STAT+: Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals

Key senators want to create a council meant to help the FDA sidestep some of the issues that plagued its approval of the Alzheimer’s drug Aduhelm.

WASHINGTON — The Senate is taking pains to avoid another Aduhelm controversy.

In new bipartisan legislation unveiled on Friday, senators included language that would create a “coordinating council” meant to ensure officials across the entire Food and Drug Administration stay in sync when considering medicines under the controversial accelerated approval pathway.

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