration, dosage form, strength, fo r mula tion, manufa c tur ing establishment, manufacturing process, or person that manufactures the drug) between a prescription drug for distribution in the United States and a prescription drug for distribution in Australia, Canada, a member country of the European Union as of January 1, 2003, Japan, New Zealand, or Switzerland for the purpose of restricting importation of the drug to the United States ..."; to refuse to allow a required inspection or fail to conform to good manufacturing practice; or to "engage in any other action that the Federal Trade Commission determines to unfairly restrict competition under Section 804 ...." Section 27(b). Presumption. "A difference (including a difference in active ingr edient, route of administration, dosage form, strength, formulatio n, ma nufa c tur ing establishment, manufacturing process, or person that manufactures the drug) between a prescription drug for distribution in the United States and a CRS-43 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 prescription drug for distribution in" a permitted country in Section 804 of the FFDCA "made after January 1, 2004, shall be presumed to be for the purpose of restricting importation of the drug to the United States unless (1) ... the difference was required by the country in which the drug is distributed; (2) the Secretary ... determines that the difference was necessary to improve the safety or efficacy of the drug; or (3) the person manufacturing the drug for distribution in the United States has given notice to the Secretary ... that the drug for distribution in the United States is not different from a drug for distribution in ..." at least half of the permitted countries. Section 27(c). Affirmative Defense. "It shall be an affirmative defense to a charge that a person has violated paragraph (1), (2), (3), (4), or (5) of subsection (a) that the higher prices charged for prescription drugs sold to a person, the denial of supplies of prescription drugs to a person, the refusal to do business with a person, or the specific restriction or delay of supplies to a person is not based, in whole or in part, on (1) the person exporting or importing prescription drugs to the United States ...; or (2) the person distributing, selling, or using prescription drugs imported to the United States...." CRS-44 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 Section 27(d). Definitions. Applies the definitions in Section 503(b)(1) of the FFDCA for prescription drug, and in new Section 804 for registered importer and registered exporter. Section 4(e)(2). Applicability of Amendments to Importation Under the Pharmaceutical Market Access and Fair Trade Act of 2004. [sic; S. 2328 was renamed the Pharmaceutical Market Access and Drug Safety Act of 2004 before it was introduced.] Section 27 of the Clayton Act shall apply to personal- use importation from Canada. A notice filed under paragraph 6 above will apply to notices required in new Section 804(g)(2)(C)(i) that are not submitted by the dates required under (c)(1)(C,D). Section 4(f). Exhaustion. Amends Section 271 of Title 35 USC by inserting a new subsection that would reverse judicial precedent holding that sales of patented goods outside the United States do not exhaust the U.S. patent. Under this provision, goods that were the subject of authorized foreign sales by the U.S. patent holder may be imported in the United States without regard to the U.S. patent. Section 6. Civil Actions Regarding Section 7. Civil Actions Regarding Section 7. Debarment for Repeated Property. Amends Section 303 of the Property. Same as S. 2307. or Serious Drug Importation FFDCA: Penalties by adding (g)(1) to Violations. Amends Section 306(b) CRS-45 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 authorize the Attorney General to of the FFDCA to allow the Secretary commence civil action in any federal to debar a person (other than an court if a person is importing a drug individual importing for personal use that violates the Act. The court action or an individual engaged in an may enjoin the alienation or Internet pharmacy transaction) from disposition of property or issue a importing a prescription drug for up restraining order to prohibit any to five years if the person "has been p erson from withdrawing, convicted of a felony for conduct transferring, removing, dissipating, or relating to the importation into the disposing of such property or property United States of any prescription of equivalent value; and to appoint a drug; or ... has engaged in a pattern of temporary receiver to administer the importing or offering for import a order. Such proceedings must be prescription drug that presents a risk carried out in the same manner as to the public health." Allows the applies under Section 1345 of Title 18 Secretary to withdraw the debarment USC [regarding injunctions against if the conviction on which it was mail fraud]. based is reversed or if it "serves the interests of justice and adequately protects the integrity of the ... prescription drug importation process." Section 7(e). Amends Section 801 by adding a subsection (s), Importation of Prescription Drugs by Debarred Persons. Requires that a prescription drug imported by a debarred person be held at its port of entry or moved to a secure facility, if appropriate, and not otherwise be transferred. While the prescription drug is held under a bond, it may not be delivered. While the drug is being held, prohibits its transfer by any person from the port of entry or the secure facility where it is held. Allows for the delivery of a prescription drug to a non-debarred CRS-46 