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US FDA’s Most Controversial Drug Approval Decisions, From A To Z

Executive Summary

With action imminent on Biogen’s Alzheimer’s drug aducanumab, the Pink Sheet looks back at 10 of FDA’s most controversial drug approval decisions, from Addyi to Zohydro.

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The Case For US FDA To Be More Political In Its Approval Decisions

No one thinks it is a good idea for the US FDA Commissioner or some other higher up political actor to decide when and if to approve new drug applications. But it might not be so bad if the scientific staff at FDA paid a bit more attention to ‘political’ issues before making some decisions.

Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial

Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.

Patient Support May Have Helped Push Aduhelm Toward Approval

After largely negative advisory committee meeting, a patient group held a listening session with the FDA to be sure their voices were heard during the review of Biogen's aducanumab.

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