DOJ: News Release

Bullock Joins 37 Attorneys General in $90 Million Settlement with Pharmaceutical Co.

Bullock Joins 37 Attorneys General in $90 Million Settlement with Pharmaceutical Co.

Attorney General Steve Bullock today announced that he and 37 other attorneys general have reached a $90 million Consent Judgment with GlaxoSmithKline LLC to resolve allegations that the drug company unlawfully promoted its diabetes drug, Avandia.

The attorneys general allege that GlaxoSmithKline engaged in unfair and deceptive practices by misrepresenting Avandia’s cardiovascular risks and safety profile.

“Montana doctors and consumers need to be able to trust the medical information they rely on to make important health care decisions,” Bullock said. “It’s critical that companies like GSK tell the truth – the whole truth – about the drugs they make, and don’t make misleading claims using disproven studies or manipulated statistics.”

Montana’s share of the settlement is $1.2 million. Under the terms of the settlement, the money may be used to cover the cost of the investigation and litigation, to help fund Montana’s consumer protection efforts, or to fund programs related to health care issues affecting Montana consumers, including programs to prevent and treat diabetes.

As part of the Consent Judgment entered by the First Judicial District in Helena, GlaxoSmithKline agreed to reform how it markets and promotes diabetes drugs. Under the Consent Judgment, 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;
• Misuse statistics or otherwise misrepresent the nature, applicability or significance of clinical trials.

The Consent Judgment also has the following terms that are effective for at least eight years:

• GSK must post summaries of all GSK-sponsored observational studies or meta-analyses conducted by GSK that are designed to inform the effective, safe and/or appropriate use of its diabetes drugs;
• GSK shall post summaries of GSK-sponsored clinical trials of diabetes products within eight months of the primary completion date;
• GSK shall register and post all GSK-sponsored clinical trials as required by federal law; and
• GSK shall comply with the ICMJE Uniform Requirements for Manuscripts submitted to Biomedical Journals.

The investigation was led by the Attorneys General of Oregon and Illinois with an Executive Committee consisting of the Attorneys General of Arizona, Florida, Maryland, Pennsylvania, 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, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Rhode Island, South Dakota, Vermont, Washington, and Wisconsin.

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