FAN 71.2 (First Amendment News) Floyd Abrams prevails in off-label drug case — Court grants preliminary injunction
[Today a] U.S. judge . . . barred the U.S. Food and Drug Administration from stopping Irish drugmaker Amarin Corp from promoting its fish oil drug for off-label uses, saying the company is protected by the First Amendment.The preliminary order by U.S. District Judge Paul Engelmayer in Manhattan means Amarin can promote its Vascepa pill to doctors for off-label use as long as it does so truthfully. Friday’s decision is a preliminary injunction, not a final order. However, Engelmayer said in granting the injunction that Amarin was likely to prevail. –– Reuters, Aug. 7, 2015
Four days ago I wrote a post titled “Amarin v. FDA –Important Commercial Speech Case May be Decided Soon.”
Well, that case was decided today. In a detailed and nuanced 71-page opinion, U.S. District Judge Paul A. Engelmayer ruled in the Plaintiffs’ favor and granted a preliminary injunction. Floyd Abrams was the lead counsel for Amarin.
Recall the respective claims made by the parties:
→ Plaintiff’s Claim: “Amarin Pharma wants to provide healthcare professionals with truthful, non-misleading information about its prescription drug Vascepa®, and four doctors who want to receive that information, as they determine when and whether to prescribe that drug. If Amarin provides that information, however, it is at high risk of criminal and civil sanctions being sought against it by the United States.”
→ Government’s Claim: “Plaintiffs seek a court order that would allow Amarin to distribute its drug Vascepa under circumstances which could establish that Amarin intends an unapproved new use for Vascepa, i.e., a use for which FDA has not determined that the drug is safe and effective. But Plaintiffs’ legal arguments strike at the very heart of the new drug approval process, and a court decision in Plaintiffs’ favor has the potential to establish precedent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses.”
→ District Court Holding
The Court has held that Amarin’s proposed communications, as modified herein, are presently truthful and non-misleading. But the dynamic nature of science and medicine is that knowledge is ever-advancing. A statement that is fair and balanced today may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired. The Court’s approval today of these communications is based on the present record. Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.
→ District Court’s order:
The Court grants Amarin’s application for preliminary relief. Specifically, the Court declares that:
(1.) Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa, i.e., to treat patients with persistently high triglycerides, and under Coronia, such speech may not form the basis of a prosecution for misbranding; and
(2) Based on the information presently known, the combination of statements and disclosures that Amarin proposes to make to doctors relating to the use of Vascepa to treat persons with persistently high triglycerides, as such communications have been modified herein,* is truthful and non-misleading.
→ See also “Court Approves Amarin (AMRN) to Tell Doctors About Off-Label Vascepa Usage,” StreetInsider.com, Aug. 7, 2015 (listing approved statements).