DENVER (CN) - GlaxoSmithKline will pay $105 million to 44 states for giving its sales reps financial incentives to make misleading statements to doctors about Advair, Paxil and Wellbutrin.
Attorneys general for 44 states and the District of Columbia sued the drug company for deceptive trade and consumer law violations.
This is not GlaxoSmithKline's first legal rodeo. In 2012, it paid $3 billion as part of a settlement
for failing to report safety data to the FDA, reporting false prices and introducing misbranded drugs. That settlement involved Avandia, Paxil and Wellbutrin. At the time, it was the largest health-care fraud settlement in U.S. history.
The new lawsuits involve Paxil and Wellbutrin, two anti-depressants, and the asthma medication Advair.
According to Colorado's complaint, in Denver County Court, the FDA required Glaxo to include several warnings about Advair, including that the drug should not be used by patients who can manage their symptoms on a low or medium doses of medication.
But Colorado claims: "From the time of Advair's launch in 2000 until the 2010 label changes, GSK used false and misleading representations to promote Advair as a first line treatment for all asthma patients, including mild asthma patients who were not on ICS medication and only used SABAs [short-acting beta agonists] intermittently.
"GSK also provided financial incentives to GSK sales representatives to promote Advair for mild patients, which encouraged sales representatives to make false and misleading representations to health care professionals.
"GSK also promoted Advair as a first-line treatment for mild asthma patients by distributing clinical trials that had been determined by the FDA to be insufficient evidence disclosing health care professionals that the FDA rejected that evidence as insufficient."
In the case of Wellbutrin, a drug used for depression in adults, GSK tried to encourage healthcare providers to use the medicine for more than its intended use by offering by big perks and exotic trips, the attorney general says.
"GSK engaged in the off-label promotion of Wellbutrin by encouraging sales representatives to detail health care professionals directly on the off-label uses; through speaker programs that promoted off-label; through continuing medical education programs; by paying health care professionals to attend lavish meetings in places like Jamaica and Bermuda where GSK provided off-label information about Wellbutrin; and by paying health care professionals to be 'consultants' on 'advisory boards' where they were presented with information about off-label uses," the complaint states.
Doctors are allowed to prescribe drugs for off-label uses, but drug companies are not allowed to push drugs for off-label uses.
Finally, Glaxo promoted Paxil as safe and effective for children and adolescents even though the FDA never approved the medication for patients younger than 18 and the drug has been associated with increased risk of youth suicide, the attorney general says.