Vioxx
Recall News
In response to the Vioxx controversy
, FDA asks Congress for ability to require drug label changes
March 1, 2005
After serious Vioxx side effects were discovered, safety warnings were delayed reaching the public because the FDA and manufacturer Merck & Co. had to negotiate what the warning should say.
In response to the Vioxx controversy, the FDA asked Congress on Tuesday for authority to dictate label changes for drugs to end the back and forth with pharmaceutical companies that delayed warnings to Vioxx users about potential risks. The FDA's deputy director for new drugs told the Senate Committee on Health, Education, Labor and Pensions that the Vioxx safety warning lapse was the result of negotiating “how the specific language should be worded.”
It can take a very long time to agree on the wording of a safety warning, and with Vioxx, it took more than a year. Merck rejected several FDA proposals and the FDA rejected many of Merck's.
New Vioxx warnings were added to labels in 2002, but Vioxx was eventually pulled from the market in September 2004 after more research linked the drug to heart attacks and stroke. An FDA advisory panel decided February 18 that COX-2 inhibitors, including Vioxx and Pfizer Inc.'s Celebrex and Bextra, had benefits outweighing the risks of heart attacks and strokes, but suggested the arthritis drugs include strong warnings.
The FDA has been under fire in recent years after a series of safety concerns involving drugs already on the market. Congress is currently considering legislation to tighten rules on how the government keeps track of drugs following FDA approval.
Last month, the Bush administration announced it will set up an independent Drug Safety Oversight Board to monitor FDA approved medicines once they have entered the market and update physicians and patients with surfacing risk and benefit drug information.
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