Forty-four states and the District of Columbia reached a $105 million settlement Wednesday with GlaxoSmithKlein LLC for the alleged improper marketing and promotion of the asthma drug Advair and the anti-depressant drugs Paxil and Wellbutrin.
“When pharmaceutical companies advertise drugs to consumers, their claims should be backed by the best available science, not just slick marketing,” said New York Attorney General Eric T. Schneiderman.
In a lawsuit filed in New York County Supreme Court, attorneys general from the states alleged that GSK engaged in deceptive and misleading practices when it marketed the prescription drugs Advair, Paxil, and Wellbutrin for off-label uses and hid risks associated with Paxil.
As a result of the states’ investigation, GSK agreed to change its marketing of Advair, Paxil, and Wellbutrin and to stop promoting off-label uses of the drugs, which aren’t approved by the U.S. Food and Drug Administration.
The lawsuit charged that GKS:
- Promoted Advair for treatment of mild and intermittent asthma even though it was approved by the FDA only for treatment of more serious asthma conditions.
- Promoted Wellbutrin for treatment of weight loss and sexual dysfunction through its “happy, horny, skinny pill” campaign, even though these were unapproved uses.
- Concealed and misrepresented clinical studies that demonstrated Paxil’s ineffectiveness in treating children and adolescents with major depressive disorder, as compared to a placebo group, and that demonstrated a connection between Paxil’s use and an increased risk of suicidal thoughts and acts in adolescents.
The settlement prohibits GSK from making any written or oral claim that is false, misleading, or deceptive about any GSK product.
The settlement also requires GSK to continue its Patient First Program through March 2019. The program reduces financial incentives for sales representatives to engage in deceptive marketing by removing individual sales targets and begins the process of ending direct payments to health care professionals for speaking engagements and attendance at medical conferences.
Settlement documents are available here and here.
