As US House Changes Hands, CMS May Face More Oversight Than FDA
Key Republican committee chairs on health issues are familiar faces, largely supportive of the US FDA’s approach to drug regulation. Implementation of the new pricing law, however, will get a lot more scrutiny.
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FDA is formally asking Congress to weigh in on the best approach to regulate CBD in consumer products. That provides another target for legislative attention that may mean that FDA’s core drug regulatory activities stay comfortably out of the spotlight.
A Congressional report on the US FDA approval of Biogen/Eisai’s Aduhelm generated another round of negative headlines for the agency – and rubbed salt in the wounds of a commercial disaster for the sponsors. But it probably could not have turned out better for FDA and the drug review climate overall.
US FDA’s Post-Aduhelm Reforms Include Updated Alzheimer’s Development Guidance, Record-Keeping On Sponsor Meetings
Agency already had an action plan in hand to address concerns with the aducanumab review even before the controversial approval, but it has not been fully implemented yet. A House committee report is another nudge.