Amarin Pharma Inc. wants the nation’s highest court to hear a long-running dispute with several dietary supplement companies that the U.S. International Trade Commission (ITC) declined to investigate in 2017.
Amarin, the maker of the pharmaceutical drug Vascepa, filed a July 30 petition for a writ of certiorari with the U.S. Supreme Court after an appeals court affirmed ITC’s decision.
It’s Amarin’s last chance in the judiciary to compel ITC to investigate its complaint over the legality of certain “synthetically produced omega-3 products” promoted as dietary supplements, a category of products principally regulated by FDA.
A ruling by the Supreme Court could provide clarity over ITC’s authority to hear complaints involving unsettled issues within FDA’s expertise. A quasi-judicial federal agency, ITC has broad powers over matters of trade, including enforcement of the Tariff Act of 1930.
Representatives for FDA and ITC declined to comment on the petition.
“This case offers the Court an opportunity to restore the private rights of action that Congress granted parties under the Tariff Act of 1930 in order to protect domestic industry from unfair trade practices,” Amarin wrote in its 38-page petition through its outside counsel, Ashley C. Parrish of King & Spalding LLP.
Amarin’s grievances are with several prominent dietary supplement firms, including Nordic Naturals Inc., Nordic Pharma Inc., Pharmavite LLC, DSM Nutritional Products LLC and related DSM entities.
“We are disappointed that Amarin continues to pursue this issue, and we are confident that the U.S. Supreme Court will rule consistent with the ITC and the Federal Circuit Court rulings on this matter,” said Hugh Welsh, president of DSM North America, in an email.
Nordic Naturals, Nordic Pharma and Pharmavite either did not respond to requests or declined comment.
In its 2017 complaint, Amarin alleged the companies’ products above are unapproved new drugs under the Federal Food, Drug & Cosmetic Act (FDCA). Therefore, the false labeling of the products, Amarin argued, constituted an unfair act or method of competition under Section 337 of the Tariff Act of 1930 because the acts violate the Lanham Act and standards the FDCA established.
FDA asked ITC to refrain from an investigation because the agency hadn’t determined whether the products subject to the complaint were drugs or dietary supplements. And in June 2018, a U.S. Department of Justice (DOJ) attorney noted a guidance from FDA on the regulatory classification of these articles would not be forthcoming.
On May 1, the U.S. Court of Appeals for the Federal Circuit affirmed ITC’s decision not to investigate Amarin’s complaint.
“Amarin’s allegations,” the Federal Circuit noted, “are based entirely on violations of the FDCA.” The law precludes such claims, “at least where the FDA has not yet provided guidance as to whether violations of the FDCA have occurred,” the appeals court added.
The Federal Circuit’s decision could have an “enormous” impact on industries subject to FDA’s authority, according to Amarin.
“Because products subject to regulation under the FDCA account for more than [US]$2.5 trillion in consumption—20 cents of every dollar spent by consumers in the United States—the potential impact of the Federal Circuit’s decision is enormous, with entire industries left unable to access the trade remedies that Congress intended,” Parrish wrote in Amarin’s petition with the Supreme Court.
The Federal Circuit’s decision is irreconcilable with the “plain text” of the Tariff Act and the “logic” of the Supreme Court’s decision in POM Wonderful LLC v. Coca-Cola Co., the lawyer argued. In the latter case, the Supreme Court held competitors may bring claims under the Lanham Act challenging food and beverage labels that the FDCA regulates. The Lanham Act authorizes a company to sue a rival for unfair competition stemming from false or misleading advertising.
In affirming ITC’s decision, the Federal Circuit sought to distinguish Amarin’s challenge from the Supreme Court’s ruling in POM Wonderful.
“Although POM Wonderful held that the FDCA does not categorically preclude a Lanham Act claim based on a product (e.g., a label) that is regulated by the FDCA, the Court did not open the door to Lanham Act claims that are based on proving FDCA violations,” the appeals court wrote. “The allegations underlying the Lanham Act claim in POM Wonderful did not require proving a violation of the FDCA itself.”
But the Federal Circuit, Parrish wrote in Amarin’s brief, failed to “address language in POM Wonderful rejecting the view that Congress’s decision to deny parties a right of action under the FDCA reflects an intent to displace private rights of action granted under other federal statutes.”
“It also did not address the investigative role that the [ITC] is supposed to perform when presented with a complaint,” he added. “Nor did it identify any language in the Tariff Act, the FDCA, or any other statute suggesting that Congress intended FDA to be able to block parties from exercising their rights under the Tariff Act when faced with competitive injuries caused by unfair trade practices.”
That Amarin and the supplement companies will square off before the nation’s highest court is a long shot. Of the more than 7,000 cases the Supreme Court is asked to review annually, it accepts 100 to 150, according to the Administrative Office of the U.S. Courts.
Amarin has had other conflicts with the supplement industry. For example, it claimed in 2018 lawsuits that two dietary supplement firms used results from a clinical study known as REDUCE-IT to deceptively and falsely claim their omega-3 products are effective in reducing the risk of cardiovascular disease. Amarin later announced agreements to settle the lawsuits.
"Amarin remains fully committed to defending the Vascepa franchise against any company that seeks to mislead the public and cardiovascular patients in need by selling unapproved drugs cloaked as dietary supplements," the company said in a statement, "or by fraudulently leveraging the landmark REDUCE-IT study results or the REDUCE-IT or Vascepa names as part of marketing their products."
Amarin anticipates hearing by the end of the year or in early 2020 whether the Supreme Court will review the case.
Its petition with the Supreme Court is part of a multi-pronged attack against the supplement sector. In comments filed July 15 with FDA, Amarin disclosed plans to file a citizen’s petition. In the forthcoming 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."
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.”
In an amicus brief submitted last year to the Federal Circuit, the Council for Responsible Nutrition (CRN) and Global Organization for EPA and DHA Omega-3s (GOED) defended ITC’s decision to not investigate Amarin’s complaint.
“Concentrated omega-3 fish oil products are frequently taken by healthy individuals to maintain and promote health—i.e., not as ‘drugs’ intended to treat disease,” the trade associations wrote. “As Amarin acknowledges, the FDA has been aware of concentrated omega-3 products being marketed as ‘dietary supplements’ since the ‘late 1980s.’ Nonetheless, the FDA has not excluded those products from its definition of ‘dietary supplement,’ nor determined that these products violate the standards of the FDCA.”