Thursday, May 31, 2007

FDA Reform In Light of Recent Drug Safety Issues

Article in the New York Times -- F.D.A. Still Unsettled in Wake of New Questions, by Gardiner Harris.  Here's an excerpt:

When Dr. Andrew C. von Eschenbach took over the Food and Drug Administration in 2005, the agency had a crisis over drug approvals that had missed or ignored dangerous side effects in Vioxx, antidepressants and other prominent medications.

Dr. von Eschenbach promised improvements, and agency officials said they would no longer be caught flatfooted on drug safety.

But this month, The New England Journal of Medicine published a study suggesting that a major diabetes pill, Avandia, might increase the risk of heart attacks.

Concerns over that drug and others have led Republicans and Democrats in the House and the Senate to call for investigations. A House hearing is planned for June 6.

Dr. von Eschenbach said in a briefing on Wednesday that his agency needed to collaborate more closely with drug companies.

BGS

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