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 person if that person shows, at their own expense, that the drug complies with FFDCA requirements. Section 9. Enforcement Through Denial of Deduction for Certain Advertising Expenses. Amends the Internal Revenue Code of 1986 by adding a new section: Section 280L. Advertisin g Expenditures of Taxpayers Who Discriminate Against Foreign Sellers of Prescription Drugs to Domestic Consumers. In general, no tax deduction is allowed unless the taxpayer certifies that it took no direct or indirect action to prevent or place conditions on the authorized importation of a qualifying drug into the United States from a registered exporter to a pharmacy or an individual. The Secretary will decide how the certification must be made and what fees to charge to cover the cost of confirming the certification. Advertising includes direct-to- consumer advertising and any activity designed to promote the use of the drug directed to providers or others who may make decisions about a drug's use (other than the provision of free samples). The amendment will apply to taxable years beginning after enactment of this Act. Section 10. Compliance Through Allowance of Research and Development Tax Credit. Amends CRS-47 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 Section 41 of the Internal Revenue Code of 1986 to increase the amount of credit by 20% if the taxpayer certifies that it has taken no direct or indirect action to prevent the authorized importation of qualifying drugs into the United States from a registered exporter to a pharmacy or individual, and has not set conditions on import terms. The Secretary will decide how the certification is made and what fees should be charged to cover the costs of confirming the certification. 804(j). Standards for Refusing 804(g)(4). Section 501; Standards for Section 11. Authority to Mark Admission. A qualifying drug from a Refusing Admission. Similar to S. Prescriptio n Dru g s Refused registered exporter may be refused 2307. Numbers (1) through (4) apply Admission into the United States. entry into the United States only if: if the import is from a registered Amends Section 801 of the FFDCA the shipping container does not bear exporter to an individual. (as amended by Section 10(a) of this the required markings; the container Act) to allow the Secretary to require or markings appear to be counterfeit 804(i)(2). Notice Regarding Drug the owner or consignee of the drug to or appear to have been tampered with; Refused Admission. If a registered label any prescription drug refused the container appears damaged in a exporter ships a drug to an individual admission indicating that, with the way that could affect the strength, and the drug is refused admission to owner or consignee responsible for all quality, or purity of the drug; the the United States, a written notice labeling expenses, until the Secretary Secretary becomes aware that the shall be sent to the individual and to determines that the prescription drug drug may be counterfeit, been the exporter that informs them of the has been brought into compliance prepared, packed, or held under refusal and the reason for the refusal. with this Act. Amends Section 502 of insanitary conditions, or if the drug the FFDCA so that if the prescription was not made or stored under good drug does not carry the label after the manufacturing processes; the Secretary has informed the owner, it Secretary has obtained an injunction shall be considered misbranded. This against the drug, prohibiting does not apply to a personal-use distribution in commerce, or has import or a commercial transaction withdrawn the approval of the drug; between an Internet pharmacy and an or individual. This section does not limit CRS-48 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 the authority of the [HHS] Secretary or the Secretary of the Treasury to require the marking of prescription drugs refused admission under any other provision of law. if the manufacturer has instituted a 804(k). Drug Recalls. A 813(f). Drug Recalls. Requires that recall of the drug. manufacturer of a drug imported from a drug importation facility promptly a permitted country shall promptly provide the Secretary and any person inform the Secretary if the drug is to whom the prescription drug was recalled or withdrawn from the distributed a notice that the drug has market in a permitted country; how been recalled or withdrawn from the the drug may be identified, including market. Requires that the notification lot number; and the reason for the include identifying information recall or withdrawal. The Secretary (including the lot number) and the shall enter into an agreement with the reason for the recall or withdrawal. government of each permitted country to receive information about recalls and withdrawals of prescription drugs in the country; or monitor recalls and withdrawals of prescription drugs in the country using any information that is available to the public. The Secretary may notify registered exporters, registered importers, wholesalers, pharmacies, or the public of a recall or withdrawal of a prescription drug. Section 5(a). Creates a new Section Section 6. Creates in the FFDCA a Section 5(a). Creates in the FFDCA a 805 in the FFDCA, Disposition of new Section 805. Disposition of new Section 816, Administrative Certain Drugs Denied Admission, to Certain Drugs Denied Admission. Detention. An officer or qualified establish that any import shipment of Similar to S. 2307 except it (1) refers employee of the FDA may order the drugs valued at less than $10,000 in to the Secretary of Homeland Security detention of any