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Attorney General Kilmartin Announces $105 Million Consumer Settlement between 45 States and GlaxoSmithKline

Rhode Island to Receive Approximately $1.2 Million

Attorney General Peter F. Kilmartin today announced a settlement that signals a major change in the way pharmaceutical sales teams are motivated and paid for the ultimate benefit of consumers. The Attorneys General of 45 states, including Rhode Island, have reached a $105 million settlement with GlaxoSmithKline, LLC (GSK) to resolve allegations that GSK unlawfully promoted its asthma drug, AdvairŽ, and antidepressant drugs, PaxilŽ and WellbutrinŽ. The State of Rhode Island will receive approximately $1.2 million through this settlement.

The Complaint and Consent Judgment filed today alleges that GSK violated state consumer protection laws by misrepresenting the uses and qualities of these drugs.

"This settlement sends a strong message to the pharmaceutical industry that the marketing of drugs for off label, or not FDA approved, uses will not be tolerated, and the information provided to consumers must be accurate and balanced," said Attorney General Kilmartin.

The Consent Judgment also requires GSK to reform its marketing and promotional practices. Specifically, the company shall not:

o Make, or cause to be made, any written or oral claim that is false, misleading, or deceptive about any GSK product; o Make promotional claims, not approved or permitted by the 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; o Present 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 GSK products in any promotional materials; o 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 product for an off-label use; or o Disseminate information describing any off-label use of a GSK product, unless such information and materials are consistent with applicable FDA regulations and FDA Guidances for Industry.

The Consent Judgment also requires GSK to continue its Patient First Program at least through March 2019. The Patient First Program reduces financial incentives for sales representatives to engage in deceptive marketing. In addition, the 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.

Related links

Department or agency: Department of the Attorney General

Online: http://www.riag.ri.gov/

Release date: 06-04-2014

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