Report: FDA fails to follow-up on unproven drugs

By: WASHINGTON (AP)
By: WASHINGTON (AP)

Congressional investigators say 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.

Today's report 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 says 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. The agency says that "Millions of patients with serious or life-threatening illnesses have had earlier access to new safe and effective treatments" thanks to the program.


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