Accelerated Approval

August 9, 2021

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Do medicines approved by the FDA on their accelerated pathway ever get confirmed? Elizabeth Tracey reports

When the FDA developed its accelerated pathway to drug approval in 1992, it seemed like a good way to get drugs to the market faster and help more people. Now a study in the BMJ shows that of 253 drugs approved this way, 112 have not been confirmed as safe and effective. Caleb Alexander, an internal medicine expert at Johns Hopkins and a member of an FDA committee, comments.

Alexander: Manufacturers are required to complete confirmatory trials for products approved under the accelerated pathway but all too often these trials aren’t completed until years later, if at all. And when they are completed they may still really fail to put the scientific issues to rest. Endpoints that are selected are sometimes the same surrogate endpoints that were used to gain approval. Sometimes it’s another surrogate endpoint, but not the hard clinical outcomes that we all care about.  :33

Alexander says the latest debacle over Aduhelm points to the need to overhaul this regulatory pathway. At Johns Hopkins, I’m Elizabeth Tracey.

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