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Congress criticizes FDA’s Aduhelm approval as ‘fraught with irregularities’



U.S. health officials approval process for biological Congressional investigators say Inc.’s controversial Alzheimer’s drug. “full of anomalies,” raising serious concerns about flaws in procedures at the agency.

The Food and Drug Administration was unduly cooperative with Biogen while evaluating a drug called Aduhelm, according to a report on the 18-month investigation released Thursday by two House committees, the Director Monitoring and Reform and Energy and Trade.

Aduhelm was removed despite objections from a group of outside medical experts who advised the FDA not to allow the drug to be placed on the market, citing conflicting results from trials about Aduhelm. its effectiveness; three members of that board resigned upon approval. The US Medicare program then heavily restricted payments to Aduhelm and Biogen ceased its marketing efforts.

Aaron Kesselheim, a professor at Harvard Medical School who left the advisory board after Aduhelm’s approval, reportedly “describes an extremely troubling pattern of behavior surrounding the approval of this drug. “The FDA is the world’s most important public health regulator, but taking steps like this damages their own reputation and the trust that patients and doctors have in them. .”

Aduhelm achieve clearance in June 2021 not by showing efficacy against brain wasting, but by its ability to reduce amyloid plaques in the brain, a physical marker associated with the disease. Another experimental drug that reduces amyloid, Eisai Co.’s lecanemab, is being developed in collaboration with Biogen, return positive results in slowing the disease in September.

Interact often

Biogen says it has been committed to the research and development of treatments for Alzheimer’s disease for more than a decade and has stayed true to its actions. The FDA said it remained committed to ensuring the integrity of its approval process and that its internal review found employees’ work with Biogen to be appropriate.

“It is the duty of the agency to regularly interact with companies to ensure that we have enough information to inform our regulatory decision-making process,” the FDA said in a statement. .

Biogen views Aduhelm as an “unprecedented financial opportunity,” according to a congressional report that criticized Biogen for setting an unreasonably high price tag of $56,000 a year for the product. The report said the company developed aggressive marketing and launch plans designed to maximize revenue, despite knowing that the treatment would be expensive for patients and a burden on Medicare.

Biogen has since then cut Aduhelm’s price to $28,200 to reduce patient out-of-pocket costs and reduce the “potential financial impact on the U.S. healthcare system.” However, the decision was made only after public backlash, the report said.

Wide label

The FDA initially approved the treatment with a label allowing it to be used in more Alzheimer’s patients, rather than early-stage patients for which the drug has primarily been studied. Investigators found that even as the company accepted the statement of use more broadly, there were internal concerns about the lack of evidence to back it up. Biogen then only sought to narrow the conditions for use of the drug after public criticism, the report said.

Documents obtained by the congressional committee show that the FDA and Biogen held “at least 115 significant meetings, calls, and email exchanges” over a 12-month period as Biogen worked to complete and submit application form Aduhelm. That could be an omission, as the FDA doesn’t have a clear record of meetings with Biogen.

The FDA has also used a controversial route, known as expedited approval, to evaluate Aduhelm. Critics have said that route allows many drugs to reach the market on dubious databases.

The FDA said it will continue to use the accelerated route when appropriate, as it allows the agency to provide earlier access to serious, life-threatening conditions.

New York Representative Carolyn Maloney, chair of the Oversight and Reform Commission, said in a statement that the report’s findings should serve as “a wake-up call for the FDA to reform its practices.” mine.

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