New Jersey Enters Settlement with Shire Specialty Pharmaceuticals Over Alleged Unlawful Marketing of Five Drugs

TRENTON, N.J., Sept. 26 -- The New Jersey Attorney General issued the following news release:

Acting Attorney General John J. Hoffman announced today that New Jersey will receive $543,299 as a result of its participation in a global settlement with Pennsylvania-based Shire Specialty Pharmaceuticals. The settlement resolves civil allegations that Shire unlawfully marketed and promoted five of its drugs for uses not approved by the federal Food and Drug Administration (FDA), and also made claims about the drugs' effectiveness not supported by clinical evidence.

Based in Wayne, Pa., Shire Specialty Pharmaceuticals is a division of U.K.-based Shire Pharmaceuticals. The company is alleged to have unlawfully marketed its drugs Adderrall XR, Vyvanse, Daytrona, Lialda and Pentasa, thereby causing false claims to be submitted to government health care programs.

Under terms of the civil settlement, Shire Specialty Pharmaceuticals will pay a total of $56.5 million to the participating states and the federal government.

Adderrall XR, Vyvanse and Daytrona are approved by the FDA for treatment of Attention Deficit Hyperactivity Disorder (ADHD). Lialda and Pentasa are approved for the treatment of mildly to moderately active ulcerative colitis. Shire Specialty Pharmaceuticals allegedly:

* Promoted Adderrall XR for the treatment of Conduct Disorder, a use not approved by the FDA. The company also allegedly promoted Adderall XR as clinically superior to other ADHD drugs, despite a lack of clinical data to support such claims.

* Promoted Vyvanse as preventing certain negative consequences of ADHD and as less susceptible to abuse than other ADHD medications, despite a lack of clinical data to support such claims.

* Promoted Daytrona, a patch-applied product, as less susceptible to abuse than pill-based medications, despite a lack of clinical evidence to support such claims. (The Daytrona patch also demonstrated difficulty in sticking to patients' bodies, making it therapeutically less effective.)

* Promoted Lialda for the prevention of colorectal cancer, a use not approved by the FDA, and also marketed Lialda as having greater efficacy than other medications despite a lack of clinical data to support such a claim.

* Promoted Pentasa for the treatment of indeterminate colitis and Crohn's Disease, uses for which it had not been approved by the FDA.

"Marketing and promoting pharmaceutical products for unapproved uses is a betrayal of consumer trust, it results in false billing to government health care programs and, most importantly, it is against the law," said Acting Attorney General Hoffman. "Working together with our state and federal partners, we will continue to hold accountable those who participate in such conduct."

"The kind of misleading promotion alleged in this case ultimately costs all of us through false claims to government health care programs," said Acting Insurance Fraud Prosecutor Ronald Chillemi. "At OIFP, we are committed to identifying misleading business practices -- practices that result in Medicaid fraud and abuse -- and to taking action to stop it." As a condition of settlement, Shire has entered into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company's future marketing and sales practices.

The global settlement announced today resulted from two federal qui tam or "whistleblower" lawsuits originally filed in the U.S. District Court for the Eastern District of Pennsylvania, and the U.S. District Court for the Northern District of Illinois. The lawsuits were filed under the federal False Claims Act, as well as various state false claims statutes.

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