FDA Asks for IG Review on Alzheimer’s Drug Approval Process 

The head of the Food and Drug Administration asked the agency’s watchdog on Friday to determine if any interactions between a biotechnology company and FDA officials were inappropriate in the review process for an Alzheimer’s drug that has been the subject of controversy. 

Acting FDA Commissioner Dr. Janet Woodcock sent a letter to the acting Health and Human Services Department inspector general following several controversies surrounding the review process for Biogen’s drug Aduhelm that was approved on June 7. This was FDA's first approval for an Alzheimer’s treatment since 2003. The drug was given “accelerated approval,” which is expedited approval for an unmet medical need, against advice from FDA’s own advisory committee in November and other medical experts. 

“As you know there has been significant attention and controversy surrounding the process for review for Biogen’s biologics license application,” which “includes an ongoing focus on interactions between Biogen and [FDA] staff during the review process,” Woodcock wrote. Therefore, she asked for an independent review of the interactions between agency and Biogen staff during the process “to determine whether any of those interactions were inconsistent with FDA policies and procedures.” 

Woodcock said she has great confidence in the “integrity of the staff and leadership” at the agency’s Center for Drug Evaluation and Research that were involved; however, she noted there have been concerns raised about communications that possibly happened “outside the formal correspondence process.” She said the agency will fully cooperate should the IG take up the probe, which she said she would like to happen “as soon as possible.” 

HHS IG Spokesperson Tesia Williams said in a statement, “We received the letter and are reviewing it for appropriate action. We do not have any further comments at this time.” 

A Biogen spokesperson said, “We will, of course, cooperate with any inquiry in connection with a possible review of the regulatory process.”

According to Stat News, it’s “rare” for an IG to probe the FDA and even more so for it to look at a specific drug approval. 

“Earlier calls for an OIG investigation have focused on the close relationship between Billy Dunn, head of the FDA’s neuroscience division, and Biogen executives,” said Stat’s report. “Biogen had an off-the-books meeting with Dunn in May 2019, enlisting his support for the treatment that would become Aduhelm. A month later, Dunn and his FDA colleagues proposed using a regulatory shortcut called accelerated approval to get the drug approved, contradicting the agency’s claim that it raised that option only this past March. The FDA was so supportive of Aduhelm that, even in 2019, some inside Biogen believed its approval was inevitable.” 

The letter comes a day after the FDA limited its recommendation on who should receive the drug. “This is a welcome step and addresses one of many problems with this drug approval,” tweeted Dr. Aaron Kesselheim, professor of medicine at Harvard Medical School. “But the FDA/Biogen should be doing much more now to help patients by actively combatting misperceptions about this drug.” He was one of three advisory committee members to resign in wake of the FDA’s approval of Aduhelm. 

Last month, the top lawmakers on the House Oversight and Reform Committee and Energy and Commerce Committee launched an investigation into the approval as well as the pricing of the drug.

“We have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical benefit,” they said in a statement on June 25. “We strongly support innovative treatments to help the millions of Americans who suffer from Alzheimer’s disease, but Aduhelm’s approval and its $56,000 annual price tag will have broader implications for seniors, providers and taxpayers that warrant close examination.”