A House investigation has concluded that the Food and Drug Administration (FDA) “collaborated” with biotechnology company Biogen on the approval of its Alzheimer’s drug Aduhelm. Indeed, as 2022 comes to a close, American taxpayers are reminded yet again of the inappropriate and dishonest manner in which the FDA—the agency funded by taxpayers to ensure the safety and efficacy of the medications they take—collaborates with Big Pharma.
Eighteen months in the making, the just-released report titled “The High Price of Aduhelm’s Approval: An Investigation into FDA’s Atypical Review Process and Biogen’s Aggressive Launch Plans” found that the FDA’s approval process was “rife with irregularities.” The two House of Representatives committees—Oversight and Reform and Energy and Commerce—investigated the drug’s regulatory review, approval, pricing, and marketing. The report points to “collaboration” between Biogen and the FDA ahead of an advisory committee meeting that nevertheless resulted in none of the eleven panelists voting in favor of approval for Aduhelm (aducanumab).
Specifically, the FDA’s Peripheral and Central Nervous Systems Drugs Advisory Committee (PCNS Advisory Committee) overwhelmingly disagreed that the data proved the drug’s benefits to patients. The report notes the Committee members “did not agree that it was reasonable to consider the clinical benefit of the one successful trial as the primary evidence supporting approval.” Regardless, the FDA approved Aduhelm in 2021 under an accelerated pathway, prompting several committee members to resign in protest, initiating the lawmakers’ probe. Energy and Commerce Committee chair Frank Palline Jr. (D-NJ) commented:
“While we all support the search for new cures and treatments to address devastating diseases like Alzheimer’s, we must ensure that expediency does not take precedence over protocols that ensure the independence and scientific rigour of FDA.”
The top-line discoveries from the probe are of high-level engagement between the FDA and Biogen in the months preceding the approval, including at least 115 meetings and “substantive” email exchanges that surpassed the interaction typically seen between sponsor and regulator, as reported by Pharmaphorum. Meanwhile—reminiscent of the FDA’s negligence surrounding the mRNA COVID jabs and contradicting the agency’s internal recording policies—additional informal meetings, emails, and telephone calls were undocumented. Moreover, the report finds that the joint briefing document provided to the PCNS Advisory Committee failed to adequately represent differing views within the FDA on Aduhelm.
FDA inappropriately collaborated with Biogen before approving Aduhelm. "The report raises questions about the agency’s approval of other drugs…. 'I hope this inspires a full re-examination of the nature of the communications between FDA and industry.'" https://t.co/RQZDjEBicx
— Association of American Physicians & Surgeons (@AAPSonline) December 29, 2022
Besides ignoring the PCNS Advisory Committee’s recommendation to withhold approval, the option of accelerated approval of Aduhelm was “never posed to the PCNS Advisory Committee for discussion or vote.” The House Committee obtained documents and information showing that for nine months, the FDA initially considered Aduhelm under the traditional approval pathway used for most drugs. However, “after just a three-week period following negative internal feedback about Aduhelm’s lack of demonstrated clinical benefit necessary for traditional approval, the FDA abruptly changed course and granted approval under the accelerated approval pathway” on a substantially abbreviated timeline. The accelerated pathway allows the use of surrogate clinical endpoints to demonstrate effectiveness.
Equally condemned is the FDA’s decision to grant a broad label to Aduhelm despite a lack of demonstrated clinical data across different stages of Alzheimer’s in an overall patient population. Likewise, Oversight and Reform Committee chair Carolyn Maloney (D-NY) called the unjustifiably high price of the drug—$56,000 per year—an example of “corporate greed.” The document states that Biogen (which partnered with Bill Gates‘ $100 million Alzheimer’s research project in 2017) hoped for sales of roughly $18 million per year from the drug while ignoring the impact the outrageous price could have on the healthcare system in the United States.
Shortly after approval, Biogen slashed the price of Aduhelm in half. Still, sales remained “vanishingly small” and were “all but entirely curtailed” when the Centers for Medicare and Medicaid Services (CMS) limited reimbursement to patients enrolled in approved clinical trials. The decision affects not only Aduhelm, but other amyloid-targeting drugs in late-stage development. In the CMS statement announcing its decision, Dr. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality stated the agency is prepared to provide “broad access” via Medicare “if a drug in this class shows evidence of clinical benefit through the traditional FDA approval process.” Maloney added:
“The number of patients and families impacted by Alzheimer’s disease will continue to increase, and it is crucial that FDA and drug companies adhere to established procedures and conduct themselves with the transparency necessary to earn public trust.
I am hopeful these findings are a wake-up call for FDA to reform its practices and a call to action to my congressional colleagues to continue oversight of the pharmaceutical industry to ensure they don’t put profits over patients.“
Biogen reacted to the CMS decision remarking at the time that it was “unprecedented” as the agency had broken with the usual approach of funding drugs that the FDA approves. The company noted that the distinction between accelerated and traditional approval “has never been applied to FDA-approved medicines for other disease areas.”
Mirroring the disastrous scenario shrouding the FDA and Big Pharma’s mRNA COVID products, the House Committee report emphasized “serious concerns about the FDA’s lapses in protocol and Biogen’s disregard of efficacy and access in the approval process for Aduhelm.” Likewise, the report concludes that experts’ and stakeholders’ concerns about the FDA’s accelerated approval of the drug are justified. With numerous recommendations for the FDA, Biogen, and future drug sponsors, the 46-page report concludes:
“The criticism surrounding Aduhelm’s approval may have been avoided had FDA adhered to its own guidance and internal practices. FDA must take swift action to ensure that its processes for reviewing future Alzheimer’s disease treatments do not lead to the same doubt about the integrity of the FDA’s review.”
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— Vinay Prasad MD MPH (@VPrasadMDMPH) December 30, 2022