Vermont will collect $79,878 in restitution and other recoveries as its share of a national $56.5 million civil settlement with Shire Pharmaceuticals, LLC to resolve allegations that the company unlawfully marketed five of its drugs, Adderall XR, Vyvance, Daytrana, Lialda and Pentasa, resulting in overpayments by Vermont Medicaid and other government healthcare programs. Specifically, it is alleged that Shire:
- promoted Adderall XR, approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), 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, approved for the treatment of ADHD, as preventing certain negative consequences of ADHD and as less abuseable than Adderrall XR or other ADHD medications despite a lack of clinical data to support such claims;
- promoted Daytrana, approved for the treatment of ADHD, as less abuseable than pill-based medications despite a lack of clinical data to support such claims; and was aware that Daytrana, a patch applied product, demonstrated difficulty in sticking to the patient’s body, making it therapeutically less effective;
- promoted Lialda, approved for the treatment of ulcerative colitis, 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, approved for the treatment of ulcerative colitis, 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 lawsuits originally filed by whistleblowers in Pennsylvania and Illinois under the federal False Claims Act and various state false claims statutes.
Source: VT AG Sept 30, 2014