The Enhancing Drug Safety and Innovation Act is an important effort to respond to consumers’ increasing concerns about the inadequacy of current safeguards protecting the public from unreported risks of prescription drugs. The above science and consumer health groups urged the Senate HELP Committee to consider a full range of drug safety reform proposals before acting on any legislation. The committee is holding a hearing today on the Enzi-Kennedy bill, but the groups have recommended numerous alternative legislative provisions and strategies that they urged the Senators to consider adopting, including suggestions contained in the recent IOM report, a survey of FDA scientists conducted by the Union of Concerned Scientists, a report by the National Research Center for Women & Families, recent articles by FDA experts, and bills introduced by Senators Grassley and Dodd, and by several members of the House of Representatives.
We are deeply concerned about the weakened safeguards at the FDA, and believe that in the coming months there will be an important opportunity to review the information and recommendations that have been made in the last few months and incorporate some of these suggestions into new, stronger legislation.
Moreover, we urge that the HELP Committee develop legislation to increase resources for safety reviews and surveillance, before and after FDA approval decisions are made. The current user fee law (PDUFA) restricts almost all user fees for use in speeding the review of products, permitting only a miniscule percentage to be used for the review of safety data. We are especially concerned that the bill shifts the safety focus from before an approval decision is made to post-market surveillance and studies conducted after a drug is approved for market.
Based on these concerns, we urge the Committee and the full Senate to take the time necessary to examine these proposals thoroughly, and to significantly revise and strengthen any FDA legislation that moves through the Senate this year and in the next Congress.
Center for Medical Consumers
Center for Science in the Public Interest
Government Accountability Project
National Research Center for Women & Families
National Women’s Health Network
Title II Community AIDS National Network
Union of Concerned Scientists
Victim Advocates: Eric Swan and Kim Witczak