--- title: Court Ruling Could Loosen FDA Rules on Drug Marketing description: The preliminary injunction prevents the FDA from blocking actions by Amarin Corp. marketing its fish oil Vascepa pill for off-label usage. canonical: https://time.com/3989516/fda-ruling-drug-marketing-amarin-vascepa/ author: Julia Zorthian article:opinion: false article:content_tier: free article:published_time: 2015-08-07T21:07:19.000Z article:modified_time: 2026-02-22T10:01:02.298Z article:section: Health og:title: Court Ruling Could Loosen Rules on Drug Marketing og:description: The FDA is blocked from stopping a drug company's marketing claim og:url: https://time.com/3989516/fda-ruling-drug-marketing-amarin-vascepa/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/bltde093bcdab65f2d0/6988d9b9bc6cfc69913e2a3c/time-logo.jpg?branch=production og:image:width: 1200 og:image:height: 675 og:image:alt: TIME og:type: article twitter:card: summary_large_image twitter:title: Court Ruling Could Loosen Rules on Drug Marketing twitter:description: The FDA is blocked from stopping a drug company's marketing claim twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/bltde093bcdab65f2d0/6988d9b9bc6cfc69913e2a3c/time-logo.jpg?branch=production --- # Court Ruling Could Loosen Rules on Drug Marketing  by [Julia Zorthian](https://time.com/author/julia-zorthian/)  ## Julia Zorthian Aug 7, 2015 9:07 PM UTC  by [Julia Zorthian](https://time.com/author/julia-zorthian/)  ## Julia Zorthian Aug 7, 2015 9:07 PM UTC A federal judge [ruled](http://www.bloomberg.com/news/articles/2015-08-07/judge-s-ruling-lets-drugmaker-promote-use-without-fda-approval) Friday against the Food and Drug Administration’s attempt to stop a drug company from telling doctors about unapproved uses for one of its products, in a case with potentially significant implications for the agency’s ability to regulate drug marketing. The [preliminary injunction](http://www.nysd.uscourts.gov/cases/show.php?db=special&id=478) prevents the FDA from blocking actions by Amarin Corp. in marketing its fish oil Vascepa drug for off-label usage. The drug company sued the FDA, framing the issue as a First Amendment violation. The judge ultimately ruled that it was unconstitutional for the FDA to impose off-label promotion restrictions for the drug when Amarin could provide evidence backing its promotional claims. The FDA tried to restrict Amarin from marketing that Vascepa could benefit patients with “persistently high triglycerides,” since the drug is only approved for the more severe “very high triglycerides” level. “Although recognizing that the FDA’s policies advanced a substantial government interest in requiring manufacturers to submit supplemental applications for new drug uses,” the district judge wrote in his opinion, “the court held the FDA’s restrictions on such speech were more extensive than necessary, and thus breached the First Amendment.” ```json [{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://time.com/3989516/fda-ruling-drug-marketing-amarin-vascepa/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/3989516/fda-ruling-drug-marketing-amarin-vascepa/"},"headline":"Court Ruling Could Loosen Rules on Drug Marketing","datePublished":"2015-08-07T21:07:19.000Z","dateModified":"2026-02-22T10:01:02.298Z","description":"The FDA is blocked from stopping a drug company's marketing claim","url":"https://time.com/3989516/fda-ruling-drug-marketing-amarin-vascepa/","keywords":["FDA"],"thumbnailUrl":"","author":[{"@type":"Person","name":"Julia Zorthian","jobTitle":null,"url":"https://time.com/author/julia-zorthian/"}],"articleSection":"Health","image":[],"publisher":{"@type":"Organization","name":"Time","url":"https://time.com/","logo":{"@type":"ImageObject","url":"https://time.com/images/logo.png","width":528,"height":156},"foundingDate":"March 3, 1923","sameAs":["https://www.facebook.com/time","https://www.instagram.com/time/?hl=en","https://twitter.com/time","https://www.pinterest.com/timemagazine"]}},{"@context":"https://schema.org","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"item":{"@id":"/section/health/","name":"Health"}},{"@type":"ListItem","position":2,"item":{"@id":"https://time.com/3989516/fda-ruling-drug-marketing-amarin-vascepa/","name":"Court Ruling Could Loosen Rules on Drug Marketing"}}]}] ```