A decades-old prohibition on drug companies promoting unapproved uses of their products may be eroding, advocates warn.
Promotion of an unapproved use has been a thorny issue in the pharmaceutical world for years. Physicians routinely prescribe drugs for uses that are not on the government-cleared label, but companies are not allowed to promote such uses to doctors.
That might soon change after a small drug company scored a legal victory against the Food and Drug Administration on Friday. A federal court granted a preliminary injunction that would allow Amarin Pharma to promote an unapproved use for its fish oil drug Vascepa.
This ruling, and a similar one back in 2012, applies only to promotion for physicians and not directly to consumers.