|September 25, 2014
Contact: Whitney Ray
Phone: (850) 245-0150
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TALLAHASSEE, Fla.—Attorney General Pam Bondi, 49 other attorneys general, and the federal government today reached a $56.5 million settlement with Shire Pharmaceuticals, LLC, a Pennsylvania based company, to resolve allegations that the company engaged in off-label marketing campaigns that improperly promoted five of its drugs: Adderrall XR, Vyvanse, Daytrona, Lialda and Pentasa. Adderrall XR, Vyvanse and Daytrona are United States Food and Drug Administration approved for treatment of Attention Deficit Hyperactivity Disorder, and Lialda and Pentasa are approved for treatment of mildly to moderately active ulcerative colitis. The Medicaid program will receive $48.1 million of the settlement to resolve civil allegations of false submitted claims to government health care programs. Florida’s share of the total Medicaid settlement amounts to more than $900,000. The settlement is the first national settlement in which Medicaid managed care damages have been calculated and included as part of a recovery.
The settlement alleges Shire Pharmaceuticals 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;
· Vyvanse as preventing certain negative consequences of ADHD and less abusable than Adderrall XR or other ADHD medications despite a lack of clinical data to support such claims;
· 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;
· 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; and
· Pentasa for the treatment of indeterminate colitis and Crohn’s Disease, indications for which it had not been approved by the FDA.
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.