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Congress Must Act Quickly to Address Growing Crisis At the Food and Drug Administration

Feb. 27, 2008  

Congress Must Act Quickly to Address Growing Crisis At the Food and Drug Administration

Public Citizen’s Sidney M. Wolfe, M.D., Testifies Before House Subcommittee

WASHINGTON, D.C. – The Food and Drug Administration (FDA) is suffering from a crisis in leadership, a lack of congressional oversight and a dangerous reliance on the pharmaceutical industry to bankroll its operations, Sidney M. Wolfe, M.D., director of the Health Research Group at Public Citizen told a House of Representatives subcommittee this morning.

While these problems have existed for years, they have become glaringly obvious in recent weeks with news stories about deaths linked to drugs such as the anticoagulant heparin, which is made in China, and Trasylol, a drug that reduces bleeding during surgery and may be responsible for thousands of deaths a year.

“The situation at the FDA has never been worse than now,” Wolfe said. “Congress must act quickly to restore confidence in the FDA by removing the considerable influence of the drug industry, which currently funds almost two-thirds of the FDA’s budget for drug approval.”

Wolfe testified before the House Agriculture-FDA Appropriations Subcommittee’s hearing on FDA drug safety.

Since 2002, the FDA’s budget for foreign inspections of drug facilities has decreased 25 percent. This comes at the same time as the number of foreign plants manufacturing drugs for import into the U.S. has rapidly increased, Wolfe said.

While Chinese laboratories account for 22 percent of the foreign facilities that import into the U.S., they were subject to only 4 percent of the FDA inspections last year, Wolfe said.

READ Wolfe’s testimony.