July 27,2007

Sen. Grassley calls on the FDA to allow scientific opinion and dissent at Monday meeting on Avandia

WASHINGTON – Sen. Chuck Grassley wants to make sure that FDA scientists can speak freely about any concerns they may have regarding the diabetes drug Avandia during a meeting planned for Monday to discuss cardiovascular risks associated with the drug.

He also has called on the FDA Commissioner to address possible problems with this meeting being organized by FDA officials responsible for approving new drugs instead of FDA officials responsible for assessing the safety of drugs after they’re on the market. Grassley specifically raised concerns regarding potential conflicts of interest with one of the speakers at the meeting and some of the meeting’s voting members.

This morning the New York Times ran a story about a new report from federal drug reviewers indicating that patients who take Avandia face an increased risk of heart attacks compared to those taking a similiar drug.

Grassley has questioned the FDA’s delayed response to this and other risk information and asked the Commissioner to account for allegations that two senior FDA scientists were taken off work on Avandia after raising concerns about the drug’s safety.

Overall, strengthening the FDA Office of Surveillance and Epidemiology has been a central focus of Grassley’s efforts to fix problems at the FDA.

In January, he 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. In May, Grassley offered an amendment to the Food and Drug Administration Revitalization Act of 2007 that 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. The amendment was defeated by only one vote.

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 has revealed instances where agency leaders suppressed scientific dissent regarding agency actions and drug-safety recommendations.

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