The Food and Drug Administration on Friday called for a federal investigation into the process that led to the approval of a new drug for Alzheimer’s disease that has sparked harsh criticism from lawmakers and the medical community.
In a letter to the independent office of the Inspector General of the Department of Health, Acting Commissioner of the FDA, Dr. Janet Woodcock, the scrutiny the agency has been through regarding the approval process for the drug known as Aduhelm. She pointed to interactions between representatives from drug developer Biogen and the agency, saying that some “may have occurred outside of the formal correspondence process”.
“To the extent that these concerns could undermine public confidence in the FDA’s decision, I believe it is critical that the disputed events be verified by an independent body,” wrote Dr. Woodcock. She noted that the review should investigate whether communications between agency staff and Biogen representatives violated FDA rules.
The unusual request to examine the decision-making process of one’s own employees for an individual drug approval is likely to exacerbate the controversy surrounding the approval of Aduhelm. The FDA approved the drug a month ago, overcoming stout objections from its own independent advisors who said there wasn’t enough evidence to know if the drug was effective.
After the decision, three of these experts left an FDA advisory panel.
Dr. Woodcock’s request for an investigation came a day after the FDA narrowed its recommendations on who should receive the drug. After initially being recommended for all Alzheimer’s patients, the agency’s new guidelines should only prescribe it to people with mild cognitive problems.
Biogen did not immediately respond to a request for comment.
STAT, the medical news organization, first reported that Dr. Billy Dunn, the agency’s head of neuroscience, in early May 2019 held an off-the-book meeting with a Biogen manager, Dr. Al Sandrock, exit. While it is not uncommon for pharmaceutical company executives to meet frequently with FDA officials, it is uncommon to provide data that would be part of an FDA application outside of a formal framework.
A few months earlier, Biogen had discontinued two late-stage studies of the drug after early analysis found the drug would not prove effective. However, the Biogen researchers who analyzed the data soon concluded that the decision to stop the studies was premature and that the drug might be effective after all.
The meeting between Dr. Dunn and Dr. Sandrock was a first step in resuming the talks that led to approval last month.