State Joins National Settlement with Shire Pharmaceuticals

Resolving Inappropriate Marketing Allegations

Attorney General George Jepsen, Chief State’s Attorney Kevin T. Kane and state Department of Social Services (DSS) Commissioner Roderick L. Bremby announced today that Connecticut has joined a federal-state settlement with Shire Pharmaceuticals, LLC to resolve allegations that the company inappropriately marketed Adderall XR, Vyvanse, Daytrona, Lialda and Pentasa for conditions not approved by the Food and Drug Administration (FDA).

The states alleged that, between February 2007 and September 2010, Shire promoted the sale and use of these drugs by claiming Adderall XR as clinically superior to other ADHD drugs and for the treatment of Conduct Disorder; Vyvanse as preventing certain negative consequences of ADHD and, along with Daytrona as harder to abuse than Adderall XR or other ADHD medications; Lialda for the prevention of colorectal cancer and Pentasa for the treatment of indeterminate colitis and Crohn’s Disease-all of which were allegedly made without sufficient clinical data and the backing of the FDA.  Adderall XR, Vyvanse, Daytrona are all approved by the FDA for the treatment of Attention Deficit Hyperactivity Disorder and Lialda and Pentasa are approved for the treatment of mildly to moderately active ulcerative colitis.

The Pennsylvania-based company will pay the states and federal government $56.5 million, of which $48.1 will go to Medicaid programs to resolve civil allegations that caused false claims to be submitted to government health care programs. The portion of the settlement attributable to the state and federal shares of Connecticut’s Medicaid program is $388,144.98, of which $189,337.55 represents the net state share. Connecticut will receive an additional $15,152.57 for state-specific prescription drug programs administered by DSS.

“Improper marketing of drugs leads to false and fraudulent claims against our Medicaid program,” said Attorney General Jepsen. “We take all allegations of fraud and abuse very seriously, and we will continue to work to hold accountable those who seek to defraud our taxpayers. I thank the Chief State’s Attorney and the Department of Social Services for their continued partnership in these matters.”

Chief State’s Attorney Kane commended the Medicaid Fraud Control Unit in the Office of the Chief State’s Attorney, the Office of the Attorney General and the Department of Social Services for their continued efforts to recover scarce public resources and protect the integrity of the Medicaid program.

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.

Anyone with knowledge of suspected fraud or abuse in the healthcare system is asked to contact the Medicaid Fraud Control Unit in the Office of the Chief State’s Attorney at 860-258-5986 or by email at conndcj@ct.gov; the Attorney General’s Antitrust and Government Program Fraud Department at 860-808-5040 or by email at ag.fraud@ct.gov; or the DSS fraud reporting hotline at 1-800-842-2155 or by email at providerfraud.dss@ct.gov.

Please click here to view the settlement documents.

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