Shire Pharmaceuticals LLC agrees to pay $56.5 million to resolve false claims act allegations regarding drug promotion practices

Shire Pharmaceuticals, LLC, a pharmaceuticals company based in Pennsylvania, recently signed a settlement agreement with the Department of Justice to resolve False Claims Act allegations related to its promotion practices of several drugs.  Shire, which both manufactures and sells pharmaceuticals used in treating attention deficit hyperactivity disorder (ADHD), was facing allegations that it violated the False Claims Act beginning in 2004.  The allegation part of a series of lawsuits brought by a former Shire executive and three former Shire sales representatives.  As part of the settlement, one of the whistleblowers will receive $5.9 million.

Under the settlement agreement, Shire will pay $56.5 million of which the federal government will receive $35,713,965 and state Medicaid programs will receive $20,786,034.  Shire also executed a separate agreement with HHS – termed a “corporate integrity agreement” – designed to address the company’s future marketing efforts.

The lawsuits alleged misconduct related to Shire’s marketing and promotion practices, including that, from 2004 to 2007, Shire marketed Adderall XR, an ADHD medication, on unsupported claims that it would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents, and sexually transmitted diseases.  Shire also claimed that Adderall XR could be used in the treatment of conduct disorder even though it was not approved by the FDA for such treatment.

Shire had also claimed that another of its ADHD medications, Vyvanse, was less susceptible to drug abuse than similar non-Shire products.  In fact, one Shire medical science liaison allegedly told a state formulary board that Vyvanse provides less abuse liability than “every other long-acting release mechanism” on the market.  However is was the government’s contention that no Shire study had actually concluded that Vyvanse was not abusable; to the contrary, the Vyvanse label included in FDA-mandated warning of its potential for misuse and abuse.  Shire also claimed without support that Vyvanse would prevent car accidents, divorce, arrest, and unemployment.

The full text of the DOJ press release can be found here.