May 09,2007

Grassley wins Senate passage of amendment to strengthen new FDA authority

WASHINGTON — Sen. Chuck Grassley today won an important victory in his crusade to improve the work of the Food and Drug Administration in monitoring the safety of FDA-approved drugs and devices.

Senators voted 64 to 30 for his amendment to increase the civil monetary penalties contained in the Food and Drug Administration Revitalization Act of 2007. The penalties would apply to companies that fail to comply with FDA directives that include label changes, post-approval studies, and communicating information about newly identified drug risks.

“The civil monetary penalties that were in the bill didn’t pack enough punch to get the attention of corporations,” Grassley said. “By approving my amendment today, senators recognized that it doesn’t do much good to give the FDA new kinds of authority if the penalties designed to enforce that authority aren’t meaningful.”

Grassley’s legislation increases the minimum civil monetary penalty from $10,000 to $250,000 that can be imposed on a drug maker that is knowingly out of compliance. It also says that the amount of the penalty will double for every 30-day period of non-compliance after that and up to $2 million. Previously, the overall bill capped the penalty at $1 million.

“These penalties need to be more than just an insignificant cost of doing business in order to affect behavior,” Grassley said.

Attached in pdf is the language of Grassley’s amendment no. 998, which was cosponsored by Sens. Christopher Dodd of Connecticut, Olympia Snowe of Maine, and Jeff Bingaman of New Mexico.

Grassley offered a second amendment today which was narrowly defeated 47 to 46. This measure 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 the amendment was fundamental to reforming and improving the FDA’s performance and 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 an article published in last week’s Journal of the American Medical Association, Grassley’s arguments for the two offices carrying equal weight on post-market matters were echoed by two members of the Institute of Medicine committee that evaluated FDA’s drug safety system. The authors 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.”

“Defeat of this amendment is a lost opportunity when it comes to improving drug safety for American consumers,” Grassley said. “The amendment responded directly to well-documented problems and expert advice on how to address those problems. Congress won’t be acting responsibly if we don’t continue working to strengthen post-market surveillance by the FDA.”

The prestigious Institute of Medicine of the National Academies issued a report on its assessment of the nation’s drug-safety system last fall. The Institute said the FDA had systemic problems and needed to exercise more vigilance over the life-cycle of drugs and provide more information to the public about drug risks. Grassley said this review validated concerns expressed by the watchdog community and added muscle to the reform effort. Last spring, the Government Accountability Office issued a separate report that said improvement was needed in the FDA’s post-market decision making and oversight process.

Grassley has conducted active oversight of the FDA for the last three years and has put pressure on the drug safety agency to act with more independence and transparency in order to restore public confidence and strengthen public safety especially when it comes to drugs already on the market. Grassley 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.

In January, Grassley and Sen. Christopher Dodd introduced for the second time two bills to revamp and prioritize the post-market surveillance process within the FDA and to greatly expand public access to information about all clinical trials through a registry and results database. Their bills are S.468, the Food and Drug Administration Safety Act of 2007, and S.467, the Fair Access to Clinical Trials Act of 2007.

The FDA Revitalization Act on the Senate floor this week is S.1082. It would reauthorize the FDA’s user fee authority, which collects money from drug and device companies for review of their products. The House of Representatives is expected to consider its versions of the drug safety and user fee reauthorization bills in the coming weeks.

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