US Senate Advances its Version of Accelerated Approval Reforms

May 31, 2022

Right on the heels of similar legislation in the US House of Representatives, the Senate is pushing forward its version of accelerated approval pathway reforms. The reforms are attached to the FDA user fee legislation which, if not ratified by September, will force the agency to lay off its employees. The reforms from both the House and the Senate would make ongoing confirmatory trials a prerequisite for moving forward on accelerated approvals.

According to Zachary Brennan of Endpoints News, “The new move comes in response to a select number of high-profile cases where the FDA didn’t consult their own adcomm on an accelerated approval but granted one anyways (e.g. Biogen’s Alzheimer’s drug Aduhelm) or where sponsors win accelerated approvals but then drag their feet on the confirmatory trials (e.g. Sarepta) or never run them at all (e.g. Secura Bio). The bills would also create expedited procedures for FDA to withdraw an accelerated approval when a confirmatory trial fails, which it’s currently dealing with in the case of Makena.”

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(Source: Endpoints News, May 27th, 2022)

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