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...
