Two powerful congressional committees investigating the controversial federal approval of Biogen’s Alzheimer’s drug Aduhelm requested extensive information and documents from the Food and Drug Administration in a letter published Thursday, which made it clear that committee leaders are concerned about unusual actions taken by the agency as part of the evaluation and approval of the drug.
“We are concerned about apparent anomalies in the FDA’s processes related to the review of Aduhelm,” said committee chairs in a 13-page letter requesting a range of documents and answers to questions.
“The FDA granted expedited approval to the drug despite concerns raised by experts – including the agency’s own staff,” and members of its independent advisory committee, the letter said.
“We are also concerned about reports of unusual coordination between the FDA and Biogen during the drug’s approval process,” the committee added.
The letter – addressed to the Acting Commissioner of the FDA, Dr. Janet Woodcock, and signed by Rep. Carolyn Maloney, Chair of the House Oversight and Reform Committee, and Frank Pallone, Chair of the House Energy and Trade Committee, asked for information on virtually every step of the FDA’s handling of Aduhelm, the Brand names for aducanumab.
Citing details first reported in an investigation to the New York Times in July, the letter notes that two months before the drug was given the go-ahead in June, a council of senior FDA officials “concluded” that another clinical study was needed before the drug was approved “. Approval could result in millions of patients taking aducanumab with no indication that they could actually get any benefit or, worse, cause harm. “
The approval of Aduhelm – a treatment that requires monthly intravenous fluids priced at $ 56,000 a year for Biogen – received a firestorm of criticism from many Alzheimer’s experts and other scientists.
While some Alzheimer’s experts backed the approval because there are so few therapies for the devastating disease, many are concerned that the evidence is inconclusive that the drug may be of any benefit. There is also concern because the drug can cause brain swelling or bleeding.
The letter from Congress also raised objections to Dr. Led by Vissia Viglietta, former senior medical director of Biogen, who helped develop Aduhelm’s late-stage clinical trials. She told the Times in July that the permit “defeats everything I believe in scientifically and lowers the harshness of regulators.”
Since approval, some major medical centers – including the Cleveland Clinic, the Mount Sinai Health System in New York City, and Providence, a major healthcare system based in Washington state – have decided not to offer Aduhelm to patients.
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And the Department of Veterans Affairs has decided not to include the drug in its prescription, a development first reported by Endpoints News, which quoted a VA spokesman as saying the decision was “due to the risk of significant adverse drug events and the.” “There has been a lack of evidence of a positive impact on cognition.”
The committees’ letter states that Dr. Woodcock and the directors of the Agency’s Drug Evaluation and Research Center on July 23, several days after the Times published the investigation, provided a briefing and materials to Congressional staff, including minutes of the council meeting, cited in The Times article.
“This information was helpful, but important questions remain,” the letter said.
In a statement in response to the letter, the FDA said it would work with Congress to respond to requests for documents and information. It also stated that Dr. Woodcock in July asked the Inspector General of the Department of Health and Human Services to conduct an investigation into the interactions between Biogen and agency officials.
“The FDA recognizes the need for new therapies and has used a science-based approach that takes into account the patient perspective in evaluating the benefits and risks of this therapy,” the statement said.
The controversy over aducanumab began when two near-identical clinical trials of the late-stage drug were discontinued in 2019 because an independent monitoring committee concluded that the drug did not appear to be helping patients.
A later analysis by Biogen found that participants who received the highest dose of aducanumab in one study had a very slight slowdown in cognitive decline, but participants in the other study did not benefit from it at all.
The committees’ letter includes several questions about the FDA’s close collaboration with Biogen since that time, including several meetings per week in the summer of 2019 to jointly evaluate the data and plan a path to approval, as well as a joint presentation by Biogen and the FDA before an advisory body of independent experts.
The letter also asks for information on an internal review the FDA conducted earlier this year to evaluate its collaboration with Biogen, an investigation first reported in the Times. The committees are also looking for information about meetings between Biogen officials and FDA officials that have not been formally documented with minutes or other notes.
“FDA officials alleged during the staff briefing on July 23, 2021 that it may also be common for some of this communication to take place as an informal discussion between the FDA and the drug sponsor,” the letter reads.
“However, FDA officials also confirmed in the staff meeting that not all communications with Biogen officials were memorable, contrary to FDA best practices.”
The FDA previously said that 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 describe what those problems were.
The letter also asked if FDA officials participated in projects or conference presentations with Biogen officials while the company was filing drug applications with the FDA
The Times reported that Dr. Billy Dunn, director of the FDA’s Alzheimer’s Drug Review Office, and Samantha Budd Haeberlein, who oversaw the drug’s clinical development for Biogen, worked together on several other projects, including conference presentations, during aducanumab’s clinical trials.
In July, the committees sent a letter to Biogen asking for documents and information on Aduhelm. When asked to comment on the investigation and the letter to the FDA, Biogen said in a statement Thursday, “We are continuing to work with the committees ‘investigations and are preparing documents in response to the committees’ inquiries.”
In written responses to the Times’ questions in July, Biogen said, “Biogen is 100 percent behind Aduhelm and the clinical data supporting its approval.”
When the FDA announced the approval of Aduhelm – the first new drug for Alzheimer’s disease in 18 years – in June there was insufficient evidence that the drug would help patients.
Instead, the agency said it is giving Aduhelm the go-ahead under a program called “accelerated approval” that allows drugs to be approved without convincing evidence, when they’re intended to treat serious illnesses with few treatment options, and when the drug affects part of the disease Biology (known as biomarkers) in a way that “has a reasonable likelihood of predicting clinical benefit”.
The reason the agency cited – that the drug reduced a key protein that clumped together in plaques in the brains of people with Alzheimer’s – is one that the agency official who led the aducanumab review didn’t in an earlier public meeting had used.
Many Alzheimer’s experts say there isn’t nearly enough evidence that reducing the protein amyloid slows the progression of memory and thinking problems.
The letter from the congressional committees asks detailed questions about why the agency opted for expedited approval and why, after deciding in April to seriously consider that option, it no longer referred to the senior officials’ council or advisory committee independent experts returned to ask their opinion.
In November 2020, the independent advisory committee had been asked to consider only the standard approval and voted overwhelmingly that the evidence was insufficient to show that the drug works. Three members of that committee resigned in protest in June after the drug was approved.
The letter also requests documents relating to the procedure for deciding on the label of the medicinal product. The label was widely criticized for initially saying the drug could be given to anyone with Alzheimer’s disease, and a month after approval, the agency severely narrowed its recommendation, saying that only patients with mild stages of the disease should be given it.
“The approval of Aduhelm has far-reaching implications, not only for people with Alzheimer’s disease, but also for seniors, government health programs and future research, development and approval of drugs against Alzheimer’s and other diseases,” says the letter, and people of color are disproportionate affected by Alzheimer’s.
“To ensure that the American people continue to have the greatest confidence in the FDA and the safety and efficacy of approved drugs,” the letter added, “and to keep future legislation informed, we need more information about the FDA’s process for review and review.” Approval by Aduhelm. “
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