NEWS RELEASE

Committee on Energy and Commerce
Rep. John D. Dingell, Chairman

Dingell, Stupak Respond to FDA’s Announcement on Heparin

Washington, D.C. – Reps. John D. Dingell (D-MI), the Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations, today released the following statement in response to the Food and Drug Administration’s announcement on the contaminated Heparin supply.

“The current regulatory system is woefully insufficient, a fact that has been proven by the tragedies caused by unsafe heparin. It’s clear that FDA does not have the ability to protect the American people from unsafe food and drugs. And it’s unfortunate that the Administration has failed to provide the funding necessary for FDA to do its job,” said Dingell. “Our legislation addresses the need for better information about importers and improved inspections of foreign-made food and drugs. In addition to enhanced safeguards, FDA needs a significant infusion of resources to successfully take on those careless enough, or deceitful enough, to ship contaminated products to our markets.”

“Without an overhaul of our foreign drug inspection procedures, the deaths associated with heparin won’t be the last casualties of contaminated drugs,” Stupak said. “Our proposed import safety legislation gives FDA the resources and guidance needed to hold foreign facilities to the same standard as domestic ones.”

Last Thursday, Dingell and Stupak joined Rep. Frank Pallone, Jr., Chairman of the Subcommittee on Health, in releasing draft legislation designed to ensure the safety of food, drugs, medical devices and cosmetics.

Tomorrow morning at 11:00 a.m., the Subcommittee on Oversight and Investigations will hold a hearing, entitled, “FDA’s Foreign Drug Inspection Program: Weaknesses Place Americans at Risk.” During the hearing, FDA Commissioner von Eschenbach is expected to report on the Agency’s progress since FDA’s Science Advisory board, the Government Accountability Office (GAO), and the Subcommittee all reported concerns about the FDA’s ability to protect Americans from unsafe drugs.

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