FDA investigates controversial Alzheimer’s drug approval

Will It or Won’t It?

Acting Commissioner Janet Woodcock, who heads the U.S. Food and Drug Administration (FDA) has requested a federal investigation into the approval of Aduhelm, Biogen’s treatment for Alzheimer’s disease, a month after a decision that upset lawmakers, doctors and public health advocates. That prompted calls for an OIG investigation from advocacy groups, former federal health officials and members of Congress.

Woodcock asked the independent Office of Inspector General to probe the way in which FDA staff interacted with Biogen prior to the drug’s June 7 approval. STAT reported that FDA officials worked hand in hand with Biogen executives to get the drug on the market, including an off-the-books meeting and an unprecedented decision to approve Aduhelm through a regulatory shortcut.

According to Woodcock, “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. To the extent these concerns could undermine the public’s confidence in FDA’s decision, I believe 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. I have tremendous confidence in the integrity of the staff and leadership of the Center for Drug Evaluation and Research involved in the aducanumab review and their commitment to unbiased and science-based decision-making.”

As STAT reported, “Inspector general investigations are among the most serious types of civil investigations that can be conducted into a federal agency. The inspector general’s office typically has broad power to subpoena internal FDA documents and to conduct interviews under oath. The OIG can also refer potential criminal violations to the Department of Justice. However, no allegations of criminal conduct have been made against the FDA. It is rare for the OIG to investigate the FDA, and even more exceptional for it to investigate an individual drug approval decision, according to STAT’s review of public records. The inspector general is currently reviewing a number of FDA programs, like its systems for monitoring the safety of medical devices, though the majority of those inquiries are audits and evaluations, less serious forms of investigations.”

Gregg Gonsalves, a professor at Yale School of Public Health who has been sharply critical of Aduhelm’s approval, said, “There should be an investigation, and it should be broad-based and not limited in scope to the improper relationships between the FDA and Biogen. We need to know in greater detail about how the decision-making was done within the agency, because it was such a departure from normal procedure.”

Meanwhile, Biopharma Dive reported that the Centers for Medicare and Medicaid Services will begin a National Coverage Determination process for “monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease,” a class of drugs that includes Aduhelm and other experimental drugs in development. The agency initiated a 30-day comment period July 12 and will hold two listening sessions in July to hear public input, after which it will decide whether a national coverage policy is necessary.

The Alzheimer's Association wants the Centers for Medicare and Medicaid Services to issue a nationwide coverage policy for Biogen's new drug Aduhelm to prevent "barriers to appropriate and equitable access." The request was issued shortly after the FDA narrowed its guidance for those eligible for treatment.

Insurers want a single Medicare coverage policy, called a National Coverage Determination, to set guidelines on reimbursement. Biogen said that Aduhelm would cost $56,000 per year, which could increase Medicare drug spending by tens of billions of dollars annually. Biogen and the FDA have been under fire about the contradictory data surrounding the drug's approval.