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FDA fails to follow up on expedited drugs

According to a report, the FDA has allowed several drugs to stay on the market even when follow-up data showed they didn't extend patients' lives

The US Food and Drug Administration (FDA) 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 (GAO) has said.

The report shows the FDA has never taken a drug off market due to a lack of additonal evidence about its actual benefits – even when the request is more than 10 years overdue.

The GAO noted that 144 confirmatory post-marketing studies were required by the FDA for the 90 drug applications that were approved by the accelerated process between 1992 and 2008. Of the 144 studies, 64 per cent have been closed while "several of the remaining studies have been classified by [the] FDA as open for an extended period."

It was also found that the FDA never acted on its authority to expedite the withdrawal of any of these drugs from the market if a required confirmatory study was not completed, or if a study failed to confirm a clinical benefit. The GAO said: "Weaknesses in [the] FDA's monitoring and enforcement process hamper its ability to effectively oversee post-marketing studies."

The FDA has been advised to "clarify the conditions under which it would utilise its authority to expedite the withdrawal of drugs under its accelerated approval process." But the agency has said that, given the unique circumstances of individual drugs, it would be difficult if not impossible to draft a standard policy for withdrawals. 

The FDA added that the report paints an overly negative picture of its so-called "accelerated approval" programme, which is only used to approve drugs for the most serious diseases. It also indicated that while it has taken steps to improve its oversight, withdrawing a product would sometimes mean eliminating the only available treatment for a condition.

27th October 2009

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