FDA Seeks Investigation Over Approval of Alzheimer’s Drug, Aduhelm
FDA’s acting commissioner requested a federal investigation into interactions between Biogen and FDA staff during the approval process of its Alzheimer’s drug.
Source: FDA Official
By - FDA has called for a government investigation into the approval of Biogen’s Alzheimer’s drug, Aduhelm, according to multiple news sources.
Experts recently discovered an unreported meeting in May 2019 between a top Biogen executive and the FDA's lead reviewer for Alzheimer's drugs. The meeting came after Biogen pulled Aduhelm after trials showed it might not have much of an effect.
FDA interactions with drug industry staff are controlled and carefully documented, so it is unclear if the meeting violated agency rules.
In a letter to the Office of Inspector General (OIG) at HHS, Janet Woodcock, MD, acting commissioner of FDA, requested that OIG conduct an independent review of interactions between Biogen and FDA during the process that led to Aduhelm’s approval.
“There continue to be concerns raised regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the formal correspondence process,” Woodcock said in a letter to the OIG.
“It is critical that the events at issue be reviewed by an independent body such as the Office of Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” Woodcock continued.
Ultimately, the 2019 collaboration led to the drug's approval at the beginning of June 2021.
But when Biogen and FDA brought the drug before the FDA's panel of outside advisers in November 2020, 10 of the 11 committee members voted that there was not enough evidence to show Aduhelm could slow cognitive decline, recommending against its approval.
Joel Perlmutter, MD, a Washington University neurologist; David Knopman, MD, Mayo Clinic neurologist, panel member, and investigator in clinical trials of Aduhelm; and Aaron Kesselheim, MD, professor at Harvard Medical School, all resigned following FDA’s approval of Aduhelm.
The trio claimed the federal agency did not gather enough proof that the drug will help Alzheimer’s patients and said that approving a drug that is not effective will set Alzheimer’s research back.
In the recent letter, Woodcock said she had “tremendous confidence in the integrity” of the FDA staff and that it was “critical that an independent body review the events at issue.”
