|TRENTON – Acting Attorney General John J. Hoffman announced today that New Jersey will receive approximately $2.45 million as a result of its participation in a multi-state settlement with GlaxoSmithKline, LLC (GSK) that resolves allegations the company unlawfully promoted its asthma drug Advair, as well as its antidepressant drugs Paxil and Wellbutrin, for unapproved uses.
Under terms of the settlement, GSK has agreed to pay a total of $105 million to New Jersey, 43 other states and the District of Columbia to resolve allegations it violated consumer protection laws in the participating states by misrepresenting both the effectiveness and accepted uses of the three drugs.
In addition to the monetary terms, the multi-state settlement includes a number of required reforms designed to prevent future misleading or deceptive marketing and promotional practices by GSK. Under the agreement, the company is prohibited from:
- Making any written or oral claim that is false, misleading or deceptive about any GSK product;
- Making promotional claims, not approved by the federal Food and Drug Administration (FDA) 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;
- Disseminating information describing any off-label (non-FDA-approved) use of a GSK product, unless such information and materials are consistent with applicable FDA regulations and FDA Guidances for Industry;
- Promoting GSK products by presenting favorable information or conclusions from a clinical study that is inadequate in design, scope, or conduct.
“The marketing and promotion of pharmaceutical products for unapproved uses is unlawful and potentially harmful, as is misrepresenting the efficacy of any drug,” said Acting Attorney General Hoffman. ”This settlement is important to protecting New Jersey consumers because it calls for the use of only clear, objective, well-supported clinical information in the promotion of these GlaxoSmithKline medications.”
Under a Consent Judgment filed with the Superior Court in Mercer County along with a Complaint alleging violations under the New Jersey Consumer Fraud Act, GSK is required to continue its Patient First Program at least through 2019. The Patient First Program reduces financial incentives for sales representatives to engage in deceptive marketing of pharmaceutical products. 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 those responses to be unbiased and non-promotional.
Deputy Attorney General Cathleen O’Donnell, assigned to the Division of Law’s Consumer Fraud Prosecution Section, handled the GSK matter on behalf of the State.
Aside from New Jersey, participants in the GSK settlement include Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin and Wyoming.