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Two strong congressional committees investigating the controversial federal approval of Biogen’s Alzheimer’s drug Aduhelm requested extensive information and documentation from the Food and Drug Administration in a letter released Thursday, making it clear that committee leaders were annoyed by the unusual actions the agency took. during the evaluation and approval of the drug.

“We are concerned about the apparent anomalies in the FDA’s processes surrounding the Aduhelm review,” the committee chairs said in a 13-page letter. asking for lots of documents and answers to questions.

“Despite concerns expressed by experts, including the agency’s own staff, the FDA has granted expedited approval for the drug,” and members of the independent advisory committee said in the letter.

“We are also concerned about reports of unusual coordination between the FDA and Biogen throughout the drug’s approval process,” the committee said.

The acting commissioner of the FDA, Dr. The letter, addressed to Janet Woodcock and signed by Representative Carolyn Maloney, chair of the House Oversight and Reform Committee, and Representative Frank Pallone, chair of the House Energy and Commerce Committee, seeks information on: Virtually every aspect of the FDA’s handling of the aducanumab brand Aduhelm my name.

citation details First reported in a New York Times investigation in JulyTwo months before the drug was given the green light in June, a council of top FDA officials “concluded that further clinical research is necessary before the drug is approved,” the letter said, and one member said that approval “could result in millions of patients taking the drug.” without any indication that aducanumab is actually doing any benefit or worse harming.””

Approval of Aduhelm, a treatment that requires monthly intravenous infusions, which Biogen priced at $56,000 per year, was met with a major firestorm. criticism from many Alzheimer’s experts and other scientists.

While some Alzheimer’s experts support approval given that there is little therapy for this devastating condition, many are concerned that the evidence has not convincingly shown that the drug may offer any benefit. There is also concern that the drug may cause brain swelling or cerebral hemorrhage.

The Congress letter also includes a former Biogen senior medical director, Dr. Vissia Viglietta also has objections to the drug’s approval. HE He told The Times in July He said the approval “beats everything I believe scientifically and reduces the rigor of regulatory agencies.”

Several major medical centers have ruled since approval, including the Cleveland Clinic, the Mount Sinai Health System in New York City, and Providence, a major Washington State-based healthcare system. Not offering Aduhelm to patients.

And the Department of Veterans Affairs has decided not to include the drug in its formulary, this improvement was first reported by. Endpoint NewsA spokesperson for the VA quoted that the decision was made “because of the risk of significant adverse drug events and the lack of evidence of a positive effect on cognition.”

The letter from the committees was received on July 23, a few days after The Times investigation was published, by Dr. He says leaders of Woodcock and the agency’s Center for Drug Evaluation and Research briefed congressional staff and materials, including the minutes of the council meeting. Quoted in The Times article.

“This information was helpful, but important questions remained,” the letter said.

In a response to the letter, the FDA said it would work with Congress to respond to requests for documents and information. Also, in July, Dr. It was noted that Woodcock urged the Office of the Inspector General of the Department of Health and Human Services to investigate interactions between Biogen and agency officials.

“The FDA recognizes the need for new therapies and has used a science-based approach that takes patient perspectives into account when evaluating the benefits and risks of this therapy,” the statement said.

The debate about aducanumab began when two nearly identical late-stage clinical trials of the drug were closed in 2019, as an independent monitoring committee concluded that the drug was not helping patients.

A subsequent analysis by Biogen found that participants who received the highest dose of aducanumab in one trial experienced a very slight slowdown in cognitive decline, but participants in the other trial experienced no benefit.

The committees’ letter includes several questions about FDAs. Close cooperation with Biogen Since then, it has included a joint Biogen-FDA presentation to an advisory committee of independent experts along with several meetings per week in the summer of 2019 to jointly evaluate the data and chart the path to approval.

The letter also seeks information regarding an internal review the FDA is conducting this year to evaluate its cooperation with Biogen. First reported by The Times. Committees are also seeking information on any meeting between Biogen officials and FDA officials that has not been formally documented by minutes or other memos.

“FDA officials claimed at a staff briefing on July 23, 2021 that it may be common for some of this communication to take place as an informal discussion between the FDA and the drug sponsor,” the letter said.

“However, FDA officials also acknowledged at the staff briefing that not all communications with Biogen officials were memorialized, in violation of FDA best practices.”

The FDA has previously said it “often works closely with industry”, especially when “there is a significant need for treatments for devastating diseases.”

Dr. Woodcock publicly acknowledged “process problems” but did not explain what those problems were.

The letter also asks whether FDA officials have participated in projects or conference presentations with Biogen officials while the company has pending drug approval applications before the FDA.

While aducanumab is in clinical trials, the director of the FDA office reviewing Alzheimer’s drugs, Dr. Billy Dunn and Samantha Budd Haeberlein, who oversaw the drug’s clinical development for Biogen, reportedly worked together on several other projects, including conference presentations. .

Commissions were sent in July. A letter to Biogen To request documents and information about Aduhelm. When asked to comment on the investigation and the letter sent to the FDA, Biogen said on Thursday: “We continue to cooperate with the committees’ investigation and produce documents in response to committees’ requests.”

“Biogen stands 100 percent behind Aduhelm and the clinical data that support its endorsement,” said Biogen in written responses to questions from The Times in July.

Announcing its approval in June of Aduhelm, the first new drug for Alzheimer’s in 18 years, the FDA acknowledged that there was insufficient evidence that the drug would help patients.

Instead, the agency said it gave the green light to Aduhelm under a program called “accelerated approval,” which allows drugs to be authorized without convincing evidence of benefit if it aims to treat serious illness with several treatment options and if the drug is affecting some of the disease. biology (known as a biomarker) in a way that is “reasonably likely to predict clinical benefit”.

The reason the agency announced — the drug reduces a key protein that builds up on plaque in the brains of people with Alzheimer’s — was that the agency official leading the aducanumab review said at an earlier public meeting that it wouldn’t be used.

Many Alzheimer’s experts say there’s not nearly enough evidence that reducing the protein amyloid slows the progression of memory and thinking problems.

The letter from congressional committees raises detailed questions about why the agency decided on expedited approval and why it didn’t return to the council of senior officials or an advisory committee of independent experts after it decided to seriously consider that option in April. to ask their opinion.

In November 2020, the independent advisory committee was asked to consider only standard approval, and voted overwhelmingly He said the evidence is not enough to show that the drug works. Three members of this committee resigned in protest in June after the drug was approved.

The letter also asks for documents related to the drug labeling process. The label was widely criticized because initially the drug could be given to anyone with Alzheimer’s, and the agency said it could be given within a month of approval. sharply narrowed He advised and said that only patients in the milder stages of the disease should take it.

“Aduhelm’s approval has far-reaching implications not only for individuals with Alzheimer’s, but also for the elderly, federal health programs, and future research, development, and approval of drugs for Alzheimer’s and other diseases,” the letter said. and people of color are disproportionately affected by Alzheimer’s.

“To help ensure that the American public continues to have the highest level of confidence in the FDA and in the safety and efficacy of approved drugs, and to help inform future legislation, we need more information about the FDA’s review and approval process for Aduhelm,” the letter states. said. ”