HHS Watchdog Will Investigate How FDA Doles Out Accelerated Approvals

HHS has announced that its Office of the Inspector General is beginning an investigation into how the FDA determines who gets an accelerated approval pathway and how those prized designations are implemented.

The notice announcing the examination came after nearly two months of controversy over the FDA’s June 7 decision to grant accelerated approval to Biogen Alzheimer’s disease drug Aduhelm (aducanumab) even though the $56,000-per-year therapy showed only moderate benefit in one phase 3 trial based on surrogate endpoints and no benefit in another.

The FDA’s approval of Aduhelm “raised concerns due to alleged scientific disputes within the FDA, the advisory committee’s vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA’s use of the accelerated approval pathway,” HHS said.