The Food and Drug Administration’s 2021 approval of Biogen’s anti-amyloid antibody aducanumab, coming after a negative assessment from an advisory committee, sparked intense controversy. Now the U.S. House of Representatives has weighed in, finding that the FDA broke some of its own protocols in how it handled Biogen’s application. A 45-page report jointly issued by the Committee on Energy and Commerce and the Committee on Oversight and Reform spelled out numerous breaches of standard practice, including the FDA working too closely with Biogen, not documenting many of those interactions, and ignoring dissenting opinions from its own statistical division. The report was widely covered in the media (The New York Times; The Washington Post; STAT news).
- U.S. House report finds fault with FDA’s process for Aduhelm approval.
- The agency failed to document numerous interactions with drug sponsor Biogen.
- It worked too closely with Biogen and ignored dissenting opinions within the FDA.
It is unclear if the report will result in any action being taken. A separate investigation by the Department of Health and Human Service’s inspector general into how the FDA handles accelerated approvals is still ongoing (Aug 2021 news).
The House report was the result of an 18-month investigation that examined more than half a million documents, including internal Biogen briefings and an FDA review of its own dealings with Biogen. The report details several problems, such as the failure to record every interaction between the agency and drug sponsor. The House committees found evidence for at least 66 undocumented phone calls and email exchanges between them, as well as an unknown number of informal, off-the-books meetings.
In addition, the report accuses the FDA of sidelining the opinions of its own statistical division, which had found flaws in Biogen’s data. Meanwhile, the FDA’s neuroscience division collaborated with Biogen on its AdComs presentation, an unusual move employed only nine times before in the agency’s history, each time for cancer drugs. Together, this approach resulted in conflicting AdComs talks, with the FDA seemingly at odds with itself (Nov 2020 news).
The House report also faulted the FDA for pushing Biogen to accept a broad label for aducanumab’s use. Internal Biogen documents showed the company had doubts about this, but did not voice them until widespread public outcry forced its hand a month after aducanumab’s approval. Biogen then requested and received a narrower label that matched the population in the clinical trials (Endpoints News).
Finally, the House committees hammered Biogen on pricing, citing internal company documents that showed it chose its initial $56,000 price point to maximize profits, trying for a blockbuster drug launch that would make history.
For its part, Biogen released a statement defending its decisions. “Biogen stands by the integrity of the actions we have taken,” the company wrote.
The House recommended three changes to prevent similar problems from occurring in the future. It asked the FDA to develop policies regarding when to write joint reports with sponsors, to improve its process for documenting communications with them, and to update its guidance for industry on Alzheimer’s drugs. The internal FDA review, completed in May 2021, made similar suggestions. The agency told the House it is still working on implementing those changes.—Madolyn Bowman Rogers