Aduhelm Approval Prompts Backlash, Could Bring Investigation

Aduhelm (aducanumab), the Biogen Inc. Alzheimer’s drug recently approved by the FDA, seems less and less likely to be dispensed to patients, as prominent providers, practitioner groups and experts have all publicly argued against doing so. Several health insurers have said they will not pay for the drug unless patients pass strict prior authorization standards — and the FDA approval itself could be in jeopardy as the agency’s acting commissioner has called for the HHS Office of Inspector General (OIG) to investigate the process that led to the approval.

FDA Acting Commissioner Janet Woodcock, M.D., on July 9 asked the OIG to investigate the approval process for Aduhelm. (Woodcock was not involved in the decision to approve the drug.)

In a letter to OIG that Woodcock published on Twitter, she wrote that she had “tremendous confidence” in the agency staff who made the decision, but that “there continue to be concerns raised…regarding contacts between representatives from Biogen and FDA during the review process.”

Raja Sekaran, a partner of Nossaman LLP and former senior council at HHS OIG, says he expects OIG will take a look at the Aduhelm process.

© 2021 MMIT

Peter Johnson

Peter has been a reporter for nearly a decade. Before joining AIS Health, Peter covered a wide variety of topics in his hometown of Seattle, where he continues to live. Peter’s work has appeared in publications including The Atlantic and The Stranger. Peter attended Colby College.

Related Posts
September 23

Experts: EU Will Continue to Beat US on Biosimilar Adoption

Read More
September 23

Pharma Industry Braces as Dems Hash Out Drug Price Package

Read More
September 23

Study Flags Potential Benefit of Targeted Medication Reviews

Read More


Sign up for publications to get unmatched business intelligence delivered to your inbox.

subscribe today