(Thursday, November 15, 2012) -- Attorney General Tom Horne and 37 other Attorneys General have entered into a Consent Judgment with GlaxoSmithKline LLC to resolve allegations that GlaxoSmithKline [“GSK”] unlawfully promoted the diabetes drug AVANDIA®.
“Protecting consumers is a priority of my administration, and this court action is a stark reminder that consumers deserve full accountability from any entity that engages in potentially deceptive practices,” Horne said. “This Consent Judgment is tough, fair and it holds GlaxoSmithKline accountable for how the company marketed AVANDIA.”
In the accompanying lawsuit filed today, the Attorney General alleges that GSK engaged in unlawful and deceptive practices through the following methods:
- Misrepresenting and understating AVANDIA’S cardiovascular risks. The complaint alleges that GSK represented that Avandia had cardiovascular benefits when in fact AVANDIA did not provide cardiovascular benefits. In fact, AVANDIA may well have increased cardiovascular risks in patients.
- Misrepresenting that AVANDIA had a positive cholesterol profile when in fact; GSK did not have any competent and reliable scientific evidence to support its cholesterol claim.
As part of the Consent Judgment, GSK has agreed to change how it markets and promotes any diabetes drugs. Under the Consent Judgment, GSK may not:
- Claim that it diabetes drugs are safer than other manufacturers’ drugs unless GSK can support its safety claims with substantial evidence or substantial clinical experience;
- Present favorable information about its diabetes drugs using information that the scientific community once thought was valid but which became invalid because of newer contradictory and more credible information;
- Promote investigational drugs; or
- Misuse statistics;
- Misrepresent the nature, applicability, or significance of clinical trials.
The Judgment also contains, among other terms, the following:
- GSK must post summaries of all GSK-sponsored observational studies or meta-analyses that GSK conducts that are designed to inform the medical community and the public that the diabetes drugs are effective, safe, and/or appropriate for use in diabetic patients;
- GSK must post accurate summaries of GSK-sponsored clinical trials of any diabetes products within 8 months of the primary completion date.
Under the settlement Arizona will receive $3,043,663.56. The Attorney General will deposit $650,000 into the Consumer Fraud Revolving Fund for attorney’s fees and future investigations. The remaining funds are restitutionary in nature, and the Attorney General will solicit Requests for Proposal to Arizona third-party organizations and individuals for the implementation of programs to specifically address childhood obesity which can lead, later in life, to Type II Diabetes.
Joining Arizona on the Executive Committee that negotiated the settlement are the Attorneys General of Florida, Illinois, Maryland, Pennsylvania, Oregon, Tennessee, and Texas. Also participating in the settlement are Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Hawaii, Idaho, Iowa, Kansas, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Rhode Island, South Dakota, Vermont, Washington, and Wisconsin.