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Watchdog Takes Up Review on Controversial Alzheimer’s Drug Approval

The FDA commissioner requested the investigation.

The inspector general at the Health and Human Services Department said on Wednesday her office would review the approval process for an Alzheimer’s drug that has been the subject of controversy. 

Acting Food and Drug Administration Commissioner Dr. Janet Woodcock requested the review in a letter to the acting HHS inspector general on July 9. Her request followed several controversies surrounding the review process for Biogen’s drug Aduhelm, which the FDA approved on June 7. This was the Food and Drug Administration's first approval of an Alzheimer’s treatment since 2003. The drug was given “accelerated approval” for an unmet medical need against the advice of medical experts and FDA’s own advisory committee in November. 

“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 said there were concerns about communications “outside the formal correspondence process.” 

“We are committed to overseeing the integrity of FDA’s drug approval process, including the decisions informing how some drugs are selected for the accelerated approval pathway,” said Tesia Williams, HHS IG spokeswoman, in a statement. “Our planned work takes into consideration the concerns raised by stakeholders about FDA’s approval of the Alzheimer’s treatment drug Aduhelm.” 

The IG’s assessment will “determine if the application of FDA’s pertinent policies and procedures allow for inappropriate relationships with pharmaceutical officials and other external entities,” Williams continued. “We are confident our findings and recommendations will provide meaningful information to stakeholders and promote optimal program administration at FDA.”

The HHS IG’s announcement said the office won’t “assess the scientific appropriateness of the FDA's approval of any of the drugs under review.” It expects to release the results in fiscal 2023, potentially through multiple reports. 

Woodcock said in a tweet the FDA will fully cooperate with the IG’s investigation and “welcomes the opportunity to provide clarity regarding the science-based application of the accelerated approval pathway.” 

A Biogen spokesperson told Government Executive in a statement on Wednesday afternoon, "We are aware of the [Office of Inspector General] review and we will cooperate."

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. 

In wake of the FDA’s approval of Aduhelm, three advisory committee members resigned. The day before Woodcock sent the letter, the FDA limited its recommendation on who should receive the drug. 

Update: This article has been updated with comment from Biogen.

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