GSK settlement calls for promotional practices reform

The Florida attorney general's office will continue to enforce Florida's consumer protection laws to ensure that consumers receive the clear and truthful information they need

Consumers deserve fair and accurate information about the uses, effects, and other important aspects of the pharmaceutical drugs they purchase. My office helps protect consumers by pursuing material inaccuracies and misrepresentations in the marketing of pharmaceuticals as potential violations of our state consumer protection law.

Most recently, my office and other attorneys general around the country reached a $105 million settlement resulting in a consent judgment against GlaxoSmithKline (GSK). This resolved allegations that GSK unlawfully promoted its asthma drug, Advair, and antidepressant drugs Paxil and Wellbutrin. Florida was a part of the executive committee that led the multistate investigation, along with Arizona, Illinois, Maryland, Oregon, Pennsylvania, Tennessee, and Texas. The complaint filed simultaneously with the settlement alleged that GSK violated state consumer protection laws by misrepresenting the uses and qualities of these drugs. The consent judgment requires GSK to institute significant reforms in its marketing and promotional practices.

Specifically, under the consent judgment, which still must be approved by the court, GSK is prohibited from: making claims that are false, misleading, or deceptive regarding any GSK product; making promotional claims, not approved or permitted by the Food and Drug Administration, declaring a GSK product better, more effective, safer, or having less serious side effects or contraindications than has been demonstrated by substantial evidence or clinical experience; and providing samples of GSK products to those health care professionals who are not expected to prescribe the sampled GSK products for an approved use, but who would be expected to prescribe the sampled product for an off-label use.

The consent judgment also requires GSK to continue its Patient First Program, which reduces financial incentives for sales representatives to engage in deceptive marketing, through March 2019. In addition, the consent judgment requires scientifically trained personnel to be ultimately responsible for developing and approving responses to health care provider questions and for these responses to be unbiased and non-promotional.

Also participating in the consent judgment are: Alabama, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Kentucky, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Rhode Island, South Dakota, Utah, Vermont, Virginia, Washington, Wisconsin and Wyoming.

My office will continue to enforce Florida's consumer protection laws to ensure that consumers receive the clear and truthful information they need to make well informed purchase decisions.

Pam Bondi

Pam Bondi is the attorney general for the state of Florida.

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