The Council for Responsible Nutrition (CRN; Washington, DC) submitted two filings this week with the United States International Trade Commission (ITC), urging the ITC to reject a complaint filed on August 30 by omega-3 pharmaceutical firm Amarin Pharma Inc. Amarin’s complaint, which named 18 EPA omega-3 fish oil companies, alleged that synthetically produced omega-3 dietary supplements composed predominantly of EPA in either ethyl ester or re-esterified form are synthetic and thus are not considered “dietary ingredients” under Section 201(ff)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act). Amarin requested that the ITC conduct an investigation into these omega-3 products. In its comments to the International Trade Commission, filed on September 14, CRN argued that Amarin was “financially motivated” to expand its near monopoly of its Vascepa omega-3 EPA drug for lowering triglycerides over a subset of omega-3 products; if successful, CRN says, Amarin’s complaint would make it much more difficult and costly for consumers to access those non-pharmaceutical products.
The first of CRN’s filings argues that Amarin’s complaint runs counter to public interest in that its desired prohibition of the importation or sale of ethyl ester or re-esterified omega-3 supplements would limit consumers’ ability to purchase such supplements without a prescription. If successful, not only would the complaint affect the cost and availability of omega-3 supplements, CRN says, but it would also “further convert a highly competitive market to an Amarin monopoly.”
The filing states: “Indeed, Amarin acknowledges that the typical monthly cost of obtaining their product Vascepa is $200, excluding the cost of a doctor’s visit to obtain a prescription. While some of this cost may be offset by insurance, the healthy consumers who take concentrated Omega-3 products for a condition other than lowering triglyceride levels would no longer have access to these products over-the-counter, or at all. Concentrated omega-3 dietary supplements can be purchased, without a prescription, from retailers for as little as $10-20 per month.”
The filing further states that these omega-3 dietary supplements should not be considered a threat to Amarin’s Vascepa drug because consumers who take omega-3 supplements do not necessarily take supplements for the same reason pharmaceutical users take Vascepa (to lower high triglycerides).
Nutritional Outlook spoke with Duffy MacKay, ND, senior vice president, scientific and regulatory affairs, CRN, following Amarin’s initial complaint. He told Nutritional Outlook that he believed Amarin to be attempting to “stamp out the competition.” In a new press release from CRN, Steve Mister, president, CEO, CRN, echoed MacKay’s sentiments. “This appears to be a case of a company seeking a market monopoly that would deprive both legitimate manufacturers of selling legal fish oil supplements and consumers of having access to products that benefit their health and well-being,” he said.
In addition, CRN says, there are substantial legal deficiencies in Amarin’s complaint that should delegitimize the company’s request for an ITC investigation. This is the focus of CRN’s second filing to ITC, which narrows in on Amarin’s claims that “concentrated omega-3 supplements have not been recognized as dietary supplements by the FDA.” CRN’s complaint notes that it is first and foremost the jurisdiction of FDA, not the ITC, to determine whether or not the omega-3 products in question are legal dietary supplements. On this basis, CRN’s complaint says, the ITC should reject Amarin’s complaint and defer to the FDA.
In the CRN press release, Rend Al-Mondhiry, associate general counsel, CRN, stated, “Amarin is inappropriately seeking to bypass the U.S. Food and Drug Administration’s (FDA) rightful authority to make this determination by filing its complaint with the ITC,” she said. “Contrary to Amarin’s assertions, FDA has exclusive authority to make this determination.”
The CRN complaint further states that if FDA were indeed to determine that the omega-3 supplements in question are not dietary supplements, that would then give the ITC legitimate grounds for an investigation. “The Commission should, therefore, defer to the FDA to determine whether the Proposed Respondents’ products violate the FDCA. If the FDA, in its proper role, determines as a legal matter that Amarin’s interpretation of the FDCA and its regulations is correct, Amarin may at that point have a viable claim under Section 337. Absent that determination, however, Amarin’s complaint fails to state a claim under Section 337 and institution of an investigation would be inappropriate.”
In asking the ITC to make a legal determination on Amarin’s complaint, CRN says, Amarin has crossed a “legal boundary.”