Biogen has reached a final agreement to pay $900m to resolve a whistleblower lawsuit accusing the biotech company of paying kickbacks to healthcare professionals (HCPs) to encourage them to prescribe multiple sclerosis (MS) drugs.
The US Department of Justice explained in a statement that the settlement resolves a long-running lawsuit filed and litigated by former Biogen employee Michael Bawduniak, on behalf of the US government, under the whistleblower (qui tam) provisions of the False Claims Act.
According to Bawduniak’s complaint, from 1 January 2009 to 18 March 2014, Biogen offered and paid remuneration in the form of speaker honoraria, speaker training fees, consulting fees and meals to HCPs who spoke at or attended the company’s speaker programmes, speaker training meetings or consultant programmes.
This was done to encourage HCPs to prescribe the MS drugs Avonex (interferon-beta-1a), Tysabri (natalizumab) and Tecfidera (dimethyl fumarate), in violation of the Anti-Kickback Statute, it was alleged.
That resulted in false claims for payment being submitted to the government healthcare programmes Medicare and Medicaid, the Department of Justice outlined.
Biogen will pay $844m to the US government and another $56m to 15 states within the next 20 days. For pursuing the case, Bawduniak will receive about 29.6% of the federal proceeds, or about $250m, a sum believed to be the highest amount ever for US whistleblower awards.
Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division, said: “The relator diligently pursued this matter on behalf of the US for over seven years.
“The settlement announced today underscores the critical role that whistleblowers play in complementing the US’ use of the False Claims Act to combat fraud affecting federal healthcare programmes.”
The company ‘believes its intent and conduct was at all times lawful and appropriate, and Biogen denies all allegations raised in this case,’ Biogen said in a statement.
“We thank Mr Bawduniak for uncovering this behaviour and bringing it to light,” said US Attorney Rachael Rollins for the District of Massachusetts. “This matter is an important example of the vital role that whistleblowers and their attorneys can play in protecting our nation’s public healthcare programmes.”