prescription drug that violation of standards set in Sections as the refuser of admission; (2) does it believes to present a risk to the 801(a) or 801(d)(1) shall be refused not state that this section does not public health. If the Secretary admission. These standards are transfer to the Secretary responsibility approves, requires that the drug be CRS-49 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 referred to in Section 804(j) and mean for carrying out this section; and detained for up to 30 days, labeled as that the drugs are not sufficiently states that procedures for carrying out detained and in a secure facility. marked. this section shall be established within Until the Secretary releases the drug 90, rather than 30, days of enactment or the detention period expires, Drugs refused admission must be of this Act. prohibits the transfer of the drug from destroyed unless the U.S. Attorney detention, including delivery pursuant General determines they are needed as to the execution of a bond. Allows evidence or potential evidence. In the claimant to appeal the detention general, refused admission and and the Secretary must confirm within destruction of drugs may be done five days or the order will be without notice to the importer, owner, terminated. or consignee of the drugs, with receipts and record keeping done on a Section 5(b) amends Section 801 of summary basis to efficiently utilize the FFDCA by adding a paragraph (r), federal resources. This section has no Temporary Hold at Port of Entry. effect on laws regarding shipments of With approval by the Secretary or a drugs that are valued equal to or designated official (director of the greater than $10,000, nor does this district in which the drug is located, section transfer to the Secretary or a senior official of the director), responsibility for carrying out this directs an FDA officer or qualified section. Procedures to carry out this employee who believes there is a risk section must be established within 30 to public health and was unable to days of enactment of this Act. inspect to request the Secretary of the Treasury to detain the prescription drug for 24 hours to allow inspection. Directs FDA, when detaining a drug, to notify the state of the port of entry. Prohibits the transfer of a detained drug or its removal or alteration of the detention label. Prohibits delivery of the prescription drug being held pursuant to the execution of a bond. This subsection does not apply to a drug imported by an individual for personal use or to a commercial transaction between an Internet pharmacy and an individual. CRS-50 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 Personal use 804(j). Waiver Authority for 804(i)(1). Personal Use; Conditions 804(i)(1). Individuals; Conditions for 812. Personal Importation. Allows Importation by Individuals. for Importation. Individuals can Importation From Canada. Similar to an individual to import a prescription 804(j)(1). Declaration. Congress import up to a 90-day supply of a S. 2307 except it also allows the drug from Canada or a permitted declares that the Secretary should use qualifying drug if the drug is prescribing practitioner to be licensed country into the United States for discretion when enforcing the current accompanied by: a copy of a where the individual receives care; personal use (not for resale) if the legal prohibition against persons prescription that is valid under federal refers to Canada specifically, rather prescription drug is purchased from a importing drugs or devices. The and state laws and was issued by a than "the exporting country;" and licensed pharmacy in Canada or a Secretary should focus enforcement practitioner who, under the state law requires that the Canadian document, permitted country and dispensed in on cases where the importing may of which the individual resides, is in addition to the U.S. prescription, be compliance with that country's pose a significant threat to public authorized to administer drugs; a marked as filled. The individual must applicable laws; it is imported for health. When the importation is statement that provides sufficient have given the registered exporter a personal use (not for resale) by the clearly for personal use and the information for the Secretary to complete list of all drugs used by the individual; it is imported physically prescription drug or device does not determine whether the prescription individual for review by those who by the individual; it does not exceed a appear to present an unreasonable risk meets those regulations, including the dispense the drug. 90-day supply during any 90-day to the individual, the Secretary should prescriber's licensure; and the period; and the prescription drug is exercise discretion to permit the documentation required by the Section 4(c)(3). Not less than 15 days accompanied by a copy of a importation by the individual. exporting country to dispense a drug. after the enactment of this Act and prescription valid in a state and All prescriptions must be marked to until 60 days from promulgation of cosigned by a prescribing physician in 804(j)(3). The Secretary is required indicate they have been filled to the interim rule, the Secretary shall, Canada or the permitted country or, if to grant waivers, by regulation, so prevent duplicative filling by another through the Internet website of the the prescription drug is available in persons can import for personal use pharmacist. The Secretary can Food and Drug Administration, make Canada or the permitted country up to a 90-day supply of an FDA- prohibit from import drugs that were readily available to the public a list of without