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0902 BtS15 Regulatory Rheostats

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Regulatory rheostats key to meeting promise of expedited approvals

Better mechanisms are needed to dial in appropriate access based on postmarket evidence

Better mechanisms are needed to dial in appropriate access based on postmarket evidence.

Mounting frustration with the accelerated approval process, brought to the public’s attention by the controversial decision on Biogen’s Aduhelm, is sparking debates inside and outside FDA about ways to improve the pathway. The discussions include proposals to put more flexibility into systems for adjusting access to drugs based on evidence collected after approval.

Ideally, regulatory rheostats would allow FDA to modify access to medicines approved through its accelerated pathway, with a range of options from redefining the patient population who can receive them to withdrawing approval altogether.

There is broad agreement that it’s in the best interests of patients and public health to protect the benefits of accelerated approval. But there’s increasing pressure to address limitations that have at times put the agency, drug companies and patients into conflict over the fate of drugs approved through the pathway that have not yet demonstrated clinical benefit.

With a historically high number of products awaiting confirmatory data — about 60% of pending approvals have been granted since 2019 — the accelerated pathway will likely remain a focus for disagreements. 

While Aduhelm aducanumab-avwa from Biogen Inc. (NASDAQ:BIIB) and Eisai Co. Ltd. (Tokyo:4523) is the current flashpoint, recent controversies with PD-1 inhibitors approved under the pathway have also elicited public concerns from FDA officials.

Commercial and political realities make it difficult for officials at FDA to make even crude adjustments to access, such as

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