Amarin Pharma, Inc. v. U.S. Food and Drug Administration

Pharmaceutical manufacturer Amarin Pharma, Inc. (Amarin) (plaintiff) sought approval from the Food and Drug Administration (FDA) (defendant) for two uses of Amarin’s triglyceride-lowering drug, Vascepa. Specifically, Amarin sought FDA approval to market Vascepa for (1) treating adult patients with very-high-triglyceride levels (i.e., levels above 500 mg/dL of blood) and (2) a widely recognized off-label use of treating patients with persistently high triglyceride levels (i.e., levels between 200 and 499 mg/dL of blood while patients were already receiving statin therapy). An FDA-approved study called the ANCHOR study indicated that Vascepa was effective in reducing persistently high triglycerides. Vascepa was also recognized as safe for use in patients with elevated triglyceride levels, and the FDA allowed the sale of a dietary supplement that was chemically similar to Vascepa. However, the FDA refused to approve the off-label use of Vascepa and refused Amarin’s request to include the results of the ANCHOR study on Vascepa’s label. The FDA asserted that approval was being denied because recent scientific studies were unclear regarding whether reducing triglyceride levels in patients with persistently high triglycerides would reduce those patients’ cardiovascular risk. The FDA threatened Amarin with an action for misbranding if Amarin marketed Vascepa for the off-label use. Amarin sued the FDA in federal district court, asserting that the FDA’s threat of a misbranding action prevented Amarin from making truthful statements to healthcare professionals regarding Vascepa and the ANCHOR study. Amarin’s complaint sought preliminary relief asking the court to confirm that Amarin had a First Amendment right to initiate and engage in discussions with doctors to share true and nonmisleading information about off-label use of Vascepa. In considering Amarin’s request, the court considered Amarin’s likelihood of success on the merits of the First Amendment claim.