Biogen has agreed to pay $900 million to settle federal and state claims that it paid kickbacks to physicians to encourage them to prescribe its drugs.
The Massachusetts Justice department announced on Sept. 26, 2022 that Biogen had agreed to pay approximately $900 million to resolve allegations concerning submissions of false claims to Medicare and Medicaid. The suit, filed and litigated by former Biogen employee, Michael Bawduniak, under the whistleblower provisions of the False Claims Act, alleged that the company paid kickbacks to physicians to induce them to prescribe Biogen drugs.
According to the department’s press release, the suit alleges that from Jan. 1, 2009, through March 18, 2014, Biogen held programs through which it offered and paid remuneration, such as speaker and consulting fees, to health care professionals to induce them to prescribe three of their drugs: Avonex (interferon beta-1a), Tysabri (natalizumab), and Tecfidera (dimethyl fumarate). These actions would be a violation of the federal Anti-Kickback Statute, which prohibits exchange (or offer to exchange) anything of value to induce or reward the referral of business reimbursable by federal healthcare programs (1).
“Bawduniak doggedly pursued this matter on behalf of the United States for over seven years,” said General Brian M. Boynton, principal deputy assistant attorney and head of the Department of Justice’s Civil Division, in the release. “The settlement announced today underscores the critical role that whistleblowers and their attorneys play in utilizing the False Claims Act to combat fraud affecting federal healthcare programs.”
Under the terms of the settlement, Biogen will pay approximately $844 million to the US and approximately $56 million to 15 states. The US will pay Bawduniak a share of the federal recovery. The claims resolved by the settlement are allegations only and there has been no determination of liability.
Source: United States Department of Justice, District of Massachusetts
1. American Society of Anaesthesiologists, “Anti-Kickback Statute and Physician Self-Referral Laws (Stark Laws),” www.asahq.org, accessed Sept. 28, 2022.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
Exosomes Field Advances with Milestones Achieved by EXO Biologics and ExoXpert
December 4th 2024EXO Biologics and ExoXpert, an EXO Biologics subsidiary, have received GMP certification of a European manufacturing facility for exosomes and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.