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Amarin and FDA settle off-label suit

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 entered settlement talks. August 31, 2015 update. We are now able to report that on March 8, … Continue reading

Amarin, FDA talking settlement

In a letter dated August 28, an attorney representing Amarin Pharma, Inc. advised the judge overseeing Amarin’s case against FDA, that “The parties have agreed to explore the possibility of settlement of this matter.” In our recent post, we analyzed U.S. District Judge Paul Engelmayer’s August 7th decision granting Amarin’s motion for preliminary injunction against the … Continue reading

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.” June 11, 2015 article. On August 7, the court ruled that Amarin has a constitutional … Continue reading

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 prohibiting a dairy company’s use of the phrase “skim milk” to describe its “all-natural” milk … Continue reading

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. § 301 et seq. According to the FDA, pharmaceutical manufacturers and their representatives may not … Continue reading