The Pacira Pharmaceutical Inc. v. FDA lawsuit has been a frequent topic of discussion on the blog, and now, in breaking news, the case has been settled. Pacira will be receiving essentially everything it wanted in a “favorable resolution,” and the FDA is formally withdrawing its warning letter that attempted a retroactive reduction in the … Continue Reading
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Updates Regarding the Pacira Pharmaceutical Inc. v. FDA Lawsuit Regarding First Amendment and Off-Label Promotion Issues
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 … Continue Reading
First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA
The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved label indications. The Amarin Pharm v. FDA litigation has garnered a good deal of attention, and after Amarin and the FDA … Continue Reading
Off-Label Promotion And The First Amendment Updates
Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist. The FDA has announced a two-day public hearing on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” In-person … Continue Reading
A Proposed End to “Amarin Pharm v. FDA” has FDA Agreeing to Abide by District Court’s Order
We have been closely following Amarin Pharm, Inc. v. FDA with respect to the preliminary injunction granted by the Southern District of New York that prohibited the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa. We’ve also been following the similar Pacira Pharm., Inc. v. FDA case, which … Continue Reading
