By Rigby Sampson
On Friday 9th July, Janet Woodcock the Acting Commissioner of the FDA (and former Director of the Centre for Drug Evaluation and Research (CDER) announced there would be an investigation into the FDA’s Accelerated Approval process, that led to the approval of the new Alzheimer’s drug Aduhelm (Aducanumab).
The investigation, headed by the inspector general for the Department of Health and Human Services, is intended to clear the air around what many deem to be a highly controversial decision. This comes in the wake of the House Democrats investigation into the approval and pricing of Aduhelm, and the call for the Finance Committee Chair to hold a hearing on the matter.
Regardless of the outcome, this will likely set precedent for future medications using the Accelerated Approval pathway.