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November 15, 2012

MADIGAN, 37 ATTORNEYS GENERAL REACH $90 MILLION SETTLEMENT WITH GLAXOSMITHKLINE

Settlement Addresses Claims by Madigan, Attorneys General of
Illegal Marketing of Diabetes Drug Avandia

Chicago — Attorney General Lisa Madigan today announced a $90 million settlement with pharmaceutical company GlaxoSmithKline reached with 37 of her counterparts over allegations that the company unlawfully promoted its diabetes drug, Avandia. Illinois will receive more than $5 million under the settlement.

In filing a joint complaint and settlement today, Madigan and the other attorneys general allege that GlaxoSmithKline engaged in unfair and deceptive marketing practices when it misrepresented the safety of Avandia and the effects it would have on a patientís cholesterol levels and cardiovascular health.

Madigan and the other attorneys general alleged the company promoted Avandia using false and misleading representations on the safety of the drug for diabetic patients. The attorneys general also alleged GlaxoSmithKline lacked scientific evidence to back up its claim that Avandia would lower a patientís cholesterol and falsely promoted the drugís cardiovascular benefits when Avandia may instead increase a patientís cardiovascular risks.

ďOur investigation demonstrated that GlaxoSmithKline had little regard for the facts or for the health and safety of the patients it targeted with its misleading marketing,Ē Madigan said.

As part of the settlement, GlaxoSmithKline will reform how it markets and promotes diabetes drugs. The company is prohibited from:

  • Making false, misleading or deceptive claims about diabetes drugs;
  • Making safety claims not supported by substantial evidence or substantial clinical experience;
  • Presenting favorable information of drugs that have been proven invalid;
  • Promoting drugs before they have received approval from the U.S. Food and Drug Administration; or
  • Misusing statistics or otherwise misrepresenting the nature, applicability or significance of clinical trials.

Under the settlement, for a period of at least eight years, GlaxoSmithKline must post summaries of all company-sponsored observational studies and company-sponsored clinical trials of diabetes products. GlaxoSmithKline must also follow requirements under federal law on registering and posting such clinical trials and comply with International Committee of Medical Journal Editors Uniform Requirements for Manuscripts submitted to biomedical journals.

The investigation was led by Madigan and the Oregon Attorney Generalís office. Also participating in the settlement are attorneys general in Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Hawaii, Idaho, Iowa, 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.

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