Beyond Aduhelm: OIG Review Will Put FDA’s Entire Accelerated Approval Program Under Microscope

HHS Inspector General’s timeline means Congress won’t have findings to use during upcoming user fee renewal debate; ‘review’ is not an ‘investigation’ which could come with potentially more damning legal consequences for the agency.

FDA under OIG microscope (design by Nielsen Hobbs) — HHS OIG announced on 4 August a broad review of FDA's accelerated approval program • Source: Nielsen Hobbs

The US Health and Human Services Office of Inspector General will undertake a broad assessment of how the Food and Drug Administration implements the accelerated approval pathway, following concerns of inappropriate agency actions during the review and approval of Biogen, Inc.’s Alzheimer’s treatment Aduhelm (aducanumab-avwa), but the fiscal year 2023 expected issue date of the review could make any recommendations fall a bit flat.

That’s because Congress will need to reauthorize the agency’s prescription drug user fee program by 30 September 2022, the most...