Tag Archives: Off-label Use

An interesting legal result regarding off-label use; one to watch

Article from Reuters

A U.S. judge on Friday barred the U.S. Food and Drug Administration from stopping Irish drugmaker Amarin Corp from promoting its fish oil drug for off-label uses, saying the company is protected by the First Amendment.
The pharmaceutical industry has been watching this case because it is one of the first to raise a First Amendment argument in defense of promoting drugs for uses the FDA has not approved. Shares of Amarin rose 12 percent on Nasdaq.
The order by U.S. District Judge Paul Engelmayer in Manhattan means Amarin can promote its Vascepa pill to doctors for off-label use as long as it does so truthfully.

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