Number: RL32797
Title: Drug Safety and Effectiveness: Issues and Action Options After FDA Approval
Authors: Susan Thaul, Domestic Social Policy Division 
Abstract: This report examines issues related to drug safety, specifically in the context of the regulatory process that Congress and the FDA have established for ensuring that drugs are safe and effective. It includes a primer on drug approval: how drugs are approved and come to market, including FDA's role in that process. It also describes FDA and industry roles once drugs are on the pharmacy shelves, the postmarket or post-approval period. It moves on to a discussion of the problems in identifying and resolving postmarketing safety and effectiveness issues that are raised most frequently in the debate. It outlines actions that a variety of analysts have suggested to improve the situation, both ones that FDA could adopt on its own and others for which legislation would be necessary.
Pages: 36
Date: January 24, 2007