July 30,2007

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Sen. Grassley’s comment on the FDA advisory committee meeting regarding Avandia

Sen. Chuck Grassley issued the comment below about the FDA advisory board meeting today regarding the diabetes drug Avandia. Sen. Grassley is Ranking Member of the Committee on Finance and has sought legislative and administrative reforms to strengthen the FDA’s post- market surveillance of pharmaceuticals.

Grassley Comment:

“It’s good to see that scientists participating in the meeting today were able to hear from a range of views within the Food and Drug Administration, and that both the Office of New Drugs and the Office of Surveillance and Epidemiology were represented. As a result, the meeting considered the full deck instead of a stacked deck.”

Background Information:

In January, Sen. 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. In May, Sen. 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.

Sen. 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. Sen. 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.