(DES MOINES, Iowa) Attorney General Tom Miller and 37 other attorneys general today reached a $90 million settlement with GlaxoSmithKline LLC to resolve allegations that the company unlawfully promoted its diabetes drug, Avandia (Rosiglitazone).
The attorneys general alleged that GlaxoSmithKline (GSK) engaged in unfair and deceptive practices by misrepresenting Avandia’s cardiovascular risks and safety profile. In Iowa, the settlement was formalized through a petition filed this morning in Polk County District Court followed by a consent judgment approved by District Judge Eliza J. Ovrom.
On July 5th GSK pleaded guilty to failing to provide required clinical data in its annual report to the U.S. Food & Drug Administration (FDA) on Avandia’s cardiovascular safety. In that same case the company also admitted to illegally promoting the anti-depressant drug Paxil with false and misleading statements about the safety of the drug for use in children, and illegal off-label promotion of the anti-depressant drug Wellbutrin for weight loss, sexual function, and other uses for which it was not approved.
U.S. District Court Judge Rya W. Zobel ordered GSK to pay $1 billion in connection with the criminal case. GSK also agreed to pay an additional $2 billion in restitution to the federal health care programs together with other civil payments.
Last November, the FDA heavily restricted access to the drug by announcing that health care providers must enroll in a federal program if they wish to prescribe rosiglitazone medicines to outpatients or patients in long-term care facilities. The restrictions were in response to data that suggested an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
“Our settlement, on the heels of a very significant federal criminal fine, reinforces that we will not tolerate anyone who puts sales over the safety of patients,” said Miller. “My sincere hope is that GSK learns from this and that the pharmaceutical industry gets the message, as well.”
As part of the agreement, GSK agreed to reform how it markets and promotes diabetes drugs. Under terms of the settlement, the company 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.
The agreement also has the following terms that are effective for at least eight years:
- GSK must post summaries of all company-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 International Committee of Medical Journal Editors (ICMJE) uniform requirements for manuscripts submitted to biomedical journals.
Under the settlement GSK will pay $1,579,490 to Iowa’s consumer education and litigation fund.
The investigation was led by the attorneys general of Oregon and Illinois. In addition to Iowa, attorneys general also participating in the settlement include: Alabama, Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Hawaii, Idaho, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, and Wisconsin.