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
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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
What Comes Next In Amarin Pharm v. FDA?
The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug Vascepa—understandably has been big news, analyzed here and elsewhere. Some are asking whether the FDA will pursue appellate review of the decision. An indication about … Continue Reading
Amarin Obtains Preliminary Injunction Against FDA Regarding Off-Label and First Amendment Issues
In our prior posts about Amarin Pharma, Inc. v. FDA, we wondered what the Southern District of New York would make of Amarin’s request for an order prohibiting the FDA from taking enforcement actions against it over speech regarding “off-label” uses of its prescription drug, Vascepa. Although Vascepa is regulated as a drug, equivalent products … Continue Reading
Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment
Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses. We provided links to amicus briefs by the Pharmaceutical Research and Manufacturers of America and the Washington … Continue Reading
FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit
As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses. As we noted, on June 8, 2015, … 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
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
Change Coming to FDA’s “Intended Use” Regulations?
Over at the Drug And Device Law Blog, our colleagues call attention to proposed changes to the “intended use” regulations for prescription drugs and devices, 21 C.F.R. §201.128 and 21 C.F.R. §804.1, somewhat hidden within a proposed rule regarding tobacco published in the Federal Register on September 25, 2015. As the FDA explained, the changes … Continue Reading
FDA Sued By Drug Manufacturer Over Constitutional Right To Discuss Off-Label Uses
The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices. In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent the drug- and device-approval processes. … Continue Reading
