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

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.

It’s a clear nod to the ongoing imbroglio surrounding Aduhelm, the Alzheimer’s drug that the FDA approved last year despite a near-unanimous rejection by the agency’s scientific advisers. As STAT reported at the time of the approval, even some top agency staffers weren’t aware of how broad an approval the FDA initially granted Aduhelm.

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