Amarin Pharma Inc. in 2017 launched a broad attack against marketers of fish oil supplements over what it described as “synthetically produced omega-3 products” that are unapproved new drugs.
But the U.S. International Trade Commission (ITC) declined to investigate Amarin’s complaint in a decision that was affirmed this year by an appeals court in Washington.
Amarin, the manufacturer of the pharmaceutical drug Vascepa, has devised a new strategy in its long-running grievances against the dietary supplement sector. It intends to file a citizen petition with FDA “within weeks,” according to comments filed July 15 with the agency.
In the forthcoming citizen petition, Amarin revealed, it will assert "a product with synthetic eicosapentaenoic acid ("EPA")—that is, chemically concentrated forms of EPA that are not found in natural substances—cannot be lawfully marketed as a dietary supplement."
The biopharmaceutical company disclosed its plans to file a citizen petition in comments filed with FDA regarding a docket, “Responsible Innovation in Dietary Supplements.”
Amarin is aiming to protect its investment in Vascepa, which FDA approved in 2012 for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, a condition commonly found in patients with coronary heart disease.
Vascepa, which Amarin spent more than $500 million to develop, “is synthetically derived from common fish oil, and its active ingredient—icosapent ethyl—is highly purified and highly concentrated EPA in the ethyl ester chemical form,” the company wrote in its comments.
The comments flagged supplements that contain concentrated synthetic EPA and/or omega-3 in ethyl ester or re-esterified form. The products, Amarin said, are synthetic copies or analogs of drugs and have circumvented “the ‘new drug’ approval process.”
Amarin proclaimed synthetic omega-3 products marketed as dietary supplements fail to qualify as “dietary ingredients” and don’t meet the definition of a “dietary supplement” based on an “exclusionary clause” in federal law related to articles first approved or studied as drugs.
Companies can lawfully market these types of products “by studying the drugs in adequate and well-controlled clinical trials and submitting the data to FDA through the ‘new drug’ approval process,” Amarin wrote in its comments with FDA. “If FDA fails to enforce the statutory requirements by not robustly and fairly policing the synthetic/natural distinction, it is effectively enabling unlawful unapproved ‘new drugs’ to masquerade as dietary supplements. That failure to enforce would disincentivize drug innovation and expose the public to untested products, putting them at risk.”
In an email, Amarin said its comments filed with FDA are "clear" and "extensive" and "speak for themselves." Its filing was 29 pages long.
Asked to comment on Amarin’s planned citizen petition, Julia Mangia, an FDA spokeswoman, said the agency will review the document “and respond directly to the petitioner” once it receives the petition.
On May 1, the U.S. Court of Appeals for the Federal Circuit affirmed the ITC’s decision to not investigate Amarin’s complaint.
Amarin’s claim was based on establishing violations of the Federal Food, Drug & Cosmetic Act (FD&C), but “FDA has not taken the position that the articles at issue do, indeed, violate the” law, the appeals court noted. FDA, the Federal Circuit added, “has not provided guidance as to whether the products at issue properly qualify as ‘dietary supplements.’”
The Council for Responsible Nutrition (CRN), a trade group in Washington representing the supplement sector, applauded the ruling after it was published.
“This decision is significant and beneficial for the dietary supplement industry as it confirmed FDA’s exclusive jurisdiction to interpret and enforce the provisions of the Food, Drug and Cosmetic Act,” Steve Mister, president and CEO of CRN, said in a statement at the time.
“Amarin was seeking to impose restrictions,” Mister added, "that could have created a market monopoly for pharmaceutical companies over a subset of omega-3 products, hindered responsible manufacturers from selling beneficial fish oil supplements and removed consumers’ abilities to buy affordable products that benefit their health and well-being.”