Bringing an end to a 13-year deliberation on a whistleblower lawsuit, Biogen recently agreed to pay a $900 million settlement, amidst increased government alertness on pharmaceutical fraud.
In 2009, former Biogen employee Michael Bawduniak filed a lawsuit claiming that Biogen had violated the False Claims Act and the Anti-Kickback Statute by providing millions of dollars to healthcare providers (HCPs) as an incentive to prescribe three of its multiple sclerosis (MS) drugs. As per the US Department of Justice, Biogen paid remuneration in the form of training and consulting fees and speaker honoraria, to induce physicians to prescribe the company’s drugs, in violation of the Anti-Kickback Statute.
Between 2009 and 2014, the time period of Biogen’s alleged misconduct, the standard of care for MS involved the use of Biogen’s immunomodulatory drugs such as Avonex (Interferon beta-1a), Tecfidera (dimethyl fumarate), and Tysabri (natalizumab). In 2009, Tysabri was performing well, having yielded $776 million in sales after being first approved in 2004, as per Biogen’s 2009 financial filings. However, new MS drugs like Novartis’ Gilenya, were going to soon enter the market and increase competition within the MS therapeutic landscape. Gilenya was the first approved oral MS therapy, while Avonex is delivered via biweekly injections and Tysabri requires intravenous infusion.
In the lawsuit, on behalf of the government,...
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