GSK was accused of marketing its Advair asthma drug for use by mild asthma sufferers and antidepressants Paxil and Wellbutrin for use by children and teenagers without approval from the Food and Drug Administration (FDA). As noted in past posts - eg here - regarding GSK's collision with the FDA, several antidepressants have been associated with increased risk of suicide in younger patients. US pharmaceutical companies are allowed to promote their products only for conditions specifically approved by the FDA. (Medical practitioners are allowed to prescribe medicines as they see fit, including so called off-label uses.)
Schuette comments that
Consumers shouldn't have to wonder whether financial incentives are negatively influencing their medical care. Patients should always come before profits. Michigan consumers shouldn't have to wonder whether financial incentives are negatively influencing their medical care. This settlement will help put an end to the pharmaceutical companies' practice of promoting their drugs for uses that haven't been approved by the FDA, and ensure patient safety comes first.Illinois peer Lisa Madigan commented "GlaxoSmithKline put its business interests ahead of what was best for vulnerable patients".
Under the settlement, GSK is banned from disseminating information describing any off-label use of a product, unless such information and materials are consistent with applicable FDA regulations and FDA guidance. GSK is also required to continue for five years its 'Patient First Programme' (that reduces the level of financial incentives by the company to sales representatives in order to reduce deceptive marketing) for five years.
The Complaint and Consent Judgment alleges that GlaxoSmithKline violated state consumer protection laws by misrepresenting the uses and qualities of the drugs.
Schuette's media release indicates that the settlement
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. GSK is also prohibited from disseminating information that describes any off-label use of a GSK product, unless such information and materials are consistent with applicable FDA regulations.
Today's settlement will add to the more than $127.3 million recovered from drug companies by Schuette and his Health Care Fraud Division (HCFD) since he took office in 2011, resulting from criminal restitution orders, civil judgments, court orders and settlements requiring the return of funds to the Medicaid Program.
The states that participated in the settlement announced today are: Alabama, Arizona, Arkansas, 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 Jersey, 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.