Murky documentation of meetings between Biogen and the FDA, plus an "unjustifiably high price" for a drug that lacked clinical data, are at fault for the Adulelm controversy, two House committees said Dec. 29 in a report.
The collaboration between the regulatory agency and the drugmaker were "atypical" and "rife with irregularities," according to the Committees on Oversight and Reform and Energy and Commerce, which examined more than 500,000 documents over 18 months about the controversial Alzheimer's drug approval.
The problematic approval and subsequent launch of Aduhelm (aducanumab) led to insurers, including Medicare, refusing to cover it and the drugmaker CEO's resignation.
In response to the 46-page report, Biogen said it "stands by the integrity of the actions we have taken." The FDA told Becker's it frequently interacts with companies as part of the approval process and said, "We fully cooperated with the Committees' evaluation and we continue to review their findings and recommendations."
Here are the seven findings from the investigation:
1. Biogen and the FDA had at least 40 "working group" meetings that made up an unusual collaboration, while there were dozens of meetings, emails and other exchanges that were not documented.
2. The regulator and the drugmaker "inappropriately" shared a briefing document in which Biogen could "direct guidance from the [FDA] in drafting" its own sections and view the FDA's internal comments.
3. The FDA gave its accelerated approval to Aduhelm "after just three weeks of review" — far faster than its normal speed when deciding whether to grant a drugmaker a traditional or fast-track approval.
4. The FDA approved the drug with a broad label and Biogen accepted it despite concerns surrounding the "lack of evidence of clinical benefit for patients at disease stages outside of the clinical trials and an unknown safety profile." The trial only covered the Alzheimer's stages of mild cognitive impairment and mild dementia.
5. Biogen set forth an "aggressive launch and marketing plans" for the costly treatment. It originally drafted the treatment to cost $56,000 per year as it eyed $18 billion in annual profits.
6. The company knew the price: "Analyses conducted by Biogen estimated that some Medicare patients could face out-of-pocket costs for Aduhelm of up to 20 percent of their income."
7. Biogen planned to spend 2.5 times more on marketing Aduhelm from 2020 to 2024 than its total spending in development costs for the drug between 2007 and its June 2021 approval.