An Abdication of FDA's Core Mission

Statement

An Abdication of FDA's Core Mission

Congresswoman Rosa L. DeLauro (Conn.-3) issued the following statements amid reports that the Food and Drug Administration could have saved 22,000 lives had the agency removed the heart surgery drug Trasylol from the market two years ago, when a study revealed widespread death associated with it.

Additionally, DeLauro announced that the Agriculture - FDA Appropriations Subcommittee will hold an oversight hearing on drug safety when Congress returns on Wednesday, February 27, 2008.

"FDA's failure to remove the heart surgery drug Trasylol after a study linked the drug to kidney failure and increased patient deaths is shocking, and appears to be a clear abdication of FDA's core responsibility - ensuring the safety of drugs and protecting patients. Given that it has been estimated that 22,000 deaths could have been prevented if Trasylol had been removed from the market quicker, it will be difficult for the American consumer to maintain confidence in the FDA when its foundation has been shattered.

"Another extremely disturbing aspect of this case is the allegation that Bayer withheld data confirming the results of this study. If proven true, this raises serious questions about corporate governance and our current drug safety system. The influence of the drug industry within the FDA has been allowed to proliferate for far too long. It is time to restore the agency's mission of ensuring the safety of the products it regulates.

"I look forward to viewing the details contained in the 60 Minutes report and intend to address this issue during an oversight hearing on drug safety, which I will convene the last week of February."

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