Product News and Recalls

Amarin Wins Right to Promote Drug for Off-Label Use

In a post from late June of this year, we brought you the story of Amarin Pharmaceuticals – the company arguing for the ability to promote a drug for off-label use. Their case was based on a premise that, at the time, seemed, or so we thought, far-fetched: the FDA, in carrying out its regulatory duties and keeping the public safe from harm, was violating the company’s First Amendment right to free speech.

The company sued for the right to present information directly to doctors that shows that their drugs are effective for purposes beyond those that they had originally been approved to treat. A drug may not meet FDA guidelines to be approved for certain uses but Amarin’s lawsuit suggested being prohibited from actively marketing that drug for those uses represents a violation of the company’s right to free speech.

As it turns out, a federal judge may see some validity in the pharmaceutical manufacturer’s arguments. Preliminary relief was granted to Amarin in its off-label marketing of Vascepa, a drug derived from fish oil. While the suit has not yet been completely finalized or decided, preliminary relief grants the corporation the right to begin marketing their drug for off-label uses immediately.

The ruling already has legal scholars talking. In an interview with The Washington Post, Jacob Sherkow, an associate professor at New York Law School, stated, “There have been other instances a court has held that off-label marketing is protected by the First Amendment, but…this is the first time, I think, that any federal court – that any court – has held in such a clear, full-throated way that off-label marketing is protected by the First Amendment, period, full stop.”

The scope of Amarin’s suit is, for obvious reasons, quite limited. The suit applies only to Vascepa and only to the company’s ability to promote it as a treatment for a specific condition. However, this case may put a powerful precedent in place for other companies to now use to chip away at the restrictions surrounding their own drugs.

It will take some time for the repercussions of this first move to become completely known. Until then, however, the FDA must regroup and determine a response to the fact that its power can now be circumvented as companies and corporations may begin to use the Constitution and the Bill of Rights to further their own end goals; regardless of the impact to public safety.