Novo Nordisk pays $26.7 million to settle claims

June 11, 2011

Danish drug company Novo Nordisk has agreed to pay $25 million to settle allegations that it promoted the misuse of blood clotting drug NovoSeven, the US Justice Department announced Friday.

Separately, the company will also pay a $1.7 million settlement over allegations that it encouraged fraudulent claims to be submitted to a government-run for two diabetes drugs, a top Justice Department official said.

In a statement on its website, Novo Nordisk acknowledged both settlements, but said that in each case, the company had not admitted to any wrongdoing.

It also said that as part of the settlement, it has entered into a five-year "corporate integrity" agreement with the US Department of Health and Human Services.

In the NovoSeven case, Novo Nordisk allegedly promoted the drug for so-called "off-label" purposes that had not been approved by the US .

Off-label uses indicate that false claims were submitted to government health programs that were not intended to be reimbursable.

According to the Justice Department, Novo Nordisk's US subsidiary promoted NovoSeven, which has only been approved to treat certain bleeding disorders in hemophiliacs, for use as a clotting agent with , and surgeries.

Even the US Department of Defense "was influenced by Novo's unlawful off-label promotion and purchased NovoSeven to treat service members wounded in Iraq and Afghanistan," according to the Justice Department.

Assistant US Attorney General Tony West said "the off-label promotion alleged here not only wasted taxpayer dollars, but also undermined the FDA's important role in ensuring that drugs are properly marketed to government agencies and members of the public."

In the case of the two diabetes drugs, the official said Novo Nordisk sales representatives in four states and the US capital Washington paid pharmacists at the national drug chain Rite Aid to recommend both Novolin and Novolog products.

According to the allegations, the pharmacists accessed or allowed Novo Nordisk sales representatives to see confidential patient information to try to steer those patients away from using competitor .

"When pharmaceutical companies pay kickbacks, as Novo Nordisk is alleged to have done, it is especially insidious because patients may not be receiving untainted medical advice," said Tom O'Donnell, a Health and Human Services inspector in New York.

"When those in the health care industry insist on misusing private patient health information at taxpayer expense, they should not be surprised when they are held accountable for their actions," O'Donnell added in a statement.

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