A New York federal district judge cited free speech in ruling that the Food and Drug Administration (FDA) could not prevent a company from promoting a drug for unapproved uses. The court ruled that Amarin Pharma Inc. could provide doctors with studies showing the drug Vascepa reduced moderately high blood fats without FDA approval of that use so long as the claims were truthful. (Wall Street Journal, August 7, 2015, by Thomas Burton)
The FDA had already said they did not object to much of what Amarin wanted to disseminate about Vascepa. The FDA is working on guidelines on off-label uses of drugs and is concerned that truthful information can be overcome by marketing and risks associated with the use of a drug downplayed. (FiercePharma, August 7, 2015, by Eric Palmer)
An Amarin lawyer said the decision broke new ground. “This is the first decision, I think, that clearly and unequivocally rebuffs the government’s view that off-label promotion can be prosecuted, even if truthful and nonmisleading,” said Joel Kurtzberg. A 2002 federal court dismissed the conviction of a drug company sales rep who had promoted an off-label use for a narcolepsy drug. The 2-1 ruling held that the rep’s speech was protected so long as it was truthful and not misleading. (The New York Times, August 7, 2015, by Andrew Pollack)
Writing in Newsweek, August 4, 2015, legal experts John C. Coates IV and Ron Fein warn that American companies are relying too much on exerting their power in courts, legislatures and regulatory agencies. In some cases they seek profit through the First Amendment to the detriment of democracy and in the long run economic vigor.