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National Briefing / Washington, D.c.

FDA is rebuked on drug follow-up

October 26, 2009|Times Wire Reports

The Food and Drug Administration has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn't extend patients' lives, the Government Accountability Office says.

A GAO report due out today also says the FDA has never pulled a drug off the market because of a lack of required follow-up about its benefits -- even when such information is more than a decade overdue.

The GAO says the FDA should do more to track whether drugs approved based on preliminary results actually have lived up to their promise.

The FDA responded that the report paints an overly negative picture of its "accelerated approval" program, which is used to approve drugs only for the most serious diseases.

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