From the New York Times today:
“In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration. The judges said that the ban on so-called off-label marketing violated the representative’s freedom of speech.
The 2-to-1 decision by a three-judge panel of the Court of Appeals for the Second Circuit in Manhattan addresses a long-running and costly issue for the industry, which has paid billions of dollars in penalties to the federal government in recent years after being accused of marketing blockbuster drugs for off-label uses.”
(Read the entire piece here)
Recently researchers at Mayo Clinic published an article in Mayo Clinic Proceedings about the common practice of Off-Label Drug use — something that occurs even though patients may not know about it.
Off-label drug use occurs when a physician prescribes medication to treat a condition before that use has been approved by the Food and Drug Administration.
“Since the Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common,” says the studies lead author Christopher Wittich, M.D., internal medicine physician at Mayo Clinic. “Health care providers and patients should educate themselves about off-label drugs to weigh the risks and benefits before a physician prescribes one or a patient takes one.”
The physicians go on to pose several questions and answers about off-label drug use. Find an abbreviated summary here. And read the entire article here.
For reporters: To interview Dr. Wittich about off-label drug use, contact Nick Hanson at 507-284-5005 or newsbureau@mayo.edu.
