DELAURO RESPONDS TO AVANDIA RESTRICTIONS

Washington, DC— Congresswoman Rosa L. DeLauro (CT-3), Ranking Member on the Labor, Education, Health, and Human Services Appropriations Subcommittee, issued the followings statement today in reaction to the announcement by the Food and Drug Administration (FDA) that the controversial diabetes drug Avandia will be severely restricted and available only through a special program.

As former chairwoman of the Agriculture-FDA Appropriations Subcommittee, Congresswoman DeLauro fought to increase funding for the FDA and to strengthen its enforcement of drug safety, and repeatedly called for the FDA to remove the drug from the market.

"I am pleased with the FDA's actions in implementing critical restrictions on the use of Avandia recommended more than 8 months ago by an FDA advisory committee—today's action will effectively take this dangerous drug off the market. But this is not entirely good news. It reaffirms the need for a strong and independent post-market surveillance office at the FDA to protect American consumers. It is clear to me that the data does not support the widespread use of this drug and that the public has been at risk of heart attacks and other unnecessary effects from this unsafe drug.

"And while GlaxoSmithKline's role in getting their drug approved for use played a role in this process, the fault does not lie entirely with the company. The FDA must prevent unsafe drugs from being approved and must act quickly and decisively when evidence shows a drug to be unsafe. I will continue to fight to provide the FDA with the necessary funding to strengthen its oversight and enforcement of drug approval and post-market surveillance, including oversight of clinical trials, and to fulfill its responsibility of protecting the American consumer."