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News : Health Nov 16, 2012 - 10:24:45 AM

Connecticut Joins $90 Million settlement with GlaxoSmithKline

By Attorney General George Jepsen's office

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HARTFORD, CT - Attorney General George Jepsen and state Department of Consumer Protection Commissioner William M. Rubenstein announced Thursday that Connecticut has joined a $90 million multistate settlement with GlaxoSmithKline LLC to resolve allegations that the pharmaceutical company unlawfully promoted its diabetes drug, Avandia.

Thirty-seven other states are participating in the settlement following claims that GlaxoSmithKline (GSK) engaged in unfair and deceptive practices by misrepresenting Avandia’s cardiovascular risks and by promoting the drug to physicians and other healthcare professionals with false and misleading representations about Avandia’s safety profile.

The settlement resolves the state’s claim against the company under the Connecticut Unfair Trade Practices Act. Connecticut’s share of the settlement is $1,668,482 of which $100,000 will be allocated to the state Department of Consumer Protection to support the Prescription Drug Monitoring Program and the agency’s Consumer Fund. Additionally, $100,000 will be allocated to the Office of the Attorney General’s Consumer Fund.

The remaining settlement dollars – approximately $1.4 million – will be allocated to the state’s General Fund.

“A misrepresentation of what a prescription drug does or does not do could have significant consequences on a patient’s health and wellbeing,” said Attorney General Jepsen. “This settlement sends a clear message that allegations of false or misleading claims about a drug’s benefits and risks will be taken very seriously.”

“Drug companies must act responsibly when promoting their products,” Commissioner Rubenstein said. “Today’s settlement confirms that that we will not tolerate putting profits before patient health.”

As part of the settlement, GSK may not:

· Make any false, misleading or deceptive claims about any diabetes drug;

· Make comparative safety claims not supported by substantial evidence or substantial clinical experience;

· Present favorable information previously thought of as valid but rendered invalid by contrary and more credible recent information;

· Promote investigational drugs; or

· Misuse statistics or otherwise misrepresent the nature, applicability or significance of clinical trials.

In addition, GSK agreed to post summaries of all company-sponsored observational studies or meta-analysis that it conducts that are designed to inform the effective, safe and/or appropriate use of its diabetes drugs. GSK will post summaries of any company-sponsored clinical trials of diabetes products within eight months of the primary completion date, and must register and post all company-sponsored clinical trials as required by federal law.

Earlier this year, Connecticut joined a $3 billion federal-state settlement with GSK to resolve healthcare fraud claims that the company engaged in various illegal schemes related to the marketing and pricing of drugs it manufactures, including Paxil, Wellbutrin and Avandia. The state’s share in that settlement was an estimated $11.1 million.

Assistant Attorney General Thomas Saadi of the Office of the Attorney General’s Consumer Protection unit assisted the Attorney General with this matter.

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