House investigation faults FDA, Biogen for Alzheimer’s drug approval

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The biotechnology company Biogen and its regulator, the Food and Drug Administration, are seeking internal approval from the company to ensure that the Alzheimer’s drug Aduhelm can be approved quickly and brought to market at a cost. Ignored concerns and cooperated to circumvent the agency’s own written guidance. The House of Representatives has $56,000 a year in patients, according to a scathing report released Thursday by two committees.

The ‘unusual’ partnership that revived Aduhelm three months after Biogen discontinued clinical trials unfolded through at least 115 meetings, phone calls and email exchanges between the company and the FDA during the year , said the Supervisory Reform Commission report. and energy and commerce.

Joint effort will help Biogen draft a document that will be used to brief the FDA’s advisory committee before the FDA’s advisory committee meets to discuss Aduhelm on November 6, 2020 culminated by the staff of the agency who The FDA often follows advisory committee recommendations, but not this time. None of the advisory board members recommended her Aduhelm, so the FDA changed policy and allowed Biogen to move the drug into an accelerated approval process.

The FDA’s proposal led the drug to be used by more than 6 million Alzheimer’s patients in the country, even though it was only tested on people with early-stage Alzheimer’s disease and mild symptoms, according to the report. has been labeled to

“This is the worst decision the FDA has made in half a century,” said Sidney Wolfe, founder of the advocacy group Public Citizen’s Health Research Group. “This was an unprecedented partnership between the company and the FDA.”

“We are cooperating fully with the panel’s evaluation and continue to consider the panel’s findings and recommendations,” the FDA said in a statement to the report. “It is the agency’s job to interact frequently with companies to ensure that regulatory decisions are well informed. , the authorities have already begun implementing changes in line with the Commission’s recommendations.”

The agency had previously conducted an internal investigation into its handling of Aduhelm and said more than a year ago that the deal between the company and the regulator was “out of the norm” although the partnership was “out of the norm in some respects.” It concluded that there was “no evidence” that it was “abnormal”. Appropriate. “

An internal report said the decision to work “actively” with Biogen was due to a “great unmet medical need” for the treatment of Alzheimer’s disease and that one of Aduhelm’s studies was a “home run when it comes to safety and efficacy.” is.

A report by two House committees also said Biogen knew its initial $56,000 annual price (which was cut to $28,000 in January 2022) would put the company at a great cost to patients. condemned. But the Cambridge, Massachusetts-based company estimates the treatment could bring in as much as $18 billion in annual revenue for Biogen, and a slide to its board of directors said in his presentation: I was there. [the drug] As one of the greatest drug launches of all time. ”

In fact, Aduhelm turned out to be financially underperforming, making $3 million in revenue for the entirety of 2021.

In a statement to the report, Biogen said it cooperated with the committee and “supported the integrity of the actions we took.” Biogen’s statement also cited an internal FDA investigation. It was concluded that there was no evidence of impropriety in dealings between the FDA and the company.

Biogen stuck to the original price tag of $56,000 a year, but it was predicted that the drug could ultimately cost Medicare up to $12 billion a year. Other Alzheimer’s drugs are sold at much lower prices. His annual supply cost of Aricept is less than $8,000. A drug in the same family, Exelon, costs about $8,800 for a year’s supply. Namenda costs less than $3,000 a year.

The report outlines recommendations the FDA should follow to “help restore the trust of the American public,” and steps Biogen and other pharmaceutical companies should take to “fulfill their responsibilities to patients and families.” . The recommendation is for the FDA and company to change policy, so it’s unclear if future episodes like this can actually be prevented from occurring.

The committee established a system for the FDA to document all communications with drug sponsors, to produce reports used to partner with companies and brief their own advisory committees, and to establish a system for new Alzheimer’s diseases. recommended updating formal guidance on drug development and review.

As recommended by the panel, drug sponsors should articulate their concerns about treatment safety and efficacy to FDA and consider input from outside experts when pricing new drugs. I have.

Aduhelm, a laboratory-made protein that is administered directly into a patient’s vein, is said to work by reducing a sticky substance in the brain called amyloid beta. Some scientists theorize that accumulation of amyloid beta in the brain causes Alzheimer’s disease.

In September 2015, Biogen began enrolling patients into two Phase 3 clinical trials. The trial tests the drug’s safety and effectiveness and compares it to standard care. Three and a half years later, in March 2019, the company received an independent report concluding that treatment was unlikely to delay memory loss, confusion and other symptoms of brain damage caused by Alzheimer’s disease. I have announced that I will finish both exams.

However, the drug’s death was short-lived.

The report shows that two months after the trial was stopped, representatives from Biogen and the FDA met at a neurological conference in Philadelphia to discuss the trial’s results. FDA officials have suggested that the agency and the company schedule a special meeting to discuss data from the trial.

FDA documents reviewed in a new report show that Biogen has begun informal discussions with the FDA to review data from uncompleted trials to see if they provide any benefit to patients. At a meeting between the FDA and Biogen in mid-June 2019, the companies agreed to establish a joint “working group.”

The collaboration will lead the FDA and Biogen to move the drug forward, even though staff at both the agency and the company have expressed reservations about some of the decisions made.

For example, FDA failed to obtain the endorsement of a single member of its own advisory committee, nor did it submit ideas for discussion by internal or external agencies. issued an approval.

Furthermore, the FDA’s approval runs counter to its own guidelines for early-stage Alzheimer’s disease treatment, stating “there is not enough reliable evidence” that the drug’s effect on amyloid-beta alone would provide sufficient benefit to patients. . Scientists have expressed conflicting opinions about whether amyloid beta is the cause of Alzheimer’s disease or simply a consequence of the disease.

The report also notes that a team of Biogen staff members examined the economic impact of Aduhelm’s initial price on patients, concluding that “populations of 65 and above will face hardships” in the country. also revealed. [their] ability to pay. The team estimated that her two-thirds of Medicare patients at risk of developing Alzheimer’s disease would have to pay some of the costs themselves. .

The report found that the company “appears to have developed financial assistance programs for eligible patients,” but investigators wrote that “these programs would leave significant gaps in coverage.” .

Despite the hardships the price is expected to impose on patients, Biogen expected to spend “$500 million to $600 million to build sales force” to market the drug.

Five months after the drug hit the market, the Centers for Medicare and Medicaid Services announced that Medicare Part B monthly premiums would increase by 14.5% in 2022.

The percentage increase meant a $21.60 increase in monthly premiums for Medicare Part B beneficiaries, “reported to be the largest dollar increase in the history of the program,” according to the report. .

Biogen has gone ahead with the broad label that Aduhelm is for “Alzheimer’s patients.” trial. Some people within the company expressed concern that proceeding with the labeling plan “could undermine the company’s credibility.”

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