According to a congressional investigation, the FDA process for approving the Alzheimer's drug Aduhelm was rife with irregularity. The agency's actions raise serious concerns about F.D.A.'s failure to follow protocol.
The investigation was started after the F.D.A. approved the drug. The company set a high price for Aduhelm because it wanted to establish it as one of the top pharmaceutical launches of all time.
According to the investigation, Biogen was prepared to spend up to several billion dollars on aggressive marketing to counter the expected backlash over Aduhelm's price. According to the report, the campaign would target doctors, patients, advocacy groups, insurers, policymakers and communities of color who were underrepresented in the clinical trials of the drug.
The F.D.A. is considering two other Alzheimer's drugs, one of which was developed by Biogen. The agency must take swift action to make sure that its processes for reviewing future Alzheimer's disease treatments don't lead to the same doubts about the integrity of F.D.A.'s review.
The reportdocuments the atypical F.D.A. review process and corporate greed that preceded F.D.A.'s controversial decision to grant accelerated approval to Aduhelm.
The House Committee on Oversight and Reform was chaired by a democrat. She hoped the report would be a wake-up call for F.D.A. to reform its practices and for Congress to continue oversight of the pharmaceutical industry.
The F.D.A. said that they cooperated with the committees and continued to review their findings.
The agency was supposed to interact with companies to get accurate information. It is in the best interests of patients that we will continue to do so. Changes consistent with the committee's recommendations have already been implemented.
The company said it stood by the integrity of its actions. We have learned from the launch of Aduhelm thatAlzheimer's is a very complex disease.
Many Alzheimer's experts were upset by Aduhelm's approval. The Department of Veterans Affairs and the Cleveland Clinic decided not to offer Aduhelm due to the risks of brain swelling and bleeding. After Medicare limited its coverage of Aduhelm, the drug was removed from the marketplace.
The New York Times first reported on the internal inquiry of the F.D.A. in 2021. The agency's self-examination, conducted shortly before Aduhelm was approved, was less negative than the congressional findings, but identified similar issues.
The internal inquiry found that the Aduhelm evaluation did not pay enough attention to the views of the agency's own statistical team. Team members were not allowed to participate in some deliberations after expressing their reservations.
In a highly unusual move, the F.D.A. and Biogen collaborated to produce a presentation for the agency's independent advisory committee. At least one point attributed to Biogen was actually written by the F.D.A., according to the congressional investigation.
The lack of a unified F.D.A. perspective on the data was one of the reasons why the use of the joint briefing document was not an appropriate approach.
Both the congressional investigation and the F.D.A. inquiry found that the agency did not record many interactions with Biogen. It met with Biogen multiple times to analyze data from one trial that failed and another trial that seemed to work, helping advise on whether the company should seek approval.
There were at least 52 meetings over the course of a year, but not all of them were documented. There was no official memorialization of 66 calls or substantive email exchanges. The internal inquiry of the F.D.A. did not show a clear record of the number of interactions between the agency and Biogen.
The internal inquiry of the F.D.A. said there was no evidence that its interactions with Biogen were anything but appropriate, but it did issue four recommendations to prevent future issues. More than a year later, the F.D.A. still hasn't implemented them.
A congressional report questioned the F.D.A.'s decision to give the drug a special designation. The agency had said Aduhelm would only be considered for traditional approval.
According to the report, the change came after a council of senior agency officials met to review Aduhelm and agreed there wasn't enough evidence that it worked. One member of the council warned that approval could result in millions of patients taking aducanumab without any indication of receiving any benefit, or worse, and that another trial should be conducted first.
Three weeks after that meeting, the F.D.A. told Biogen it was considering Aduhelm for accelerated approval, which would allow approval of drugs with uncertain benefit if they can treat serious diseases with few other options. The F.D.A. gave Biogen more than eight years to complete the trial, which allowed Aduhelm to be given to patients.
The agency said that Aduhelm targets the amyloid in the brain of Alzheimer's patients. Years of data did not show that amyloid reduction slowed cognitive decline.
According to the congressional report, the agency did not reconstitute an independent advisory committee or an internal group of experts to consider accelerated approval. The agency said that the standard for accelerated approval had not been met for Alzheimer's drugs. The F.D.A. said in its statement on Thursday that it plans to update the guidance it issued last year.
The initial decision by the F.D.A. to approve Aduhelm for all Alzheimer's patients was brought up in the report. F.D.A. officials told the committees that the broad label would have benefits, such as allowing patients to continue on Aduhelm after their disease gets worse.
The report found that the advisers for Biogen warned against allowing Aduhelm for all Alzheimer's patients.
The report said that the Alzheimer's disease team leaders were concerned that the company could lose credibility if they advocated for a broad label. A consultant who interviewed doctors, patient advocates and insurers warned that it would likely be giving false hope to patients desperate for anything that might slow the progression of the disease.
The F.D.A. suggested that Biogen accept it. There is no plan for Biogen to push back on broad label indication. The F.D.A. immediately narrowed the label after public confusion and criticism.
According to the report, Biogen set a high price for Aduhelm because they wanted to make history. The report said that Biogen developed an external narrative about the drug's value to sell.
An extensive media campaign directed at patients was planned by Biogen that would involve connecting more than 50 journalists with medical experts supportive of the drug.
Proper documentation of its interactions with drug companies and clear protocols for when it can create joint presentations should be adopted immediately by the F.D.A. The report recommended that Biogen and other companies communicate safety and efficacy concerns to the F.D.A., and consider the actual value of a drug when setting prices.
For assurance on the safety and efficacy of the medications they take, the American people rely on F.D.A., and it is incumbent upon drug companies such as Biogen to ensure that the well-being and safety of patients are prioritized.
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