Dear Senator Enzi, Senator Kennedy, and Members of the HELP Committee:
We were disappointed to hear that you are considering marking up S. 3807 “The Enhancing Drug Safety and Innovation Act” before holding a hearing. The recent Institute of Medicine (IOM) report, The Future of Drug Safety: Action Steps for Congress, makes a number of recommendations that deserve serious Senate consideration. In addition, another recent report, FDA Advisory Committees: Does Approval Mean Safety, provides data on approval decisions and conflicts of interest that the Senate should discuss.
As you know, the HELP Committee has not held a hearing on drug safety since March 2005, and we strongly believe a new hearing would be in the public interest. We respectfully suggest that the new IOM report provides a thoughtful framework for vigorous and open discussion of how best to improve FDA’s drug safety programs. The IOM report “recommends that Congress provide oversight and enact any needed legislation to ensure compliance to both FDA and drug sponsors…” The report also highlights the need to have Congress appropriate adequate resources for enhanced FDA drug safety programs, to hold industry and researchers accountable for making drug safety study results public, and to establish performance goals for safety.
We appreciate your commitment to strengthening the FDA, and share your belief that it is time for action. Nevertheless, we strongly urge you to postpone a markup of this bill until a hearing is held. The above mentioned reports, as well as recent specific drug safety concerns (e.g. Cox 2 inhibitors Vioxx and Bextra, SSRI antidepressants and stimulants to treat attention deficit disorder) combine to make a powerful case for thoughtful action to fix the parts of FDA that are currently broken. A rush to pass legislation that is inconsistent with the recommendations of the IOM, we believe, would squander an opportunity for Congress and the public to reap the benefit of recommendations crafted by a diverse committee of experts on drug safety. It is for these reasons that we urge you not to proceed with legislation until the public and the scientific community has the opportunity to testify and inform the legislative process.
Center for Medical Consumers
Center for Science in the Public Interest
National Research Center for Women & Families
National Women’s Health Network
Our Bodies Ourselves
Reproductive Health Technologies Project
Title II Community AIDS National Network