WASHINGTON — A Food and Drug Administration official on Monday gave more clues for how the agency plans to wield new authority to make drug companies enroll post-market clinical trials before granting speedy drug approvals.
That new power is part of reforms to the FDA’s accelerated approval path that Congress recently passed. Accelerated approvals allow the agency to provide fast access to drugs for serious and life-threatening diseases by approving them based on test results that predict clinical outcomes.
Companies must prove drugs work by continuing to test them post-approval, but it sometimes takes longer than FDA would like for companies to finish those confirmatory trials. It can be difficult to get patients to enroll in clinical trials once a drug is for sale, so one way to get post-approval trials done faster is to require them to be enrolled before approval. FDA cancer drug regulators wrote in a New England Journal of Medicine paper last October that it typically took 3 ½ years longer to withdraw drugs that didn’t work out when confirmatory trials were not underway at the time of approval.
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