Amarin Pharma Inc. has gone to court in the nation’s capital seeking an order that would require the U.S. International Trade Commission (Commission) to investigate allegations that marketers of certain fish oil supplements are violating federal law.
In October, the Commission declined to open an investigation into Amarin’s complaint, dealing a victory to several dietary supplement companies that otherwise would have been required to defend their products.
The controversy, however, is not over. On Dec. 1 in the U.S. Court of Appeals for the Federal Circuit, Amarin filed a petition for review of the Commission’s decision and a petition for a writ of mandamus, requesting consolidation of the two cases.
The pharmaceutical company is seeking a writ of mandamus, reversing the Commission’s decision and directing the agency to institute an investigation. Amarin has challenged the legality of certain “synthetically produced omega-3 products" being promoted as dietary supplements.
In declining to commence an investigation, the Commission advised Amarin in a letter that the company failed to “allege an unfair method of competition or an unfair act cognizable under" the Tariff Act of 1930, as the statute and Commission rules require.
“The Commission also notes that the Food and Drug Administration is charged with the administration of the FDCA [Federal Food, Drug and Cosmetic Act]," Lisa R. Barton, secretary to the Commission, wrote in an Oct. 27 letter to Jeffrey M. Telep of the law firm King & Spalding LLP, which represented Amarin in its complaint.
However, Amarin’s lawyers contended the Commission abused its discretion for three reasons.
First, Amarin advised the appeals court its complaint properly invoked the Commission’s jurisdiction, so the agency had no discretion not to open an investigation.
Second, Amarin leaned on a decision from the U.S. Supreme Court to refute the premise that the Federal Food, Drug & Cosmetic Act (FDCA) bars Amarin’s allegations under the Lanham Act.
“The Supreme Court has rejected the view that FDA has exclusive authority over the labeling of FDCA-regulated products, holding that ‘Congress did not intend the’ FDCA ‘to preclude Lanham Act suits’ alleging false and misleading advertising," Amarin wrote, quoting a 2014 Supreme Court decision involving POM Wonderful and Coca-Cola Co.
FDA had asked the Commission to refrain from opening an investigation because it had not determined whether the products subject to the complaint are drugs or dietary supplements. FDA officials also asserted Amarin has no private right of action under the FDCA.
By deferring to FDA, the Commission erred, establishing a third reason the agency abused its discretion, according to Amarin.
“Nothing in Amarin’s complaint requires the Commission to enforce the FDCA or resolve any issue that would require scientific expertise," the pharmaceutical company declared in its petition filed with the Washington-based appeals court. “The remedies Amarin seeks are unique to Section 337 [of the Tariff Act of 1930]. And the statutory terms ‘drug’ and ‘dietary supplement’ carry meanings that are well understood in the market, and applying them to the facts is a straightforward exercise within the Commission’s authority under Section 337, not a complicated scientific inquiry."
Amarin added there is a process under the law by which FDA could participate in an investigation if its scientific expertise was required.
The Commission did not immediately respond to a request for comment on the appeal.
Background of Complaint
In a 105-page complaint filed on Aug. 30 with the Commission, Amarin Pharma Inc. and Amarin Pharmaceuticals Ireland Ltd. alleged “synthetically produced omega-3 products" being promoted as dietary supplements are unapproved new drugs under the FDCA. Therefore, the false labeling of the products, Amarin asserted, constitutes 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.
At issue in Amarin’s original complaint: the legality of omega-3 products predominantly containing eicosapentaenoic acid (EPA) in either ethyl ester or re-esterified form.
The omega-3 products containing EPA in the forms subject to Amarin’s complaint have been on the market for many years, and FDA hasn’t had a problem with them, according to Duffy MacKay, senior vice president of scientific and regulatory affairs with the Council for Responsible Nutrition (CRN). (INSIDER interviewed MacKay in September after Amarin’s complaint was filed.)
Losses from Pharmaceutical Drug
Amarin’s grievance symbolizes the occasional bitter turf wars between the pharmaceutical and dietary supplement industries.
In July 2012, Amarin’s drug Vascepa received FDA approval in the United States 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.
As is typical of pharmaceutical companies that introduce a new drug, Amarin noted, Vascepa has compiled heavy losses. However, the respondents’ unfair practices, Amarin asserted, have exacerbated the losses—diminishing its market share and contributing to “lost profits and to the price erosion of Vascepa."
In the three months ended Sept. 30, 2017, Amarin Corporation plc (NASDAQ: AMRN) reported a net loss of $10.8 million on $47.1 million in U.S. net product revenue from Vascepa sales. Through the first nine months of 2017, Amarin reported a net loss of $45.4 million on net product revenue of $126.3 million.
Amarin Pharma Inc. and Amarin Pharmaceuticals Ireland Ltd. are wholly-owned subsidiaries of Amarin Corporation plc.
In the “Risk Factors" section of its quarterly 10-Q filing with the Securities and Exchange Commission, Amarin noted dietary supplement companies also market omega-3 fatty acids.
“We cannot be sure physicians will view the pharmaceutical grade purity and tested efficacy and safety of Vascepa as having a superior therapeutic profile to untested and largely unregulated omega-3 fatty acid dietary supplements," the company said in its regulatory filing.
Amarin also said FDA hasn’t fully enforced against what it considers illegal claims by manufacturers of omega-3 fatty acid products. It referenced its complaint filed with the Commission, but acknowledged such efforts may not be successful.