Amarin, maker of the fish oil-based triglyceride lowering drug Vascepa (icosapent ethyl), says it plans to file a citizen petition “within weeks” in an attempt to block companies from marketing products containing similar synthesized ingredients as dietary supplements.
Icosapent ethyl, the active ingredient in Vascepa, is a highly purified form of eicosapentaenoic acid (EPA) that was first approved by the US Food and Drug Administration (FDA) in 2012 to lower triglyceride levels in adult patients with hypertriglyceridemia. Amarin is currently seeking approval for the drug to reduce cardiovascular risk in certain patients and on Wednesday announced a $400 million public offering.
Amarin announced its intent to file a citizen petition in comments submitted Monday to the public docket for a recent FDA public meeting on responsible innovation in dietary supplements.
The comments come after Amarin’s request for the International Trade Commission (ITC) to investigate a similar complaint was rejected, with the Federal Circuit denying Amarin’s appeal of the decision last May. The comments also follow FDA’s announcement last month that it “does not intend to object to the use of certain qualified health claims” stating that EPA and docosahexaenoic (DHA) omega-3 fatty acids in food or dietary supplements may reduce the risk of hypertension and coronary heart disease.
According to Amarin, companies marketing dietary supplements containing synthetic EPA “unfairly compete with legitimate drugmakers” and “unlawfully bypass the ‘new drug’ approval process.”
“Amarin believes that synthetic copies and slightly altered versions of FDA-approved prescription omega-3 drugs are being unlawfully marketed as dietary supplements,” the company writes.
While Amarin says its drug Vascepa is made from “common fish oil,” the company claims it has spent more than $500 million to develop the drug and that “it is not possible to produce natural fish oil” with a combined concentration of EPA and docosahexaenoic acid (DHA) in excess of 30% without chemical synthesis.
The distinction between natural and synthetic ingredients is key to Amarin’s argument, which relies on the definition of dietary supplements under the 1994 Dietary Supplement Health and Education Act (DSHEA).
Under DSHEA, dietary supplements must include a dietary ingredient, such as a vitamin; mineral; herb or other botanical; amino acid; “a dietary substance for use by man to supplement the diet by increasing total dietary intake”; or a “concentrate, metabolite, constituent, extract, or combination” of any of the previously listed types of ingredients.
Amarin points out that while synthetic vitamins, minerals and amino acids “are not excluded” from the definition of dietary ingredient, the company argues that other synthetic ingredients derived from natural substances “are typically excluded” from being considered dietary ingredients.
Amarin also notes that FDA has rejected previous attempts to commercialize synthetic substances as dietary ingredients. In 2011, FDA rejected a citizen petition from OVOS Natural Health for its synthetic homotaurine product based on the agency’s determination that “homotaurine is not a dietary ingredient” as it is not an amino acid “nor does it fit under any of the other dietary ingredient categories listed in section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act.”