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Accelerated Approval Drugs and Devices Often Fall Short of FDA Standards

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FDA’s Accelerated Approval program was intended to allow drugs and medical devices that treat serious conditions to be approved earlier to fill an urgent, unmet medical need. However, two new reports published August 15 in the Journal of the American Medical Association (JAMA) have found that accelerated approval is often granted without clear evidence of safety and effectiveness.

One report, compiled by Dr. Huseyin Naci of the London School of Economics and Political Science, analyzed the FDA’s accelerated approval of 22 drugs for 24 medical conditions. For standard approval, the FDA typically mandates high level randomized controlled trials (RCTs) that show a drug’s safety and effectiveness. However, 14 of the accelerated approvals reviewed were based wholly on less rigorous testing standards.

Lower Standards for Approval?

Because of the lower standard for approval, the FDA required 38 more trials after approval to verify the benefit of the medications, but three years after accelerated approval, only 19 trials had been completed, 11 were underway, six were delayed by more than a year, and two had been discontinued entirely. Ten approvals eventually met the requirements set forth by the FDA, one to five years after accelerated approval.

A second report published in JAMA came to a similar conclusion regarding accelerated approval of medical devices, finding that relatively few studies were randomized, meaning that it is not known if the device is actually superior to an alternative treatment, or even better than no treatment at all.

The results of these two studies seems to emphasize that patients should ask their doctors about the evidence for drugs and devices that are being prescribed before they use them, according to Dr. Robert M. Califf of Duke University School of Medicine, who wrote an editorial that accompanied the reports.

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