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Archive for Monday, October 26, 2009

Report: No follow-up on unproven drugs

October 26, 2009

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— 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, say congressional investigators.

A report due out today from the Government Accountability Office also shows that the FDA has never pulled a drug off the market due to a lack of required follow-up about its actual benefits — even when such information is more than a decade overdue.

When pressed about that policy, agency officials said they have no plans to get more aggressive.

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 so-called “accelerated approval” program, which is only used to approve drugs for the most serious diseases.

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