Congress faults US regulator’s approval of Biogen Alzheimer’s drug

Two US congressional committees have accused the Food and Drug Administration of inappropriately collaborating with Biogen before approving the company’s Alzheimer’s drug.

A joint report by the House committees on Oversight and Reform, and Energy and Commerce accused the FDA of granting Aduhelm, Biogen’s Alzheimer’s drug, accelerated approval in 2021 despite an internal advisory committee’s refusal to issue a favourable recommendation, and concerns about the drug’s inconsistent clinical data.

The report published on Thursday also accused the regulator of failing to record critical meetings with Biogen and of improperly collaborating with the company on a joint briefing that was later presented to an important FDA advisory committee.

The findings of the 18-month investigation deal another blow to Biogen’s treatment for a disease that affects tens of millions of people worldwide. In April, the agency that controls spending by government-funded health schemes in the US limited reimbursement for Aduhelm to just a few thousand patients enrolled in clinical trials rather than the estimated 6mn Alzheimer’s patients in the US.

“This report documents the atypical FDA review process and corporate greed that preceded FDA’s controversial decision to grant accelerated approval to Aduhelm,” Frank Pallone, Energy and Commerce committee chair, said in a statement.

Carolyn Maloney, Oversight and Reform committee chair, added: “I am hopeful these findings are a wake-up call for FDA to reform its practices and a call to action to my congressional colleagues to continue oversight of the pharmaceutical industry to ensure they don’t put profits over patients.” 

Biogen in a statement said it “stands by the integrity of the actions we have taken”.

The company and the FDA said they had co-operated with the congressional panels. They highlighted part of an FDA review that was cited in the findings that said there was “no evidence” that interactions between the agency and Biogen “were anything but appropriate”. 

The review, however, also said the collaboration between the agency and the pharmaceutical company “exceeded the norm in some respects” and that the joint briefing document “was not an appropriate approach”.

The FDA in a statement said the agency’s job entailed “frequently interact[ing]” with companies to acquire information for regulatory decisions, but added it had “started implementing changes consistent with the Committee’s recommendations”.

The committees said Biogen and the FDA held at least 115 meetings in the 12 months to July 2020, but that the total number of interactions in this period is unknown as the agency lacked a “real record” of informal meetings and other gatherings.

The panels also accused the company of originally setting an “unjustifiably high price” for Aduhelm at $56,000 per year, disregarding how this would affect Alzheimer’s sufferers and the Medicare scheme. Biogen later dropped the price to $28,200, according to the report.