For Immediate Release - June 04, 2014

GlaxoSmithKline to Pay Massachusetts $2.1 Million to Settle Claims of Promoting Off-Label Uses of Asthma Drug Advair

Company to Pay a Total of $105 Million in Multistate Pharmaceutical Settlement

BOSTON – As part of a settlement that seeks to eliminate incentive compensation for pharmaceutical sales representatives and better protect consumers, pharmaceutical company GlaxoSmithKline, LLC (GSK) will pay a total of $105 million to resolve allegations that it unlawfully promoted its asthma drug, Advair, and antidepressant drugs, Paxil and Wellbutrin, Attorney General Martha Coakley announced today. The settlement will bring more than $2.1 million to the Commonwealth.

The AG’s Office has joined 44 other states in the settlement with GSK resolving allegations that the company violated state consumer protection laws by deceptively marketing off-label uses of these drugs that were not approved by the Food and Drug Administration (FDA) for patients for whom the drugs were not safe and effective. 

“Off-label marketing of drugs for uses not approved by the FDA is illegal for a reason, as it misrepresents the safety or efficacy of certain products, putting patients’ health at risk,” AG Coakley said. “Our office will work to ensure that pharmaceutical companies do not create misguided financial incentives for sales representatives to unlawfully promote these products.”

As part of a consent judgment, filed today with the complaint in Suffolk Superior Court, GSK is required to continue its Patient First Program at least through March 2019. The program eliminates any incentive compensation to sales representatives based on the volume of sales, reducing the incentives for sales representatives to engage in deceptive marketing.

In addition, the consent judgment requires GSK to reform how it markets and promotes Advair, Paxil, Wellbutrin, and GSK’s other antidepressant drugs. GSK is prohibited from, among other things:

  • Making any written or oral claim that is false, misleading, or deceptive about these products;
  • Making promotional claims, not approved or permitted by the FDA that any of these products is better, more effective, safer, or has less serious side effects or contraindications than has been demonstrated by substantial evidence or substantial clinical experience;
  • Presenting favorable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support for such information or conclusions, when presenting information about a clinical study regarding these products in any promotional materials;
  • Providing samples of these products to those health care professionals who are not expected to prescribe the sampled products for an approved use, but who would be expected to prescribe the sampled product for an off-label use; or
  • Disseminating information describing any off-label use of these products, unless such information and materials are consistent with applicable FDA regulations and FDA Guidances for Industry. 

In November 2012, AG Coakley joined 37 states in a $90 million settlement with GSK, resolving allegations that the pharmaceutical company unlawfully promoted its diabetes drug, Avandia. That settlement was in addition to a settlement announced in July 2012 when AG Coakley obtained more than $35 million from GSK, on behalf of the Massachusetts Medicaid Program, due to its unlawful marketing of a number of drugs, including Advair, Paxil, and Wellbutrin.

Oregon and Illinois led the Executive Committee for today’s case, which also includes Attorneys General from Arizona, Florida, Maryland, Pennsylvania, Tennessee, and Texas. Also participating in the settlement 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.

Assistant Attorney General Eric Gold of Attorney General Martha Coakley’s Health Care Division handled the settlement for the Commonwealth. 

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