- The Food and Drug Administration’s controversial 2021 approval of Biogen’s Alzheimer’s disease drug Aduhelm was “rife with irregularities,” congressional investigators concluded in a report published Thursday. Among the irregularities were an undetermined number of meetings the regulator didn’t record in accordance with its own protocols.
- According to the report, FDA reviewers abruptly changed course to grant accelerated approval of Aduhelm on a “substantially abbreviated timeline,” after negative feedback from within the agency over a full approval based on Aduhelm’s clinical benefits, which were in question.
- The report’s release comes days before an FDA deadline to decide on accelerated approval of another Alzheimer’s drug, called lecanemab and developed by Eisai and Biogen. It also coincides with President Joe Biden’s signing of a federal spending bill that would, in some ways, tighten the FDA’s accelerated approval rules.
The controversy over the Aduhelm approval — described by one outside FDA expert as “probably the worst drug approval decision in recent U.S. history” — continues to weigh on the FDA’s reputation nearly two years later.
The report issued Thursday, which was prepared by investigators from the House Oversight and Reform and Energy and Commerce Committees, adds new findings to probes conducted by the agency’s own staff as well as the Department of Health and Human Services’ inspector general.
Investigators documented 115 meetings, calls and extensive email exchanges over a one-year period, from July 2019 to July 2020, after Biogen and FDA reviewers convened a working group to review Aduhelm data and guide its potential approval. The total number is “unknown” because the FDA didn’t have a “clear record” of interactions, the investigators said.
In another unusual step, the materials presented to a panel of outside experts didn’t include documents drafted separately by Biogen and the FDA, but rather a single collaborative briefing. This type of presentation was itself unusual, the investigators state, because when that process has been used previously it was for “oncological drugs under circumstances of broad consensus.”
Moreover, at least one section attributed to Biogen was drafted by the FDA, while sections presented as objective responses from agency reviewers was drafted by the same working group.
The report recommends the FDA ensure all meetings between staff and drugmakers are properly recorded. It also urges the agency to develop a formal protocol for joint briefing documents as recommended by its internal review, and that it update its guidelines for Alzheimer’s disease drug development.
In an email, the FDA said its own internal review had found the contact between Biogen and FDA staff was “appropriate” and that it has started implementing the recommended changes on joint briefing documents and Alzheimer’s guidelines.
About a third of the report focuses on actions taken by Biogen in preparation for marketing Aduhelm, detailing the internal process that led it to set an initial price of $56,000 per year. Documents reviewed by the committee indicated the company knew its price would meet substantial resistance and weigh heavily on Medicare’s budget, but chose to “maximize revenue” instead.
Biogen prepared an outreach campaign that was intended to counterbalance the expected pushback, and was prepared to several billion dollars on sales and marketing between 2020 and 2024, the report found.
After backlash to the $56,000 price tag, Biogen later lowered Aduhelm’s price before eventually withdrawing marketing support for the drug in the face of sustained resistance from doctors and insurers. Sales of Aduhelm from its June 2021 approval through Sept. 30 totaled just $7.5 million, a far cry from Biogen’s anticipation of a blockbuster launch.
In a statement, Biogen said it “stands by the integrity of the actions we have taken.”