The nation’s highest court has declined to hear a dispute over whether the U.S. International Trade Commission (ITC) should have investigated a complaint brought by a pharmaceutical company over the legality of certain “synthetically produced omega-3 products” promoted as dietary supplements.
The Supreme Court on Monday denied Amarin Pharma Inc.’s petition for a writ of certiorari, ending the company’s hopes of compelling the ITC to act on its 2017 complaint.
Amarin is the maker of Vascepa, a pharmaceutical drug synthetically derived from fish oil, and in comments filed July 15 with FDA, the company described the drug's active ingredient, icosapent ethyl, as "highly purified and highly concentrated EPA in the ethyl ester chemical form."
"Amarin intends to continue to pursue other paths to protect the Vascepa franchise against this class of synthetically produced omega-3 products," the company stated on an investor relations webpage in response to the Supreme Court's decision.
Amarin's 2017 complaint with the ITC challenged the legality of omega-3 products marketed as dietary supplements and predominantly containing EPA in either ethyl ester or re-esterified form. Amarin alleged the companies’ products were 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 federal Lanham Act and standards the FDCA established.
The Council for Responsible Nutrition (CRN), a trade group representing the dietary supplement industry, applauded the Supreme Court's denial of Amarin's petition to review the case.
"CRN has been fighting this case from the beginning to maintain FDA’s exclusive jurisdiction over the FDCA, protect legitimate manufacturers selling fish oil supplements, and ensure consumers have access to concentrated omega-3 fish oil supplements without a prescription," said Megan Olsen, assistant general counsel to CRN, in a statement.
FDA asked ITC to refrain from an investigation because the agency hadn’t reached “final conclusions” whether the products targeted by Amarin were unapproved new drugs rather than dietary supplements. And in June 2018, a government 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.
Representatives for FDA and ITC declined to comment on the Supreme Court's denial of Amarin's petition for a writ of certiorari.
Kevin Bell, a partner in Washington with the law firm Arnall Golden Gregory LLP, described as "significant" the impact of the Amarin case on future cases at the ITC.
"The ITC is a very powerful forum to litigate unfair competition claims, weaponized with the most powerful remedy—exclusion from importation into the United States," Bell said in an email for this article. "While it showed deference to the FDA in Amarin, both the ITC as well as the Federal Circuit on Appeal, clearly stated that it was due to the fact that Amarin’s claims, as pled, relied on an 'unapproved drug' status that had not been considered by the FDA."
On the other hand, the lawyer observed the Amarin case "does not bar an ITC unfair competition or false advertising investigation based on an issue that the FDA has considered and decided," such as an acknowledgement without objection of a new dietary ingredient (NDI) notification. Manufacturers of dietary supplements that have successfully submitted NDI notifications to FDA have complained about so-called knockoff ingredients being imported into the United States.
"I believe the ITC would initiate a 337 investigation of unfair competition and false advertising, which could include factual allegations by an NDI holder that the unfair competition includes parties knowingly importing [an] ingredient not covered by the NDI," Bell explained. "The FDA has already acknowledged the NDI status of the stakeholder’s ingredient."
"Under existing case law," Bell added, the ITC would not be "usurping the FDA’s authority in making its determination of unfair competition."
In its petition filed with the Supreme Court, Amarin predicted the Federal Circuit’s decision could have an “enormous” impact on industries subject to FDA’s authority.
“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,” Amarin wrote.
The Supreme Court's denial of Amarin's petition reflected a victory for several prominent dietary supplement firms targeted by Amarin, including (among others) Nordic Naturals Inc., Pharmavite LLC and DSM Nutritional Products LLC. Attorneys who represented the companies did not immediately respond to requests for comment.
"CRN is pleased to see that the Federal Circuit’s decision will be upheld," Olsen said.
In an amicus brief submitted last year to the Federal Circuit, 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.”