Jim Boyle Sep. 26, 2014, 9:19am


Pharmaceutical company Shire Pharmaceuticals LLC will pay $56.5 million to resolve allegations that it violated the False Claims Act as a result of its marketing and promotion of several drugs, the U.S. Justice Department announced this week.


Shire, located in Wayne, Pa. and headquartered in Dublin, Ireland, manufactures and sells pharmaceuticals, including 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. As part of the settlement, Shire admits no wrongdoing in the allegations.


“Patients and health care providers must receive accurate information about available prescription drugs so that they can make safe and informed treatment decisions,” said Acting Assistant Attorney General for the Justice Department’s Civil Division Joyce R. Branda in a statement.  “The Department of Justice will be vigilant to hold accountable pharmaceutical companies that provide misleading information regarding a drug’s safety or efficacy.”


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


Among the unsupported claims allegedly made by Shire was that Adderall XR was clinically superior to other ADHD drugs because it would “normalize” its recipients, rendering them indistinguishable from their non-ADHD peers.


Shire allegedly stated that its competitors’ products could not achieve similar results and marketed Adderall XR based on claims that it would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents, and sexually transmitted disease.  In addition, Shire promoted Adderall XR for the treatment of conduct disorder, an indication not approved by the Food and Drug Administration (FDA).


The agreement also settles allegations that, between February 2007 and September 2010, Shire sales representatives and other agents made false and misleading statements about the efficacy and abuse liability of Vyvanse to state Medicaid formulary committees and to individual physicians.


For example, one Shire medical science liaison allegedly told a state board that Vyvanse “provides less abuse liability” than “every other long-acting release mechanism” on the market.  No study Shire conducted concluded that Vyvanse was not abusable, and, as an amphetamine product, the Vyvanse label included an FDA-mandated black box warning for its potential for misuse and abuse.  Shire also made unsupported claims that treatment with Vyvanse would prevent car accidents, divorce, being arrested, and unemployment.


Additionally, the settlement resolves allegations that, from April 2006 to September 2010, Shire representatives improperly marketed Daytrana, administered through a patch, as less abusable than traditional, pill-based medications.  The settlement also resolves allegations that, for part of the foregoing periods, Shire representatives improperly made phone calls and drafted letters to state Medicaid authorities to assist physicians with the prior authorization process for prescriptions to induce these physicians to prescribe Daytrana and Vyvanse.


Finally, the company settled 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.  Specifically, the government alleged that Shire promoted Lialda off-label for the prevention of colorectal cancer.


As a result of today’s $56.5 million settlement, the federal government will receive approximately $35 million, and state Medicaid programs will receive more than $20 million.  The Medicaid program is funded jointly by the federal and state governments.  In addition, Shire has separately reached agreement with the U.S. Department of Health and Human Services (HHS) Office of the Inspector General on a Corporate Integrity Agreement, which will address the company’s future marketing efforts.

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