In an unprecedented settlement, GlaxoSmithKline (“GSK”) has agreed to pay the U.S. government $3 billion to settle allegations that it knowingly issued prescription drug advertisements for uses not approved by the U.S. Food and Drug Administration (“FDA”)—and then proceeded to furnish doctors with expensive gifts to convince them to write the prescriptions.
GSK, which is a leading manufacturer of prescription medication, vaccines and numerous other healthcare products, boasts on its website that “every minute more than 1,100 prescriptions are written for GSK products.” However, it is likely that a considerable portion of these prescriptions may have been written for unapproved uses. For example, there is evidence that GSK advertised Paxil for pediatric use despite the FDA having not approved use of the antidepressant by those under the age of 18. Additionally, the Department of Justice (“DOJ”) has alleged that GSK impermissibly pushed the use of other drugs for the unapproved treatment of depression.
The GSK settlement is the largest healthcare fraud settlement in U.S. history. Speaking to the magnitude of the settlement, Deputy Attorney General for the DOJ, Jim Cole, said that the “multi-billion dollar settlement is unprecedented in both size and scope. It underscores the Administration’s firm commitment to protecting the American people and holding accountable those who commit health care fraud.” GSK maintains that it has “fundamentally changed . . . procedures for compliance, marketing and selling in the USA to ensure that [it] operate[s] with high standards of integrity . . . .”
Unfortunately, the GSK settlement joins a growing list of similar settlements for healthcare fraud and other marketing infractions. In fact, it is expected that in coming months a settlement will be reached between the DOJ and Johnson & Johnson for alleged misconduct involving antipsychotic drug Risperdal.