Shire Pharmaceuticals Pays $56.5 Million to Resolve Off-Label Marketing Allegations

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Shire Pharmaceuticals Pays $56.5 Million to Resolve Off-Label Marketing Allegations

Attorney General Tim Fox announced today that Montana has joined with other states and the federal government to settle allegations that Shire Pharmaceuticals, LLC engaged in off-label marketing campaigns that improperly promoted five of its drugs: Adderrall XR, Vyvanse, Daytrona, Lialda and Pentasa. Shire Pharmaceuticals, a Pennsylvania based company, will pay the states and the federal government $56.5 million, of which $48.1 million will go to the Medicaid programs to resolve civil allegations that the company unlawfully marketed these drugs and thereby caused false claims to be submitted to the government health care programs.

Attorney General Fox said, “While Montana’s share of this settlement is fairly small, the big news here is that we’ll continue to hold pharmaceutical companies responsible when they deceive our providers and patients in the way they promote their products. As part of the settlement, the Montana Department of Public Health and Human Services will now receive $29,927.40 in restitution and other recoveries for the Medicaid program.”

Adderrall XR, Vyvanse and Daytrona are approved by the United States Food and Drug Administration (FDA) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Lialda and Pentasa are approved for the treatment of mildly to moderately active ulcerative colitis. Specifically, it is alleged that Shire:

• promoted Adderall XR as clinically superior to other ADHD drugs despite a lack of clinical data to support such claims and for the treatment of Conduct Disorder, an indication not approved by the FDA;

• promoted Vyvanse as preventing certain negative consequences of ADHD and as less abuseble than Adderrall XR or other ADHD medications despite a lack of clinical data to support such claims;

• promoted Daytrona as less abuseable than pill-based medications despite a lack of clinical data to support such claims; and that Daytrona, a patch applied product, demonstrated difficulty in sticking to the patient’s body, making it therapeutically less effective; and

• promoted Lialda for the prevention of colorectal cancer, an indication not approved by the FDA and marketed Lialda as having greater efficacy than other medications, despite a lack of clinical data sufficient to support such a claim;

• promoted Pentasa for the treatment of indeterminate colitis and Crohn’s Disease, indications for which it had not been approved by the FDA.

As a condition for the settlement, Shire has entered into a Corporate Integrity Agreement (CIA) with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.

The settlement resulted from two qui tam lawsuits originally filed by whistleblowers in the United States District Courts for the Eastern District of Pennsylvania and the Northern District of Illinois under the federal False Claims Act and various state false claims statutes.

A National Association of Medicaid Fraud Control Units (NAMFCU) Team participated in the investigation and conducted the settlement negotiations with Shire on behalf of the states and included representatives from the Offices of the Attorneys General for the states of California, Indiana, Michigan and New York.

Shire was fully cooperative throughout the investigation, and the NAMFCU Team recognizes the Company’s willingness to work with NAMFCU to resolve this matter.

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