Attorney General Joseph A. Foster announces that New Hampshire 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: Adderall 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. As part of this settlement, New Hampshire will receive more than $200,000 in restitution and other recovery.

Adderall 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 abuseable than Adderall 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 despite the fact that Daytrona, a patch applied product, did not effectively adhere to the patient's body, making it therapeutically less effective;
• promoted Lialda for the prevention of colorectal cancer, an indication not approved by the FDA; and
• 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 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.

A National Association of Medicaid Fraud Control Units Team participated in the investigation and conducted settlement negotiations with Shire on behalf of the states.