Another day and another drugmaker, this time Novo Nordisk, is coughing up to settle investigations into marketing practices in the USA.
The Danish drugmaker's US division has reached an agreement with the Department of Justice and two individuals to settle an investigation and civil lawsuit related to alleged improper marketing practices regarding its anti-bleeding drug NovoSeven (recombinant Factor VIIa). The complaint alleged that the company improperly promoted the treatment for unapproved indications.
Novo denies any wrongdoing but will pay $25 million to settle the case and has signed a five-year corporate integrity agreement with the US Department of Health and Human Services (HHS). The firm added that it "does not recommend or promote the off-label use of its medicines, and in fact works proactively with the US Food and Drug Administration and other government agencies to address safety concerns when physicians exercise their professional judgment to use NovoSeven outside of its approved indications".
Jim Shehan, Novo's general counsel, said Novo been cooperating with the government since the investigation began. With the settlements, "we avoid the distraction and costs of a lengthy legal battle, which would not have been in the best interest of the company or its stakeholders”.
He noted that the company has conducted FDA-approved trials with NovoSeven to investigate other uses for the product, including treatment of bleeding in patients with severe trauma. Mr Shehan argued that “our efforts have advanced the scientific understanding of uncontrolled bleeding and provided valuable data to help improve medical care in both civilian hospitals and military settings".
Alleged fraud with diabetes drugs
Novo has also agreed to pay just over $1.7 million to the US government and several states to resolve allegations it caused fraudulent claims to be submitted to the Medicaid programme in connection with the marketing of the insulin products Novolin and Novolog.
It is alleged that Novo sales reps in four states and the District of Columbia made payments to Rite Aid pharmacists in exchange for them recommending Novolin and Novolog. It is claimed that the reps were given access to confidential patient information.
The probe began after a former Novo rep filed a complaint against the company and that individual may receive a share of the cash. Again, Novo did not admit any wrongdoing.
Janice Fedarcyk of the Federal Bureau of Investigation said that "those in the healthcare industry are entrusted with the responsibility of protecting confidential patient health information". The exploitation of that "for increased profits turns taxpayers and customers into unwitting victims.”