GlaxoSmithKline (GSK) has reached a $105 million agreement with 44 states and the District of Columbia to settle lawsuits alleging the drug company marketed some of its drugs for unapproved uses. The settlement also requires GSK to pay a hefty penalty and submit to strong new rules designed to prevent future misrepresentations.
GSK did not admit any wrongdoing or liability under the settlement. The arrangement is similar to one GSK reached with the federal government two years ago, in which the company agreed to pay $3 billion to settle criminal and civil claims involving illegal marketing of its asthma drug Advair and antidepressants Paxil and Welbutrin.
GSK is accused of marketing Advair for mild asthma sufferers as an initial treatment, even when substantially cheaper alternative medications were a better treatment option for patients. GSK was also accused of promoting its antidepressants Paxil and Welbutrin as safe for children and teenagers despite studies that raised concerns about an increased risk of suicide in younger patients. GSK also allegedly promoted Welbutrin for weight loss, attention deficit disorder (ADD), addiction, anxiety, and bipolar disorder.
Pharmaceuticals can only be marketed for conditions they have been cleared by the Food and Drug Administration (FDA) to treat. However, doctors have the authority to prescribe the drugs for so-called off-label uses.
The latest agreement bans GSK from paying incentives to its salespeople, in an attempt to curb off-label promotion of its drugs. The company also is prohibited from paying doctors to promote its products.
The following states will receive payment from the settlement: 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.