FDA acting commissioner seeks review of controversial Alzheimer’s drug approval
pharmafile | July 12, 2021 | News story | Sales and Marketing |
The FDA’s acting commissioner Janet Woodcock is asking for a federal investigation of doctors within her own agency who met with the makers of Biogen’s Alzheimer’s drug before the medicine’s recent approval.
This is a highly unusual step by the agency, and follows the intense controversy surrounding the drug approval.
In a letter on 9 July, Woodcock asked the Health and Human Services Inspector General to review interactions between Biogen executives and agency officials during the review process, and to determine whether those contacts violated FDA rules.
She wrote: “There continue to be concerns raised regarding contacts between representatives from Biogen and the FDA during the review process, including some that may have occurred outside of the formal correspondence process.”
“To the extent these concerns could undermine the public’s confidence in the FDA’s decision, I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General.
The HHS inspector general is an independent office of the health department, which houses the FDA, and has powers to subpoena and probe possible violations of law or policy.
Dana Conti, a spokesman for Biogen, said the company “will, of course, cooperate with any inquiry in connection with a possible review of the regulatory process.”
On Thursday, Biogen narrowed its advice on who should be given the drug, recommending it only be used in patients with mild cognitive impairment or dementia.
The inspector general’s findings are likely to lead to recommendations for FDA management. They could potentially also lead to discipline for some staffers.
If any wrongdoing is suspected, the inspector general can potentially refer the matter for possible prosecution to the Justice Department.
Aduhelm is priced at $56,000 per year and many experts doubt whether the drug works at all.
The FDA panel members were unanimous in their decision to not approve the drug, but it was approved regardless. Three of the FDA advisers who opposed the drug resigned over the decision.