DeLauro on FDA and EU Decision to Severely Restrict Avandia

Washington, DC – Congresswoman Rosa L. DeLauro (CT-3), Chairwoman of the FDA and Agriculture Appropriations Subcommittee, issued the following statement today in reaction to the U.S. Food and Drug Administration and the European Medicines Agency to severely restrict access to the controversial diabetes drug Avandia.

The drug will be suspended completely from the European market, but still available to patients in the United States who attest, along with their doctors, that they have tried all other medications and that they are aware of the drug's dangers.

"While I am disappointed that Avandia was not withdrawn from the market, this decision to severely limit its use is a significant step forward. I have repeatedly urged the FDA to remove this drug from the market until its potential dangers could be evaluated, and for the GlaxoSmithKline trials to be independently verified. Today's joint announcements from the FDA and EMA reflect just how serious this situation is, and justifies the fears about this drug's possible impacts.

"These announcements are by no means a reason to celebrate—too many lives are at risk. I am pleased that Avandia will no longer be widely prescribed in the United States, and that the FDA has taken steps to severely restrict access to the drug. However, given how long the process took to act, I hope that the FDA fulfills its mission of protecting the American public and examines how the regulatory process could be reformed to prevent another Avandia from endangering lives."