The U.S. Food and Drug Administration failed to follow its own internal guidelines and practices during the approval process for Biogen’s Alzheimer’s drug Aduhelm, which was “plagued with irregularities”, a congress report shown Thursday.
The FDA’s interactions with Biogen were “atypical” and did not follow the agency’s documentation protocol, according to a staff report on the findings of an 18-month investigation by two House of Representatives committees into the regulatory review, approval, pricing and marketing.
The FDA approved Aduhelm in June 2021 under an accelerated approval process despite objections of its panel of external advisorswho didn’t believe the data definitively proved the drug’s benefits for patients.
It was cleared based on evidence that it could reduce brain plaquesa probable contributor to Alzheimer’s disease, rather than evidence that it slowed the progression of the deadly disease of the mind.
the Restricted Medicare coveragewhich has led to extremely limited use of the Biogen drug.
Biogen priced “unjustifiably high” by initially pricing Aduhelm at $56,000 per year despite the lack of demonstrated clinical benefit in a broad patient population, according to the report, adding that Biogen’s own internal projections society showed that they expected the drug to be a burden. to Medicare and costly for patients.
“The findings of this report raise serious concerns about the FDA’s failings in protocol and Biogen’s disregard for Aduhelm’s efficacy and access to the approval process,” the report, prepared by staff at the House Committee on Oversight and Reform and the House Committee on Energy and Commerce concluded.
The agency should ensure that all material interactions with drug sponsors are properly documented, establish a protocol for joint disclosure documents with drug sponsors, and update its industry guidance on developments and the review of new drugs for Alzheimer’s disease, the report recommended.
Biogen and other drugmakers should communicate any safety and efficacy concerns to the FDA, as well as consider value and patient access when setting prices, according to the report.
An FDA spokesperson said the FDA’s decision to approve Aduhelm was based on a scientific evaluation of the data contained in the application.
He pointed out that the FDA’s internal review concluded that its staff’s interactions with Biogen were appropriate.
“It is the agency’s job to interact frequently with companies to ensure that we have adequate information to inform our regulatory decision-making. We will continue to do so because it is in the best interests of patients,” he said, adding that the agency will continue to use the expedited approval pathway whenever appropriate.
The FDA has already begun implementing some of the report’s recommendations, the spokesperson said.
“Biogen stands behind the integrity of the actions we have taken,” the Cambridge, Mass.-based biotech company said in an emailed statement.
“As noted in the Congressional Report, a (FDA) review concluded that “there is no evidence that these pre-filing sponsor interactions were anything but appropriate in this situation,” Biogen said.
Documents obtained by the committees show that FDA and Biogen staff held at least 115 meetings, calls and email exchanges over a 12-month period beginning in July 2019.
The total number of meetings is unknown because the FDA did not keep clear records of informal meetings and interactions between its staff and Biogen representatives. The investigation identified 66 additional calls and email exchanges that were not logged.
The FDA improperly collaborated with Biogen on a joint briefing document for the Peripheral and Central Nervous System (PCNS) Advisory Committee, the report says, with FDA and Biogen staff working closely for months before November 1. February 6, 2020 meeting to prepare the document, which failed to adequately represent the differing views within the agency.
“Using a documented joint briefing allowed Biogen to gain advance insight into FDA responses and direct guidance from the agency in drafting the company’s own departments. For example, during an exchange of the draft briefing document on October 9, 2020, FDA staff asked Biogen to move a paragraph authored by the agency to the Biogen section of the memorandum – a change reflected when the document was finalized,” the report made public. to media organizations said.
When none of the advisory committee members voted to approve Aduhelm, the FDA turned to using its fast-track approval pathway — typically used for rare diseases or small patient populations that don’t have no access to effective treatments – despite having considered the drug under the traditional approval path for nine years. .month, according to the report.
He did so on a significantly abbreviated schedule, approving it after three weeks of review, and for a broad label indication of “people with Alzheimer’s disease” that was unsupported by clinical data. , according to the report.
Internal documents obtained by the investigation showed that Biogen accepted the indication despite its own reservations about the lack of evidence that Aduhelm could help patients at stages of the disease outside of its clinical trials.
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