ITC informed the pharmaceutical company via a letter sent to its lawyers on Friday. The decision has yet to post formally on ITC’s website. ITC hinged its decision on the competitive aspects of Amarin’s request, and did not touch on the drug maker’s allegation that certain high concentrate ethyl ester or re-esterified forms of fish oil, which appear in thousands of dietary supplements on the market, are not dietary ingredients at all but should be consider unapproved drugs.
“Amarin’s complaint does not allege an unfair method of competition or an unfair act cognizable under 19 U.S.C. § 1337(a)(1)(A), as required by the statute and the Commission’s rules. The Commission notes that the Lanham Act allegations in this case are precluded by the Food, Drug and Cosmetic Act (“FDCA”). The Commission also notes that the Food and Drug Administration is charged with the administration of the FDCA,” the ITC letter stated.
Last week FDA took the unusual step of writing to ITC to ask it to set aside the case because deciding to commence an investigation would diminish FDA’s authority to regulate the dietary supplement sector. In particular, the complaint would muddy the waters in the highly charged issue of which ingredients that are currently being sold are in fact New Dietary Ingredients for which no notification was filed before they came on the market, thus becoming by definition adulterated and falling into the category of ‘unapproved drugs.’
Amarin’s market problem
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).
Amarin has only the one product and has been fighting hard to protect the market for the drug. 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. Last year the drug maker prevailed in a free-speech case against FDA to allow it to market the drug for these off label cardiovascular disease indications. The company has a long-term cardiovascular disease risk reduction study called REDUCE-IT in progress with results expected in mid 2018.
Industry sources: ITC’s decision was correct
“This is a significant win for the industry,” Adam Ismail, executive director of the Global Organization for EPA and DHA Omega-3s told NutraIngredients-USA. “I don’t expect it to be the end of the matter, though; Amarin could still pursue it by filing a citizen’s petition with FDA.”
Todd Harrison, an attorney with the law firm Venable which sent a response to ITC on behalf of one of the defendants in the case, Nordic Naturals, concurred with Ismail.
“This was the correct decision,” Harrison said. “We were very confident after FDA took the unusual step of sending its letter. But I agree this probably only the beginning. They could try to press the case in a federal court or they could go the citizen’s petition route.”
Harrison noted there is a precedent for having a dietary ingredient retroactively declared a drug via a citizen’s petition to FDA in 2009 in the case of pyridoxine, a form of vitamin B6. But he said the arguments are potentially more tangled in this case. Are these ingredients really drugs because some fish oils were studied as drugs back in the 1980s? Do the concentration steps used to make them really render them ‘synthetic?’ Are they different enough from their low concentrate fish oil forebears to be considered as New Dietary Ingredients? And the biggie: Would this open the door to a slew of similar actions? FDA’s letter made it clear that in the agency’s opinion these issues should be resolved within FDA itself, not piecemeal as a set of ITC decisions.
“I think it was a bold step on Amarin’s part to make these arguments but I think it was a miscalculation on their part, too. I don’t think the company’s counsel fully appreciated the concerns about their arguments,” Harrison said.
“In short we’re very supportive and also not all that surprised, in addition to the case law that clearly shows that the active moieties are the same whether the supplement or the drug, and DS companies aren’t making disease claims as prescription drugs are so how is it misleading? Moreover, Amarin’s EPA is one of the higher cost per dose unit medical products out there and payers are starting to wonder why not just steer people towards supplements with the same specifications. The take home is this, however, for the industry, we have to stay involved and vigilant because even in what is considered a time of more limited regulation, there are never a shortage of bad ideas out there,” said Dan Fabricant, PhD, executive director of the Natural Products Association.
“CRN extends its appreciation to ITC for its decision to reject a complaint filed by Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Ltd. against omega-3 companies. In doing so, ITC recognizes that, under the Food, Drug & Cosmetic Act, FDA has exclusive authority to make the determination requested by Amarin—and, for that, we are grateful. This decision is a victory not only for legitimate manufacturers that sell legal fish oil supplements, but for consumers depending on accessible, affordable products that benefit their health and well-being,” said Steve Mister, president and CEO of the Council for Responsible Nutrition.
Amarin declined to comment on the decision.