Biogen controversies

Settlement concerning alleged improper physician payments

The U.S. Department of Justice announced that Biogen agreed to pay $900 million to resolve allegations that it caused false claims to be submitted to Medicare and Medicaid through improper payments to physicians. The resolution followed a whistleblower case under the False Claims Act and did not constitute an admission of liability by Biogen.

Shareholder derivative suit against Biogen board

Lawsuit filed

The Booth Family Trust filed a derivative complaint on behalf of Biogen against its board in the District of Massachusetts, alleging breaches of fiduciary duties, violations of federal securities laws and other misconduct that caused damage to Biogen.

Aduhelm approval controversy

The FDA's accelerated approval of Aduhelm generated significant controversy because the decision relied on reduction of amyloid plaques as a surrogate endpoint while evidence of clinical benefit was disputed. The FDA advisory committee had voted overwhelmingly against approval, and subsequent debate involved trial results, regulatory standards, reimbursement, and post-approval evidence requirements.