Number: RL33986
Title: FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective
Authors: Susan Thaul, Domestic Social Policy Division 
Abstract: Some of the issues the 110th Congress considered remain of concern. Why offer a financial incentive to encourage pediatric studies when FDA has the authority to require them? How does the cost of marketing exclusivity-including the higher prices paid by government-compare with the cost of the needed research? What percentage of drug labeling includes adequate pediatric information because of BPCA and PREA? Does the law provide FDA with sufficient authority to act and does FDA choose to so act? These kinds of questions-determining what information clinicians and consumers need, how to then develop and disseminate it; how to balance carrots and sticks; and how to consider cost and benefit-could not only help the 111th Congress evaluate BPCA and PREA, but also inform its consideration of healthcare reform.
Pages: 22
Date: December 2, 2008