As we reported last August, US District Judge Paul Engelmayer ruled that Amarin Pharma has a First Amendment right to truthfully promote its prescription drug Vascepa for off-label uses. August 10, 2015, article. Shortly afterward, Amarin and the government
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Amarin, FDA talking settlement
Amarin wins injunction against FDA over off-label marketing
In June, we wrote about Amarin Pharma’s suit asking a federal court to hold that the FDA’s prohibitions on off-label promotion as applied to “speech Amarin proposes to make and [doctors] wish to receive” about its product Vascepa® “are unconstitutional.”…
11th Cir. holds “skim milk” label protected by 1st Amendment
In a case with potentially significant ramifications for regulatory oversight of the labeling and advertising of foods and pharmaceuticals, the Eleventh Circuit held the First Amendment precluded the Florida Department of Agriculture’s Bureau of Dairy Industry (the “Florida Bureau”) from…
FDA seeks to appease drug company in off-label marketing dispute
The FDA has long treated off-label marketing – the promotion of drugs for uses that have not received FDA approval – as evidence of intent to violate the “misbranding” provisions of the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C.…