As readers of this blog know, following Amarin’s success in obtaining a preliminary injunction limiting FDA enforcement action against it for truthful, non-misleading off-label promotion of its prescription drug Vascepa, Pacira Pharmaceuticals filed a similar lawsuit regarding off-label promotion of its prescription drug Exparel.
While we await the FDA’s response to Pacira’s motion for preliminary injunction, there have been a few other developments.
First, Law360 reports (login required) that the FDA has removed a warning letter sent to Pacira about Exparel promotion from FDA.gov.
Second, two groups have requested permission to file amicus briefs: Pharmaceutical Research and Manufacturers of America (PhRMA) and the Medical Information Working Group (MIWG).
Third, the Pacira lawsuit was reassigned from Judge Edgardo Ramos to Judge Lewis A. Kaplan. (Judge Paul A. Engelmayer decided the Amarin preliminary injunction motion).
The government’s response to the motion for preliminary injunction is due Monday, October 26, 2015, so there will be more updates next week.
UPDATE: The response to the motion for preliminary injunction is now due November 16, 2015. See attached.