Amarin had requested the investigation, alleging that some formulations of fish oils violate its patents. Amarin had alleged that certain high concentrate ethyl ester and reesterified triglyceride forms of fish oils, which appear in thousands of omega-3 dietary supplements that are on the market, are in fact unapproved drugs. Amarin hinged this allegation on the idea that these forms of fish oils are different from the forms that first appeared on the market, and are chemically different enough (‘chemically altered’ in regulatory parlance) that they are in fact New Dietary Ingredients for which no notification has been filed. With the extension, a ruling from the ITC on whether the case will go forward is expected on Oct. 27.
Amarin moves to protect its market
According to Amarin’s complaint, the Dublin, Ireland-based company had spent more than $200 million bringing its prescription drug Vascepa to market. The drug, which is refined from fish oil, provides a one-gram dose of eicosapentaenoic acid (EPA). The company only has the one product, and sales, while robust from a dietary supplement industry perspective, have been less than hoped for, especially considering the massive investment. According to sources in the pharmaceutical industry, the indication for which Vascepa was approved to treat—hyperlipidemia, or a condition in which patients have abnormally high levels of triglycerides in their blood—is far narrower than what the drug maker was hoping for. The drug was studied to treat broader descriptions of cardiovascular disease risk, but FDA ruled that the conclusive evidence only applied to the one indication.
Attempt to corner market?
Industry stakeholders have asked ITC to set aside the potential investigation. Chief among these is the Food and Drug Administration, which sent a letter to the commission last week asking it to back off. FDA’s reasoning is that this is primarily a question of regulation, not trade, and if ITC takes it up, it will infringe on FDA’s exclusive right to enforce the Food, Drug & Cosmetic Act. Some questions, such as when do processing changes to a legacy ingredient render it into an NDI, are unresolved, the agency admitted. But deciding these piecemeal through hearings before commissions and courts is an untenable way to go about resolving these issues, the agency asserted.
Other stakeholders have made themselves heard as well. Both the Global Organization for EPA and DHA Omega-3s (GOED) and the Council for Responsible Nutrition have asked ITC not to take the case. In their view, these forms of fish oils have been in the market for many years, and Amarin’s request to ITC was seen as an attempt to corner the market in high EPA products from fish oil, a move that would deprive consumers of access to legal dietary ingredients.