The Food and Drug Administration’s controversial approval of a questionable Alzheimer’s drug caused another hit on Thursday as congressional investigators called the process ” full of anomalies.”
The 18-month investigation by two House committees detailed “atypical cooperation” between FDA regulators and a company the agency oversees—the manufacturer Biogen production by Aduhelm. The investigation also cited Biogen documents stating that the company intended to “make history” by setting what investigators called an “unreasonably high” initial price of $56,000 a year. year for this drug.
The criticisms come as the FDA is expected to decide whether to approve another new Alzheimer’s drug in January. Thursday’s report called for the agency to “act quickly” to ensure that any future approvals of Alzheimer’s disease are not met with “the same doubts about the truthfulness of the review.” by the FDA.”
The FDA and Biogen issued statements Thursday defending the Aduhelm approval process.
In 2021, the FDA overruled its independent scientific advisors to approve Aduhelm even though studies have failed to prove it actually helps patients. Biogen halted two studies after disappointing results showed the drug did not slow the inevitable worsening of Alzheimer’s – only to later claim that a new analysis of one study showed found higher doses to provide additional benefit.
The FDA argues that the drug’s ability to reduce the hallmark of Alzheimer’s disease, a buildup of plaque in the brain, suggests it has the potential to slow the disease. The backlash was immediate when three FDA advisers resigned in protest and the then-head of the agency called for an internal investigation. In the end, Medicare refused to pay for the drug — even after the annual price was dropped to $28,000 — unless patients signed up for a clinical trial to prove whether it actually slowed the progression of the disease. cognitive decline or not.
Thursday’s report said the FDA and Biogen were involved in a large number of phone calls, meetings and emails, some of which were not properly documented. In addition, regulators and companies spent months working together to prepare a summary document for FDA advisors that did not adequately represent the substantial disagreement within the FDA regarding the how to handle Aduhelm, the report said.
The investigators recommend that the FDA take steps to restore trust in the approval process, including properly documenting interactions with drug manufacturers. They also urge manufacturers to consider advice from patient groups and other outside experts on fair drug pricing.
In a statement Thursday, the FDA said Aduhelm’s decision was “based on our scientific assessment of the data” and the agency’s own internal review that found its interactions with Biogen to be appropriate. . But it said it plans to update its guidance on drug development for Alzheimer’s disease and will review the findings of the investigation.
In its own statement, Biogen said: “Alzheimer’s is a very complex disease and we’ve learned from the development and launch of Aduhelm” but it “stands with the integrity of the actions it takes” We have done it.”
