A federal judge ruled 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 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.”
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Write to Julia Zorthian at julia.zorthian@time.com