(AP/KHON2) — GlaxoSmithKline (GSK) is paying 44 states and the District of Columbia $105 million to settle allegations that the company unlawfully marketed the drugs Advair, Paxil and Wellbutrin for purposes that had not been approved by the Food and Drug Administration.
The State of Hawaii’s portion of the agreement is $1.2 Million.
Once the FDA approves a drug as safe and effective, a manufacturer cannot market or promote that drug for an unapproved use, a practice called off-label marketing.
“While we are certain this will put a stop to the off-label use of these drugs, we will be keeping a close eye on how the company proceeds forward in its business practices,” said the state Office of Consumer Protection’s Executive Director Bruce Kim in a press release. “Patients need to feel safe in the way their health is being treated. Profit cannot be the motivation for these decisions.”
The settlement also requires GSK to continue its Patient First Program through at least March 2019.
The Patient First Program reduces financial incentives for sales representatives to engage in deceptive marketing.
In November 2012, the state received a $1,295,174.53 settlement against GSK in a similar lawsuit over the marketing of their diabetes drug, Avandia.
Also in 2012, GSK settled a federal case that included two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the FDA.
GSK paid $3 billion in that settlement.