Bloomberg Law
March 7, 2022, 10:06 PM

House Bill Strengthens FDA’s Power Over Fast Drug Approvals

Jeannie Baumann
Jeannie Baumann

The FDA could more easily pull drugs that show no clinical benefit off the market under a bill that aims to revamp the approval process used for Biogen Inc.’s Alzheimer’s drug.

The measure, introduced Monday by House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) would make changes to the accelerated approval process, a Food and Drug Administration regulatory mechanism designed to speed up access to game-changing medications for patients with unmet medical needs.

The FDA has faced criticism that it’s speeding up approvals without certainty that the drug will show a definitive clinical benefit down the line—particularly ...

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