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Republicans Plan Own Bill to Revamp Speedy Drug Approvals (1)

March 8, 2022, 10:14 PMUpdated: March 8, 2022, 11:25 PM

House Energy and Commerce Republicans plan to counter a proposal by Democrats to revamp an FDA approval pathway that Biogen Inc.'s Alzheimer’s drug has thrust under the microscope.

The draft bill, obtained by Bloomberg Law and confirmed by a Republican aide on Tuesday, would overhaul the accelerated approval process that’s designed to speed up access to medicines by relying on laboratory markers that can predict a drug’s clinical benefit. The bill, by Rep. Cathy McMorris Rodgers (R-Wash.), the top Republican on the committee, would allow the FDA to expedite withdrawals of drugs that ultimately don’t show a benefit to ...