September 18,2007

Grassley urges conferees to support strong FDA reforms

WASHINGTON — Sen. Chuck Grassley said the upcoming September 30 anniversary of Vioxx being pulled from the market is a good reminder about the need for Congress to embrace reforms passed by the Senate and House earlier this year in separate legislative proposals for the Food and Drug Administration.

In a letter to the leaders of the conference committee that’s crafting a final bill, Grassley said, “Both houses of Congress passed FDA reform bills that attempt to address serious problems at the FDA. Let’s not undo those efforts by reporting a weaker bill out of conference.”

Grassley has conducted active oversight of the FDA and documented shortcomings and conflicts with the drug safety agency’s pre-market review and post-marketing surveillance of drugs, biologics, devices and veterinary medicines. He has called the FDA’s relationship with the drug industry “too cozy” and revealed how agency leaders have acted to suppress scientific dissent regarding agency actions and drug-safety recommendations.

“Public safety is at stake,” Grassley said. “Congress needs to do everything it can with this legislation to make the FDA more independent, rigorous and responsive in its work. Unfortunately, the case for reform gets stronger all the time, as new questions continue to emerge about FDA actions and inaction.”

One of the reforms Grassley urges congressional negotiators to include in their final conference report is a Grassley amendment that senators approved in May with a vote of 64 to 30. The measure would improve pharmaceutical companies compliance with FDA directives, including label changes, post-approval studies and communicating important patient information such as newly identified risks.

A separate amendment offered by Grassley during Senate debate on the FDA Revitalization Act lost by just one vote. This initiative would have made the FDA office that studies drugs after they’re on the market an equal partner with the FDA office that initially approves drugs for all post-approval decisions related to the safety of drugs that are on the market. Grassley said again today that this reform is fundamental to improving the FDA’s ability to monitor the safety of FDA-approved drugs and devices.

Strengthening the Office of Drug Surveillance and Epidemiology has been a central focus of Grassley’s effort to fix problems at the FDA. In a commentary published earlier this year in the Journal of the American Medical Association, two members of the Institute of Medicine committee that evaluated FDA’s drug safety system wrote, “the IOM identified the imbalance in authority between the Office of New Drugs and the Office of Surveillance and Epidemilogy (formerly the Office of Drug Safety) as a major weakness in the drug safety system. In an effort to facilitate a collaborative and constructive team approach, the IOM recommended joint authority for the Office of New Drugs and Office of Surveillance and Epidemiology in the post-approval setting.”