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NEW: Mass to Receive $2.1 Million in Diabetes Drug Settlement

Thursday, November 15, 2012

 

Attorney General Martha Coakley’s Office has joined 37 other states in a $90 million settlement with GlaxoSmithKline LLC, resolving allegations that the pharmaceutical company unlawfully promoted its diabetes drug, Avandia, by misrepresenting its cardiovascular risks and safety profile. The settlement will bring more than $2.1 million to the Commonwealth.

“When pharmaceutical companies misrepresent the safety of their drugs, they put patients at risk,” AG Coakley said. “This settlement helps ensure that consumers will be protected from misleading marketing that can result in the unsafe use of prescription drugs.”

In order to increase their sales of Avandia in Massachusetts, the AG’s Office alleges that GlaxoSmithKline (GSK) promoted the diabetes drug to physicians and other health care providers with false and misleading representations about its safety and misrepresented the drug’s cardiovascular benefits when, in fact, the drug may instead increase risks.

Under the terms of the consent judgment, filed today in Suffolk Superior Court, GSK will pay more than $2.1 million to the Commonwealth including $100,000 for fees and investigative costs. The remaining funds will pay for programs that lower health care costs for Massachusetts residents, combat unlawful marketing practices in the health care market, or benefit health care consumers.

As part of the settlement, GSK agreed to reform how it markets and promotes diabetes drugs, and is prohibited from:

  • Making any false, misleading, or deceptive claims about any diabetes drug;
  • Making comparative safety claims not supported by substantial evidence or substantial clinical experience;
  • Presenting favorable information previously thought of as valid but rendered invalid by contrary and more credible recent information;
  • Promoting investigational drugs; or
  • Misusing statistics or otherwise misrepresenting the nature, applicability, or significance of clinical trials.
  • The consent judgment also imposes, for at least eight years, a number of requirements regarding GSK’s publication of the results of its studies, including that it register and post all GSK-sponsored clinical trials as required by federal law.

This consent judgment is in addition to a settlement announced in July when AG Coakley obtained more than $35 million from GlaxoSmithKline, on behalf of the Massachusetts Medicaid Program, due to its unlawful marketing of a number of drugs, including Avandia.

 

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