a prescription, a copy of the approved prescription drug from a approved und er accelerated persons licensed in Canada to valid prescription signed by a licensed pharmacy in Canada, so long procedures for serious or life- dispense prescription drugs who are pharmacist licensed in that country. as the drug's final dosage form was threatening illness. willing to export drugs to individuals made in an FDA-registered facility, in the United States. Compassionate Use. Authorizes the came from a registered Canadian 804(i)(2). The exporter must notify Secretary to permit an individual to seller, was accompanied by a valid the individual carrying a qualifying Section 4(c)(4). The provisions on import up to a 90-day supply of a prescription, and was imported under drug into the United States for disposal of drugs denied admission drug that is not approved by the conditions the Secretary determines personal use that the shipping and civil action regarding property Secretary under FFDCA Section 505 were necessary to ensure public container must be intact and be (Sections 6 and 7 of this bill) do not if the importation is for continuation safety. marked as in compliance with apply to personal-use imports by of personal use by the individual for requirements that the drug is individuals. treatment, begun in a foreign country, approved for distribution in a of a serious medical condition. permitte d c o untr y a nd is Section 4(d). Amendment of Certain manufactured in a facility that also Provision [Section 801]. If a drug is manufactures it for U.S. distribution; imported by a person not in the CRS-51 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 and the drug has the same ingredients, importation business or shipped by an route of administration, dosage form, unregistered exporter and is refused and strength as the U.S. label drug. admission, the Secretary shall notify the individual of the refusal, that the 804(i)(3). There is a presumption that import is not subject to a waiver, and the drug imported is "an approved that the individual may legally import drug under Section 505(b)(1) if the certain prescription drugs from criteria described in subsection registered Canadian exporters, a list (g)(A)(i-ii) are met." [sic; probably of which is posted on the FDA should be (g)(2)(A)(i-ii)] website. Section 4. Additional Waivers Section 5. Additional Waivers Regarding Personal Importation; Regarding Personal Importation; Enforcement Policies of Secretary. Enforcement Policies of Secretary. Amends Section 801 by establishing Similar to S. 2307, except that it a new category of waivers for requires that the Secretary establish individuals and allows the Secretary by regulation a waiver of standards to establish by regulation a waiver of for personal use imports if the drug t h e r e q u i r e me n t t h a t o n l y was dispensed to the individual while manufacturers import drugs if the that person was in a foreign country drug was dispensed in the United and met that country's laws and States by a licensed pharmacist or regulations. In addition, the quantity practitioner and the individual of the imported drug may not exceed traveled from the United States with a 90-day supply if the drug is the drug, and the individual returns to dispensed in Australia, Canada, a the United States with the drug. The member country of the European drug cannot appear adulterated, and Union as of January 1, 2003, Japan, not be more than a 30-day supply. It New Zealand, or Switzerland; must be accompanied by a statement otherwise, the limit is a 14-day that the individual seeks to import the supply. drug under a personal import waiver, and complies with such additional standards the Secretary decides are needed to protect the public health. The Secretary may, by regulation, waive standards for personal use CRS-52 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 imports if the drug was dispensed to the individual while that person was in a foreign country, met that country's laws and regulations, and was approved for commercial distribution in the foreign country in which the drug was obtained. The drug is entering with the individual and does not appear adulterated, does not exceed a 10-day supply, has a statement from the individual seeking to import the drug under a personal waiver, and complies with such additional standards that the Secretary determines to be appropriate to protect the public health. The Secretary may not administer any enforcement policy that permits imports of drugs in violation of this act or Section 351 of the Public Health Service Act. The Secretary's authority to establish waivers of the standards in Section 801(a) of the FFDCA for personal use imports is not limited by this Act; waivers must not, however, be more permissive than current FDA regulatory guidance.