Novo Nordisk to pay $25 million to settle US probe

Danish pharmaceutical company Novo Nordisk has agreed to pay $25 million to the US government for illegally promoting its haemostasis management drug, NovoSeven.

The US Food and Drug Administration (FDA) had approved NovoSeven to treat certain bleeding disorders in haemophiliacs. Once approved by the FDA, a manufacturer may not market or promote a drug for any use not specified in its new drug application and approved by the FDA. Such unapproved uses are also known as ''off-label'' uses.

Novo Nordisk' US subsidiary promoted NovoSeven to health care professionals for off-label uses, including as a coagulatory agent for trauma patients, general surgery, cardiac surgery, liver surgery, liver transplants and intra-cerebral haemorrhage.

The US Department of Justice alleged that Novo Nordisk filed false claims with government health care programmes that were not reimbursable. Medicare and Medicaid paid for off-label prescriptions throughout the US as a result of Novo's focused campaign to influence doctors and hospitals.

''Pharmaceuticals should be marketed only for uses that the FDA has approved as safe and effective,'' said DoJ's Assistant Attorney General, Tony West. ''The off-label promotion alleged here not only wasted taxpayer dollars, but also undermined the FDA's role in ensuring that drugs are properly marketed to government agencies and members of the public.''

The settlement resolves a whistleblower lawsuit filed under the quitam or whistleblower provisions of the False Claims Act and as part of the deal, the whistleblowers will receive more than $3.5 million from the federal share of the civil recovery.