The controversial approval of Biogen’s Alzheimer’s drug, Aduhelm, has propelled investigations in at least two Congressional committees – the Committee on Oversight and Reform and the Committee on Energy and Commerce. Representatives Carolyn Maloney and Frank Pallone, Jr., chairpersons of the aforementioned committees, released a joint statement expressing their concerns, saying, “We have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical benefit.” Maloney and Pallone noted that their Committees would begin investigations “so Congress and the American people can better understand why this drug was approved, how Biogen set its price and what impact this will have on research for future Alzheimer’s treatments and federal health care programs.”
Background
Readers may remember the rocky road to approval: the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) within the United States Food and Drug Administration (FDA) unanimously recommended against approving Aduhelm to treat Alzheimer’s in November 2020 as there was not reasonable evidence of the drug’s effectiveness to treat Alzheimer’s. However, in June 2021, the FDA approved the drug for broad usage, “for the treatment of Alzheimer’s disease.” After the FDA approval, three PCNS members resigned in protest.
Further drawing the ire of Congress – and others – is the list price of $56,000 per year. According to the Kaiser Family Foundation, at such a price, Medicare could spend $57 billion (or more) on an annual basis on the drug – more than Medicare Part B spends on all other drugs combined.
Congressional Action
On July 12, 2021, Maloney and Pallone sent a letter to Michel Vounatsos, CEO of Biogen, asking for a slew of documents from January 2018 to present.
New Allegations
The letter also includes relatively new allegations that in the months following the clinical studies, “Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm. Contrary to FDA guidance on communication between companies and the agency during drug development, in May 2019 a company official reportedly arranged for an “off-the-books” meeting to explore potential avenues for approval with FDA’s Director of the Office of Neuroscience,” which was reportedly followed by a formal meeting between the FDA and company in June 2019.
Following that June 2019 formal meeting, the FDA and Biogen reportedly created a “working group” that consisted of Biogen executives and FDA officials which kept in “almost daily” communication through June, July, and August 2019.
Pricing Concerns
The letter also references the $56,000 annual list price, stating that according to an independent analysis, “a fair price for Aduhelm would be a small fraction of Biogen’s price – between $3,000 and $8,400 per year.” This seems to run contrary to Biogen’s claims that the price is “fair” and “substantiated by the value it is expected to bring.”
Information Sought
Included among the request are: all internal and external documents and communications relating to assessments of the safety, efficacy, or clinical benefit of aducanumab; all internal and external documents and communications relating to the regulatory reviews process and approval of aducanumab; and all internal and external documents and communications relating to Biogen’s pricing, manufacturing costs, commercialization, or potential marketing strategies for aducanumab.
Maloney and Pallone also seek information regarding the business units, components, or divisions within the company that are involved in the commercialization or pricing of the drug, as well as organizational charts within those entities and a list of all third-party entities that provided services to Biogen related to its regulatory or pricing strategies for aducanumab.