- Amarin has initiated a lawsuit against the FDA in response to not being able to update its label with additional effectiveness information about Vascepa (prescription fish oil). And now, the FDA has responded with a letter seemingly trying to diffuse tensions over that suit, Ed Silverman reports.
- Vascepa is approved for treatment of very high triglyceride levels.
- Amarin is basing its lawsuit on its constitutional right to distribute information.
When Amarin initiated the lawsuit against the FDA for not allowing it to practice free speech under the First Amendment, it was a nod to the Caronia case in 2012 in which a sales rep won a suit allowing him to invoke First Amendment rights to detail off-label information. However, in a move that many say is an effort to blunt the impact of the suit, the FDA has written back saying that the content Amarin wants to distribute is not a problem and that Amarin never contacted the FDA to discuss.
The FDA contends that Amarin is frustrated and moved to the judicial system too quickly before attempting a constructive dialog; however, some think that by avoiding a court case, the FDA is skirting the issue of addressing free speech in the context of commercial communications in the pharma industry.
Fortunately, this is an issue that is actively being addressed by the 21st Century Cures Act. Look forward to feature coverage on the issue from BioPharma Dive later this week.