Monday, April 24, 2006

FDA - more teeth, less bark, please

The FDA should have the power to require that drug makers conduct studies on the safety of prescription medications already on the market, congressional investigators recommend.

Drug makers often promise timely follow-up studies, but they often delay going ahead, the agency said.

The FDA recently reported that of 1,231 studies that companies pledged to conduct, often in exchange for expedited approval of a drug, nearly two-thirds had yet to get under way as of last Sept. 30.

The FDA would have ``real teeth'' if it had the recommended authority, Sen. Charles Grassley said.

As a result of these Big Pharma delays , the FDA can lack useful data in determining whether an approved drug really is safe, according to a report being released Monday by the Government Accountability Office.

GAO's examiners studied the agency's handling of four controversial drugs -- the cholesterol-lowering drug Baycol, the painkiller Bextra, the rheumatoid arthritis drug Arava, and the nighttime heartburn medication Propulsid -- and concluded that "there is a lack of criteria for determining what safety actions to take and when to take them."

All but Arava were ultimately taken off the market because of safety concerns, but the GAO found that disputes between two arms of the FDA's Center for Drug Evaluation and Research slowed the process.

Since 2000, 10 drugs have been withdrawn by their manufacturers for safety reasons.

The report found that the Office of Drug Safety, which monitors reports of emerging safety risks, at times made recommendations that were ignored by the larger and more influential Office of New Drugs.

The GAO also criticized the way experts in the Office of Drug Safety were kept from speaking at important advisory committee meetings on drugs they were studying. The drug safety office has seen considerable turnover, with eight directors in the past 10 years.

globegazette.com

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