Shire whistleblower awarded $5.9 million in FCA settlement

Shire Pharmaceuticals LLC will pay $56 million to settle allegations that its marketing and promotion of several drugs violated the False Claims Act, the Justice Department said last week.

The allegations were contained in two lawsuits filed under the False Claims Act’s whistleblower provisions by a former Shire executive and former Shire sales representatives.

The former executive, Gerardo Torres, will receive $5.9 million.

Pennsylvania-based Shire manufactures and sells Adderall XR, Vyvanse and Daytrana, which are approved for the treatment of attention deficit hyperactivity disorder (ADHD), and Pentasa and Lialda, which are approved for the treatment of mild to moderate active ulcerative colitis.

The settlement resolves allegations that between January 2004 and December 2007, Shire promoted Adderall for certain uses despite a lack of clinical data to support such claims and overstated the efficacy of the drug.

One of the allegedly unsupported claims was that Adderall was better than other ADHD drugs because it would “normalize” its recipients, making them indistinguishable from their non-ADHD peers.

Shire also allegedly marketed Adderall based on unsupported claims that it would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents and sexually transmitted disease.

The settlement also resolves claims that between February 2007 and September 2010, Shire sales representatives made false and misleading statements about the efficacy and “abuseability” of Vyvanse to state Medicaid formulary committees and physicians. The government said no study conducted by Shire concluded that Vyvanse was not abuseable. As an amphetamine product, the Vyvanse label included an FDA-mandated black box warning for its potential for misuse and abuse.

The settlement also covers allegations that between January 2006  and June 2010 Shire sales representatives promoted Lialda and Pentasa for off-label uses not approved by the FDA and not covered by federal healthcare programs. The federal government will received $35.7 million of the $56 million settlement, and state Medicaid programs will receive $20.7 million.

“Marketing efforts that influence a doctor’s independent judgment can undermine the doctor-patient relationship and short-change the patient,” said U.S. Attorney Zane David Memeger for the Eastern District of Pennsylvania.

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A version of this post first appeared in Whistleblower Today and is published here with permission.