For Immediate Release - September 24, 2014

Pharmaceutical Company Pays $56.5 Million to Resolve Off-Label Marketing Allegations with Five of its Drugs

MassHealth to Receive $870,000 as Part of Federal-State Settlement with Shire Pharmaceuticals

BOSTON – A pharmaceutical manufacturer has agreed to pay more than $56.5 million over allegations of illegal, off-label marketing campaigns resulting in the promotion of five of its drugs for uses not approved by the U.S. Food and Drug Administration (FDA), Attorney General Martha Coakley announced today. The multi-state and federal settlement with Shire Pharmaceuticals, LLC is expected to return more than $870,000 to Massachusetts’ Medicaid program (MassHealth). 

“Off-label marketing by pharmaceutical manufacturers imposes unnecessary costs on MassHealth for products that have not been established by the FDA as safe and effective for consumers,” AG Coakley said. “We are committed to working with federal and state law enforcement nationwide to make sure these companies adhere to industry standards.”

AG Coakley joined with other states and the federal government in a global settlement with Shire Pharmaceuticals, a Pennsylvania based company, to resolve civil allegations that it unlawfully marketed the drugs Adderall XR, Vyvanse, Daytrana, Lialda and Pentasa. Adderall XR, Vyvanse and Daytrana are approved by the 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, the state and federal governments alleged that Shire promoted the drugs for a number of uses not approved by the FDA including:

  • Promoting 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;
  • Promoting Vyvanse as preventing certain negative consequences of ADHD and as less likely to be abused than Adderall XR or other ADHD medications despite a lack of clinical data to support such claims;
  • Promoting Daytrana as less likely to be abused than pill-based medications despite a lack of clinical data to support such claims; and that Daytrana, a patch applied product, demonstrated difficulty in sticking to the patient’s body, making it therapeutically less effective;
  • Promoting Lialda for the prevention of colorectal cancer, and marketed Lialda as having greater efficacy than other medications, despite a lack of clinical data sufficient to support such a claim; and
  • Promoted Pentasa for the treatment of indeterminate colitis and Crohn’s Disease.

Under the terms of the settlement, Shire will pay a total of $56.5 million to the state and federal governments, of which $48.1 million will go to the Medicaid programs in participating states, including Massachusetts.

The settlement resulted from two qui tam, or whistleblower lawsuits, originally filed 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.

As a condition of the settlement, Shire has entered into a Corporate Integrity Agreement 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.

Responsible for the investigation and prosecution of fraud against MassHealth, the Medicaid Fraud Division has recovered more than $385 million for the state’s Medicaid program during AG Coakley’s seven years in office. That total is more than five times the amount recovered during a 10-year period from 1996 to 2006, approximately $67.9 million.

The joint state-federal investigation of this matter was conducted by a team appointed by the National Association of Medicaid Fraud Control Units, the United States Department of Justice and the United States Attorney’s Office for Eastern District of Pennsylvania. Assistant Attorney General George Zachos of the AG’s Medicaid Fraud Division handled this matter on behalf of the AG’s Office with assistance from data analyst Anthony Megathlin.

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