A congressional investigation found that the US Food and Drug Administration’s “atypical collaboration” to approve a high-priced Alzheimer’s drug was “rife with irregularities.”
The report, released Thursday, was the result of an 18-month investigation by two House committees. It is sharply critical of Biogen, maker of the medication Aduhelm.
The report says Biogen set an “unjustifiably high price” for Aduhelm to “make history” for the company, and thought of the drug as an “unprecedented financial opportunity.” Biogen priced Aduhelm at $56,000 per year, even though its actual effects on patients were unknown.
The company, the investigation found, planned an aggressive marketing campaign to launch the drug, intending to spend more than $3.3 billion on sales and marketing between 2020 and 2024 – more than 2½ times what it spent to develop Aduhelm.
The Committee on Oversight and Reform and the Committee on Energy and Commerce found that the collaboration between the FDA and Biogen in the approval process of the drug “exceeded the norm in some respects,” including not completely documenting how often FDA representatives met with the company.
The FDA also approved the drug for “people with Alzheimer’s disease,” a far broader population than was studied in Biogen’s clinical trials.
Internal documents from the company said that Biogen accepted this broader indication “despite internal reservations about the lack of evidence of clinical benefit for patients at disease stages outside of the clinical trials and an unknown safety profile,” the report says. Leaders expressed concern that the company could lose credibility, and it developed a communications strategy to deal with the “anticipated fallout,” the report says.
The committees recommended that the FDA document all of its meetings with drug sponsors, establish a protocol for briefing documents and advisory committees, and update its guidance for how Alzheimer’s drugs are developed and reviewed.
The committees also recommended that companies clearly communicate safety and efficacy concerns to the FDA and consider the value assessments made by outside experts when setting drug prices.
“The American people rely on FDA for assurance on the safety and efficacy of the medications they take. The number of patients and families impacted by Alzheimer’s disease will continue to increase, and it is crucial that FDA and drug companies adhere to established procedures and conduct themselves with the transparency necessary to earn public trust,” the report says.
The FDA said in a statement that its “decision to approve Aduhelm was based on our scientific evaluation of the data contained in the application, which is described in the approval materials.”
The agency says it is reviewing the committees’ findings and recommendations and says its own review found that the interactions with Biogen were appropriate.
“It is the agency’s job to frequently interact with companies in order to ensure that we have adequate information to inform our regulatory decision-making. We will continue to do so, as it is in the best interest of patients. That said, the agency has already started implementing changes consistent with the Committee’s recommendations.”