# # "In deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel may consider a more permissive policy in the following situations: (1) when the intended use is appropriately identified, such use is not for treatment of a serious condition, and the product is not known to represent a significant health risk; or (2) when (a) the intended use is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; (b) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; (c) the product is considered not to represent an unreasonable risk; and (d) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than three month supply)and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country." FDA Regulatory Procedures Manual at [http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9pers.html]. CRS-53 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 Rulemaking No provision. Section 3(d)(1). Implementation; Section 4(c)(1)(A)(i). Section 8(b). Requires that the deadlines Rulemaking. The Secretary must Implementation; Rulemaking; Secretary, not later than one year after publish, within 90 days of enactment Promulgation by Secretary. Same as enactment, promulgate regulations to and without notice and comment, an S. 2307. carry out Section 814 [to register interim final rule for implementing prescription drug importation Section 804; and publish a final rule facilities]. by one year after the interim rule. Effective dates No provision. Section 3(d)(2). Implementation; Section 4(c)(1)(A)(ii). Effect of Section 2(b)(1)(B). Directs that Personal Importation from Canada. Rules. An individual may import a personal-use importation be allowed Until 45-days after the promulgation prescription drug for personal or from enactment of this Act, even if of the interim final rule, an individual family-member use from a registered the Secretary has not issued may import up to a 90-day supply of exporter beginning when the interim regulations. a qualifying drug from Canada, for rule is promulgated. personal or family-member use, according to conditions in this act. A registered importer may import a Section 2(b)(2)(B). Directs that prescription drug from Canada pharmacy and wholesaler importation beginning when the interim rule is be allowed one year after enactment promulgated. of this Act even if the Secretary has not issued regulations. A registered importer may import a prescription drug from the other Section 8(b). Directs that registration permitted countries beginning one of prescription drug importation year after enactment. facilities requirements take effect on the effective date of the final Section 4(c)(1)(B). Registrations regulations or, if the final regulations submitted by entities in Canada that have not been made effective, one are significant exporters of year after enactment. prescription drugs to individuals in the United States as of the date of the enactment of this Act will have review priority during the period in which the interim rule is in effect. The Secretary must approve or disapprove of the registration within CRS-54 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 30 days, rather than the 90-day limit that this bill sets for approval or disapproval of registration in general. Section 4(c)(1)(C). Regarding drugs to be imported from Canada, (1) a manufacturer's notice that, because of differences from the U.S. label drug, requires prior approval from the Secretary must be submitted to the Secretary within 30 days of enactment; (2) a notice regarding a drug that does not require prior approval must be submitted to the Secretary within 90 days of enactment. Section 4(c)(1)(D). For drugs to be imported from Australia, a member country of the European Union as of January 1, 2003, Japan, New Zealand, or Switzerland, (1) a manufacturer's notice that, because of differences from the U.S. label drug, requires prior approval from the Secretary, must be submitted to the Secretary within 180 days of enactment; (2) a notice regarding a drug that does not require prior approval must be submitted to the Secretary within 270 days of enactment. Section 4(c)(2). Implementation; Personal Importation from Canada. For the 60 days after the interim rule is promulgated, an individual may import a prescription drug from CRS-55 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 Canada for personal or family- member use (rather than for resale), according to conditions in this act. Appropriations 8 0 4 ( m) . Au th o riza t i o n o f No provision. No provision. No provision. Appropriations. Authorizes to be appropriated such sums as are necessary to carry out this section. Protection No provision. No provision. No provision. Section 3. Protection Against against Adulterated Prescription Drugs. adulterated Amends Section 801(h) of the prescription FFDCA [as added by P.L. 107-188] to drugs include prescription drugs along with food, as follows. Directs the Secretary to give high priority to improving FDA informatio n management systems to allow the Secretary to better allocate resources, detect the intentional adulteration, and facilitate the importation of prescription drugs. Also requires the Secretary to improve linkages with other federal regulatory agencies, states and Indian tribes to ensure the safety of imported prescription drugs. Internet No provision. No provision. No provision. Section 4. Adds to the FFDCA a new pharmacies Section 511, Internet Pharmacies. 511(a). Definitions. Defines the terms "advertising service provider," "designated payment system," "federal functional regulator," "restricted transaction," "unlawful Internet pharmacy request," "credit," "creditor," "credit card," "electronic CRS-56 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 fund transfer," "financial institution," "money transmitting business," and "money transmitting service." Includ es references to the Communications Act of 1934 [47 USC 230(f)], the Gramm-Leach- Bliley Act [15 USC 6809; note: the bill also cites 21 USC 6805(a), perhaps in error], the Truth in Lending Act [15 USC 1602], the Electronic Fund Transfer Act [15 USC 1693a], and the Uniform Commercial Code [Article 4A]. In particular, defines "Internet pharmacy" as "a person that dispenses or offers to dispense a prescription drug through an Internet website in interstate commerce in the United States regardless of whether the physical location of the principal place of business of the Internet pharmacy is in the United States or in another country." Defines "unlawful Internet pharmacy request" as "the request, or transmittal of a request, made to an unlicensed Internet pharmacy for a prescription drug by mail (including a private carrier), facsimile, phone, or electronic mail, or by a means that involves the use, in whole or in part, of the Internet." 