- Bob Roehr
- 1Washington, DC
GlaxoSmithKline has agreed to plead guilty and pay $3bn (£2bn; €2.4bn) in penalties for unlawful promotion of prescription drugs, failure to report safety data, and false price reporting.
It also signed a 123 page corporate integrity agreement with the US Department of Justice that regulates its activity for the next five years.1
The fine is the largest on record imposed on a drug company in the United States and follows closely on the heels of another huge penalty, $1.6bn, levied on Abbott Laboratories in May for its marketing of valproic acid.2
GSK’s agreement covers several of the its leading drugs. It illegally promoted the antidepressant paroxetine for treating patients under the age of 18, even though the Food and Drug Administration never approved the drug for that age group. The company also created “misleading” journal articles claiming efficacy of paroxetine in that population, when in fact “the study failed to demonstrate efficacy,” the justice department said in its statement, and it hid trials that …