FOR IMMEDIATE RELEASE : Thursday, September 25, 2014
CONTACT: Sara Rabern (605)773-3215
Shire Pharmaceuticals Pays $56.5 Million to Resolve Off-Label Marketing Allegations
PIERRE, S.D – Attorney General Marty Jackley announced today that South Dakota 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 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.
The total portion of the settlement amount recovered by South Dakota is $161,396.99, of which $100,634.49 will be retained by the federal government as the federal Medicaid share. The remaining $60,762.50 will go to the state general fund to offset alleged Medicaid damages in this case.
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 abusable than Adderrall XR or other ADHD medications despite a lack of clinical data to support such claims;
• promoted Daytrona as less abusable 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. Shire was fully cooperative throughout the investigation, and the NAMFCU Team recognizes the Company’s willingness to work with NAMFCU to resolve this matter.
The South Dakota Medicaid Fraud Control Unit and the South Dakota Department of Social Services assisted in recovering the settlement money. For additional information about this recovery please contact Sara Rabern at 605-773-3215.
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