Vermont will collect $1.4 million as its share of a settlement reached between GlaxoSmithKline, LLC, Attorney General William Sorrell and the attorneys general of 43 other States and the District of Columbia. The settlement, totaling $105 million, resolves allegations that GSK unlawfully promoted its asthma drug Advair, and antidepressant drugs Paxil and Wellbutrin, by misrepresenting the proper uses and qualities of these drugs.
“A drug manufacturer cannot be allowed to lie about which patients can safely use its drugs, nor to incentivize and reward sales teams for spreading misinformation about its drugs,” said Attorney General Sorrell. “The settlement addresses this misconduct.”
GSK must reform its marketing and promotional practices under the settlement in a number of ways. For example, GSK cannot:
- Make promotional claims that a GSK product is better, more effective, safer, or has less serious side effects or contraindications than has been demonstrated by substantial evidence or substantial clinical experience, unless those claims are allowed by the FDA;
- Provide 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 products for an off-label use; or
- Disseminate information describing any off-label use of a GSK product, unless such information and materials are consistent with applicable FDA regulations and FDA Guidance for Industry.
The settlement also requires GSK to continue its Patient First Program through at least March 2019. That program reduces financial incentives for sales representatives to engage in deceptive marketing. In addition, the settlement 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.
Vermont Attorney General 6.4.2014