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.
Biogen's multiple sclerosis business has also faced legal action, including a $900 million settlement over alleged kickbacks to prescribers and an earlier $22 million settlement over the use of charities to pay Medicare patients' copays. Biogen has consistently denied wrongdoing and did not admit liability in either settlement, but the combination has made it a frequent reference point in debates about drug approval standards and pharmaceutical marketing.