Irish drug maker Amarin has filed a declaratory judgment action against the FDA contending its off-label regulations violate the First Amendment. The complaint, filed in the U.S. District Court for the Southern District of New York, also seeks a declaration that the FDA is violating the Due Process clause of the Fifth Amendment by failing to provide clarity on its position regarding off-label promotion.
The FDA approved Amarin’s drug, Vascepa, to treat very high triglyceride levels. Following additional studies, Amarin sought an additional indication for the drug for treatment of merely high triglyceride levels. The FDA shot Amarin down, relying on studies that call into question whether lower triglycerides actually improves heart health.
Amarin contends that the First Amendment protects its right to share truthful, non-misleading information with doctors, specifically, Vascepa’s efficacy in lowering triglycerides. Such off-label promotion could result in civil or criminal penalties due to its violation of FDA regulations.
Amarin proposes using the same promotional language the FDA permits on omega-3 fatty acid nutritional products.