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Pharmaceutical Co. To Pay Iowa $1.5 Million
DES MOINES, IA -- Global pharmaceutical giant GlaxoSmithKline LLC (GSK) will pay the state $1.5 million and change how it compensates its sales staff and promotes its drugs, as part of a $105 million dollar settlement reached today with Attorney General Tom Miller and 43 other state attorneys general, plus the District of Columbia.
"This settlement resolves our allegations that the company violated Iowa's consumer protection laws so it could make a bigger profit," Miller said. "The company must significantly change how it markets its drugs and compensates its pharmaceutical sales teams, which will ultimately benefit consumers," Miller said.
In a petition filed in Polk County District Court, Miller alleged that GSK unlawfully promoted its asthma drug, Advair, and antidepressant drugs, Paxil and Wellbutrin by misrepresenting their uses and qualities.
A court order resolving the lawsuit, called a consent judgment, requires GSK to reform its marketing and promotional practices. Specifically, the company shall not:
Make, or cause to be made, any written or oral claim that is false, misleading, or deceptive about any GSK product;
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;
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;
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
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," which represent the agency's current thinking on particular subjects.
The consent judgment also requires GSK to continue its "Patient First Program" at least through March 2019. The program reduces financial incentives for sales representatives to engage in deceptive marketing. In addition, the court order requires scientifically trained personnel to be ultimately responsible for developing and approving responses to health care provider questions and for the responses to be unbiased and non-promotional.
GSK's payment to Iowa will go to the state's consumer education and litigation fund.
In July 2012 GlaxoSmithKline LLC pleaded guilty to federal criminal charges and agreed to a pay $3 billion to settle criminal and civil cases. It was the largest health care settlement paid by a drug company.
GSK admitted to promoting Paxil and Wellbutrin for unapproved uses and failing to report safety data about Avandia. GSK paid $1 billion to settle the criminal charges. The remaining $2 billion was part of the civil settlement over unapproved promotion and paying kickbacks, making false statements concerning the safety of Avandia, and reporting false prices to Medicaid. As part of that settlement, GSK agreed to make major changes to the way it did business.
GlaxoSmithKline LLC, based in Philadelphia, is a subsidiary of the global pharmaceutical company GlaxoSmithKline PLC, based in Britain.