Has the FDA dropped the ball with accelerated approval of drugs? Elizabeth Tracey reports

August 30, 2021

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The Alzheimer’s drug Aduhelm is just the latest misstep in the FDA’s mishandling of accelerated approval, with a recent study showing that almost half of drugs approved this way haven’t done the required confirmatory studies. Caleb Alexander, an internal medicine expert at Johns Hopkins and member of the panel recommending against Aduhelm’s approval, says reform is possible.

Alexander: When products are approved under accelerated review some have suggested that reimbursement for them be diminished so that the company has an economic incentive to complete the studies that we’re all waiting for. So one model might allow for or stipulate that manufacturers are only going to be paid a very modest amount for their product until the evidence is in as to whether or not it actually is safe and effective.  :28

Alexander doesn’t think scrapping accelerated approval entirely is the answer. At Johns Hopkins, I’m Elizabeth Tracey.

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