Biogen
Aduhelm, a congressional investigation and a $900 million kickback settlement
Biogen, the Massachusetts biotech best known for multiple sclerosis and Alzheimer's treatments, became a symbol of regulatory controversy with the 2021 approval of Aduhelm. A congressional investigation later documented an unusually close relationship between Biogen and FDA staff during the review, and criticised Biogen's pricing. Separately, Biogen paid $900 million in 2022 to settle whistleblower claims that it paid kickbacks to doctors. This article covers Aduhelm, Biogen's pricing and marketing, and the kickback allegations against the company.
Questions
Why is Biogen considered controversial?
Aduhelm — approved over the FDA's own advisers' objections, priced at $56,000, subjected to an 18-month congressional investigation and eventually discontinued — is the defining episode in a company already carrying a $900 million kickback settlement.
Biogen's reputation was most damaged by Aduhelm (aducanumab), an Alzheimer's drug the FDA approved in June 2021 over the objections of its outside advisers. The approval was followed by a price widely seen as unjustified, a spike in Medicare premiums, refusals by major health systems to use the drug, a restrictive Medicare coverage decision, an 18-month congressional investigation, and ultimately the drug's discontinuation in 2024.
Q2What did the congressional investigation into Aduhelm find?
FDA staff and Biogen had at least 115 informal meetings during the review, jointly prepared a briefing document for the advisory committee, and the agency's own statistical team had argued the evidence was insufficient.
Two House committees reviewed more than 500,000 FDA and Biogen documents and concluded in December 2022 that the review was rife with irregularities. They found FDA staff and Biogen had at least 115 meetings, calls and substantive email exchanges over 12 months, often without a clear record, and had jointly prepared a briefing document for the advisory committee, giving Biogen advance insight into the agency's thinking.
Q3How did Biogen price Aduhelm, and what did the investigation say about it?
Biogen launched at $56,000 a year because internal documents show it saw Aduhelm as an unprecedented financial opportunity — well above ICER's $3,000–$8,400 cost-effective range — and planned to spend more than $3.3 billion on sales and marketing.
Biogen launched Aduhelm at $56,000 a year, far above the $10,000 to $30,000 many observers had expected and well above ICER's estimate that a cost-effective price would be $3,000 to $8,400. The congressional report concluded Biogen set an unjustifiably high price because it saw the drug as an unprecedented financial opportunity, even though its benefit in the broad patient population was unknown.
Q4How did Aduhelm affect Medicare premiums?
CMS cited Aduhelm as the main driver of a 15% rise in 2022 Medicare Part B premiums, attributing roughly half the increase to planning for the drug — showing how a single high-priced approval can raise costs for all Medicare beneficiaries.
Because Aduhelm is an infusion given in a doctor's office, it is paid under Medicare Part B, which is funded partly through premiums paid by beneficiaries. When CMS set 2022 premiums, it projected a 15% rise and cited the potential inclusion of Aduhelm as the main reason; regulators attributed about half of the increase to contingency planning for the drug.
Q5What happened to Aduhelm in the end?
Medicare restricted it to clinical trial patients, major health systems refused to stock it, and Biogen discontinued the drug on January 31, 2024 — a cautionary chapter for accelerated approval based on an unconfirmed surrogate biomarker.
Medicare restricted coverage to patients enrolled in qualifying clinical trials, citing the significant unknowns and potential for harm. Several health systems, including the Cleveland Clinic and the Department of Veterans Affairs, declined to offer it. European regulators refused to approve it.
Q6What was Biogen's $900 million settlement about?
A whistleblower alleged Biogen paid speaker fees and consulting payments from 2009 to 2014 to induce prescriptions of Avonex, Tysabri and Tecfidera — then litigated the case alone for years after the government declined to intervene.
In September 2022 Biogen agreed to pay $900 million to resolve allegations that it caused false claims to Medicare and Medicaid by paying kickbacks to physicians. The case was brought by former employee Michael Bawduniak, who alleged that from January 2009 to March 2014 Biogen paid speaker honoraria, speaker training fees, consulting fees and meals to induce doctors to prescribe its multiple sclerosis drugs Avonex, Tysabri and Tecfidera.
Q7What were the competitive allegations in the Biogen kickback case?
The complaint alleged Biogen scheduled its own speaker events to coincide with rival Gilenya's launch to block doctors from attending, and targeted the roughly 1,200 physicians responsible for about 60% of MS prescriptions.
The complaint framed the payments as a strategy to defend Biogen's MS franchise. According to Pharmaceutical Technology, the whistleblower alleged Biogen tried to suppress sales of Novartis's Gilenya, the first oral MS drug, including by scheduling its own speaker events to coincide with Gilenya launch events so physicians could not attend.
Q8Has Biogen faced other kickback allegations?
Yes — a $22 million settlement over using two foundations to cover Medicare copays for Avonex and Tysabri, part of a wider government crackdown that also caught Novartis, Teva and Mallinckrodt.
In an earlier case, Biogen agreed to pay $22 million to resolve claims that it used two charitable foundations as conduits to pay the copays of Medicare patients taking Avonex and Tysabri. The government alleged Biogen worked with a vendor to move patients from its free-drug programme to the foundations, which received contemporaneous donations from Biogen.
Q9Why did Biogen cut Aduhelm's price in half?
Poor uptake forced a cut from $56,000 to $28,200 in December 2021 — one of the few voluntary branded list-price reductions in the industry, though the new price still far exceeded ICER's recommended range.
Biogen launched Aduhelm at $56,000 a year, and uptake was poor. In December 2021 it cut the annual price for an average-weight patient to $28,200, effective January 1, 2022, and at the same time announced plans to cut $500 million in annual costs, a signal of likely layoffs. Drugmakers rarely cut list prices voluntarily.
Q10What were Aduhelm's safety risks?
About 41% of patients on the high dose experienced amyloid-related imaging abnormalities, including brain swelling in 35% and microhaemorrhages in 19%, requiring repeated MRI monitoring throughout treatment.
The main safety concern was amyloid-related imaging abnormalities (ARIA), which include brain swelling and small bleeds visible on MRI. A secondary analysis of the two phase 3 trials, published in JAMA Neurology in November 2021, found that about 41% of patients on the high dose experienced ARIA, with brain swelling affecting 35%. Roughly a quarter of patients with swelling had symptoms, most commonly headache, confusion, dizziness and nausea, and microhaemorrhages affected about 19%.
Q11What is the lasting significance of the Biogen controversies?
Aduhelm prompted calls to tighten the accelerated approval pathway, improve FDA documentation of sponsor interactions, and reconsider how uncertain approvals can spike Medicare premiums — while the kickback cases sharpened scrutiny of speaker programmes.
The Aduhelm saga changed the policy conversation in three ways. It raised hard questions about the FDA's accelerated approval pathway, particularly when a drug is approved on a biomarker such as amyloid plaque reduction without proof of clinical benefit. It prompted the FDA to begin implementing some of the congressional report's recommendations, including better documentation of sponsor interactions. And it showed how launch pricing on uncertain evidence can spill into Medicare premiums for everyone.