511(b,c). Licensing of Internet Pharmacies. To dispense a prescription drug to a person in the United States, requires that an Internet CRS-57 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 pharmacy be licensed with the Secretary and have its principal place of business in the United States, Canada, or a permitted country. Requires that the license application include verification of compliance, in each state in which the Internet pharmacies seeks to dispense prescription drugs, with all federal and state laws regarding the practice of pharmacy and the manufacturing and distribution of controlled substances and, for an Internet pharmacy in Canada or a permitted country, verification regarding compliance with applicable laws of that country. Also requires the application to include verification that the Secretary has not terminated a previous Internet pharmacy license of the owner, that the owner will permit inspections by the Secretary, and that any agreement between the Internet pharmacy and a patient releasing liability for negligence is null and void. Identification Requirements. Requires that the Internet pharmacy website include the street address and telephone number of each place of business; the names of the supervising and Internet service pharmacists; names of all states or countries where the pharmacy and pharmacists are licensed or otherwise authorized to CRS-58 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 dispense prescription drugs; name, address, telephone number, and state of licensure of any health care practitioner to whom the Internet pharmacy makes referrals; and a statement that it will dispense prescription drugs only after receipt of a valid prescription. Professional Services Requirements. Requires an Internet pharmacy to maintain patient medication profiles, conduct prospective drug use reviews, ensure patient confidentiality in accordance with the Health Insurance Portability and Accountability Act of 1996, offer "interactive and meaningful consultation by a licensed pharmacist," establish a mechanism to report errors and suspected adverse reactions and to document responses, develop system to inform about drug recalls, educate about disposal of medications, assure sale "is in accordance with a prescription from the treating provider of the individual," and verify prescription validity by mail or electronic mail receipt from the treating provider. If the prescription is for a controlled substance, the Internet pharmacy must confirm with the treating provider that the prescription is accurate and must provide the individual's name and address, identity and quantity of the drug, date prescription was presented to the Internet pharmacy, date and CRS-59 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 time of the verification request, and the name, telephone, fax, and e-mail contacts of the Internet pharmacy contact person. If the treating provider does not respond within 72 hours or informs the pharmacy that prescription is inaccurate or expired, the Internet pharmacy may not fill prescription. The Internet pharmacy must maintain records of direct communications with treating providers. Licensure Procedure. Requires that the Secretary assign an ID number and notify applicant of license application receipt and issue a license within 60 days if pharmacy complies with all required conditions. Directs the Secretary to require electronic submission of application and to ensure adequate authentication protocols. Requires that the Secretary keep an up-to-date list of licensees and make the list available to the public by an Internet website and a toll-free telephone number. Licensing Fee. The licensing fee for the year in which an Internet pharmacy first submits an application is $5,000. Requires that the Secretary publish, at least 60 days before the start of each fiscal year, and allow 30 days for comment, the licensing fee CRS-60 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 based on anticipated costs of enforcing requirements of this section in the subsequent year. Requires that the Secretary use, without further appropriation, the fees to carry out this section. The fee is due October 1 of each year and payable only once for each Internet pharmacy. If the Internet pharmacy has not paid the fee 30 days after the due date, prohibits it from dispensing drugs until it pays. Requires the Secretary, in 2005 and each subsequent year, to submit a report to Congress describing the implementation of the licensing fee authority and the use of the fees collected. Allows the Secretary to terminate a license if the Internet pharmacy has a pattern of noncompliance, made an untrue statement in the license application, or is in violation of an applicable federal or state law. Requires that, before renewing a license, the Secretary conduct an evaluation of compliance that may include testing of the website and other systems and a physical inspection of the records and premises. Authorizes the Secretary to award a renewable five-year contract to operate the licensing program, with annual performance reviews. 