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ATTORNEY GENERAL HERRING AND 44 OTHER ATTORNEYS GENERAL REACH $105 MILLION SETTLEMENT WITH GSK CONCERNING PHARMACEUTICAL MARKETING
RICHMOND (June 4, 2014)--Attorney General Mark R. Herring announced today Virginia will receive $2.35 million as part of a $105 million settlement between 45 states and GlaxoSmithKline LLC to resolve allegations that the pharmaceutical manufacturer violated the Virginia Consumer Protection Act and other states' consumer protection laws by promoting its asthma drug, Advair, and two antidepressant drugs, Paxil and Wellbutrin, for unapproved uses. Funds from the settlement will be used to support future consumer protection enforcement activities in the Commonwealth.
"Drug companies will not endanger the health of Virginians by marketing their drugs as effective for uses that the FDA has not approved," Attorney General Herring said. "This settlement and similar recent settlements are sending that important message while helping to prevent future violations by ensuring that sales teams are not incentivized to violate the law."
As part of the settlement, GSK is required to continue through March of 2019 its Patient First Program, which reduces financial incentives for sales representatives to engage in deceptive marketing. GSK is also required to make scientifically trained personnel ultimately responsible for developing and approving unbiased, non-promotional responses to health care provider questions.
In addition, GSK must also change its marketing practices. Specifically, GSK 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 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 for Industry.
The settlement, which is in the form of a consent judgment, has been filed with the Circuit Court for the City of Richmond for approval.
The Attorney General's Consumer Protection Section helps educate Virginians about fraud and investigates and acts on consumer complaints. In 2013, the Consumer Protection Section processed 3,994 written complaints, provided information to 28,276 callers to its Consumer Hotline and recovered $695,829 for consumers through its dispute resolution efforts. The Consumer Protection Section also provides consumer education through the issuance of consumer alerts and resource materials as well as through outreach in the form of speeches, workshops and community events.
If anyone feels they may have been a victim of an illegal business practice, they can get more information on the Consumer Protection Section or file a complaint by visiting www.ag.virginia.gov or calling 1-800-552-9963.
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