Off-label marketing by Merck of its pain-killer, Vioxx, resulted in a $950 million settlement for violation of marketing laws:
The Justice Department said the Whitehouse Station, N.J., company marketed Vioxx as a treatment for rheumatoid arthritis without federal approval for almost three years and made false settlements about the cardiovascular safety of Vioxx to increase sales. The drug was taken off the market in September 2004 after evidence showed it doubled the risk of heart attack and stroke…. Merck is not acknowledging any liability or wrongdoing, and it says the federal government agrees there is no basis to conclude Merck’s management was involved in the illegal marketing. Merck is also entering into a corporate integrity agreement with the federal government. The Food and Drug Administration first approved the painkiller in May 1999, and the Justice Department said the company began illegally promoting Vioxx as a rheumatoid arthritis treatment almost immediately. Companies are not allowed to market drugs for conditions that have not been approved by the FDA. The Justice Department says the FDA warned Merck about its marketing practices in September 2001. Vioxx was not approved for use in rheumatoid arthritis until April 2002.
Off-label drug use when recommended by a physician is not necessarily illegal. States have jurisdiction over the practice of medicine. But the FDA has jurisdiction over interstate practices involving distribution of pharmaceutical drugs. And promoting an FDA-approved drug for an unapproved use can general substantial criminal fines and penalties. For legal issue relating to off-label use of drugs and medical devices, contact an experienced FDA attorney for legal advice.