511(d). Providers of Interactive Computer Services or Advertising Services. Establishes that these providers are liable if they accept CRS-61 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 advertising for a prescription drug from an unlicensed Internet pharmacy or accept advertising stating a physician's prescription is not needed to obtain a prescription drug. 511(e). Policies and Procedures Required To Prevent Payments for Unlawful Internet Pharmacy Requests. Requires regulations within a year of enactment regarding design (using, for example, authorization codes) of the payment system (with system participant participation, if feasible) to prevent or block restricted transactions. Establishes that there be no liability for blocking or refusing to honor a restricted transaction. Requires that the Federal Trade Commission and other federal functional regulators (as defined in the Gramm-Leach-Bliley Act, 15 USC 6809) enforce this section taking into consideration the person's history and extent of compliance, the extent to which the person knew the transaction related to an unlawful Internet pharmacy request, and the feasibility of any specific remedy. 511(f). Reports Regarding Internet- Related Violations of Federal and State Laws on Dispensing of Drugs. Directs the Secretary to award a grant or contract to develop and maintain a system of identifying unlicensed Internet pharmacy websites or those CRS-62 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 in violation of federal or state laws; reporting these to state medical and pharmacy licensing boards, the Attorney General, and the Secretary; and submitting reports each fiscal year to the Secretary. Section 4(b). Prohibited Acts. Amends FFDCA Section 301, adding violations of Section 511 including drug sale or Internet pharmacy ownership, representing that a prescription drug may be obtained without a prescription, or accepting advertising from an Internet pharmacy without having a copy of the pharmacy's license on file. Section 4(c). Links to Illegal Internet Pharmacies. Amends FFDCA Section 302, stating that U.S. district courts and courts of the territories shall have jurisdiction to order an interactive computer service to remove or disable access to a website that violates this section. States that relief shall be available after notice and opportunity to appear; shall not oblige the provider to actively or passively monitory activity for violations; and shall specify the provider to which the relief applies. Section 4(d). Requires that the Secretary, within one year of enactment, promulgate interim final regulations consistent with the CRS-63 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 Verified Internet Pharmacy Sites certification program developed by the National Association of Boards of Pharmacy. States that the licensure requirement will take effect no later than 90 days after the publication of interim regulations. Section 4(e). Return to Sender. Requires that a shipment of a prescription drug from an unlicensed Internet pharmacy be refused admission and that the Secretary return it to the pharmacy at the pharmacy's expense. Directs the Secretary to return to the pharmacy at the pharmacy's expense a refused shipment from a licensed Internet pharmacy and to notify the individual and the Internet pharmacy along with the reason. Prohibits the return of a prescription drug that is required to be destroyed. Prohibition of No provision. No provision. No provision. 813(a)(2). Limitation to Certain port shopping Ports. Allows the Secretary to limit to a reasonable number the ports of entry in the United States through which a prescription drug may be imported under this section. 813(c)(3)(B). Lists; Ports. Requires the Secretary to maintain an updated list of ports through which a prescription drug may be imported under this section and to make the list CRS-64 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 available to the public on an Internet website. Section 12. Prohibition of Port Shopping. Prohibits entry of the prescription drug if it has previously been refused admission under Section 801(a), unless the person reoffering the prescription drug affirmatively establishes, at the expense of the owner or consignee of the prescription drug, that the prescription drug complies with the applicable requirements of this Act, as determined by the Secretary. This section does not apply to a personal- use import or to a commercial transaction between an Internet pharmacy and an individual. Anti- Section 15(d). Anticounterfeiting counterfeiting Programs. Requires the Secretary to programs establish a "Counterfeit Alert N e t wo r k" to no tify heal t h professionals and the public of counterfeit drugs; develop, publish, and keep up-to-date (quarterly) an Internet accessible reference document to identify prescription drugs marketed in the United States, Canada, and other countries as the Secretary permits. Directs the Secretary to develop and publish a range of materials, including those to help the identification and reporting of counterfeit drugs, practice guidelines (in cooperation with drug CRS-65 S. 2307 (Grassley 4/8/04) Current law: Reliable Entry for Medicines at Medicare Prescription Drug, Everyday Discounts through S. 2493 (Gregg 6/2/04) Improvement, and Modernization Importation with Effective S. 2328 (Dorgan 4/21/04) Safe Importation of Medical Act of 2003, enacted 12/8/2003 as Safeguards (REMEDIES) Act of Pharmaceutical Market Access Products and Other Rx Therapies Topic P.L. 108-173 [117 Stat. 2464] 2004 and Drug Safety Act of 2004 (IMPORT) Act of 2004 supply chain members) for the sale and distribution of drugs, and revised model rules (in cooperation with the National Association of Boards of Pharmacy) for state licensure of wholesalers. ------------------------------------------------------------------------------ For other versions of this document, see http://wikileaks.org/wiki/CRS-RL32568