44 state attorneys reach $105 million agreement with pharmaceutical maker

By: Matt McGovern Email
By: Matt McGovern Email

AUSTIN, TEXAS (Attorney General) - Texas Attorney General Greg Abbott and 43 other state attorneys general today secured a $105 million agreement with drug maker GlaxoSmithKline, LLC (GSK). The agreement resolves a multistate investigation against GSK for unlawfully promoting its asthma drug Advair and its antidepressant drugs Paxil and Wellbutrin.

Under the settlement agreement, GlaxoSmithKline must pay the State of Texas a total of $6.2 million. According to the states’ investigation, GSK violated state consumer protection law by misrepresenting the uses and qualities of Wellbutrin, Paxil, and Advair. State and federal law generally prohibits pharmaceutical manufacturers from marketing their drugs for “off-label” uses that have not been approved by the U.S. Food and Drug Administration (FDA).

Among its terms, today’s judgment prohibits GlaxoSmithKline from the following actions:

- Making false, misleading, or deceptive claims about any GSK product;
Promoting or distributing information describing any off-label use for a GSK product;

- Representing in promotional materials that a GSK product is better, more effective, safer, or has less serious side effects than has been demonstrated by substantial evidence or substantial clinical experience;

- Presenting favorable information or conclusions in promotional materials about a GSK product from a clinical study that is inadequate in design, scope, or conduct;

- Providing GSK product samples to health care professionals who would be expected to prescribe the sampled product for an “off-label” use – rather than for an FDA-approved use.

To the benefit of patients, today’s judgment also confirms a major change in the way pharmaceutical sales teams are motivated and compensated. Under the terms of today’s agreement, GlaxoSmithKline is required to continue its “Patients First” program at least through March 2019. The “Patients First” program reduces financial incentives for sales representatives to engage in deceptive marketing. Scientifically trained personnel must develop and approve unbiased and non-promotional responses to health care provider questions.

Oregon and Illinois led the Executive Committee, which included attorneys general from Texas, Arizona, Florida, Maryland, Pennsylvania, and Tennessee.

Additional states participating in the agreement 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.


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