The ITC had declined to hear the case, which had a wide array of dietary supplement finished goods manufacturers and suppliers as defendants, on Oct. 27. Among the unusual features of the case, and one that surely figured heavily in ITC’s decision, was a communication from the US Food and Drug Administration asking the commission not to take up case, as the issues involved treaded upon issues that, from FDA’s point of view, were fully within its jurisdiction.
Amarin has alleged that certain high concentrate ethyl esters and reesterified triglyceride forms of omega-3 fish oils, which now account for a significant portion of the dietary supplements on the market, violate their patents. The Dublin, Ireland-based drug maker further alleged that these should also be viewed as New Dietary Ingredients for which not NDI Notifications have been filed, thus being adulterated by definition. The question of whether these highly purified forms of fish oils are chemically altered enough from the base versions that safety information for the latter no longer applies is a question that has never been taken up formally by FDA. These ingredients have been on the market for many years, and there are many others like them in other ingredient categories. FDA asked ITC not to take up the Amarin complaint because it would muddy the waters in this highly charged issue, and would diminish FDA’s ability to regulate the sector and could lead to a situation in which these questions would be adjudicated via case law and not regulatory agency action.
The Global Organization of EPA and DHA Omega 3s (GOED) has been closely watching this case, as it could reshape the industry if Amarin is successful. Executive director Adam Ismail told NutraIngredients-USA that this latest wrinkle doesn’t come as a huge surprise, given the corner Amarin finds itself in.
“Amarin noted in an earnings call that they intended to continue to pursue this matter, so it was not really a surprise. Even though appealing ITC non-institution decisions is a rare act, it does not appear that the fundamentals of the case have changed. The industry will have to wait to see how the court rules, but we know this process will go on for some time by going through the Federal courts,” he said.
Fighting hard to protect market
According to Amarin’s initial complaint, the 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.
Amarin said recently it expects its 2017 full fiscal year revenue to come in at between $165 million and $175 million, which in the pharmaceutical world is characterized as “struggling to gain traction” for the drug. With the REDUCE-IT trial underway, which has enrolled more than 8,000 subjects, the company has been reporting R&D expenses of as much as $27 million a quarter in recent quarters.
Chances for success hard to judge
In this latest move, Amarin both filed the notice of appeal and also lodged what’s called a Writ of Mandamus, a fairly unusual procedure in which the complainant asks a court to force an agency to take action on an issue that can be shown to be fully within its legal mandate. Amarin asserts in its writ that ITC is legally bound to take up any properly pleaded complaint. And it rejects FDA’s assertion in its letter to ITC that the Food Drug and Cosmetic Act, and FDA’s sole authority to enforce this law, takes precedence here.
Amarin’s chances for success on either the appeal or the writ are hard to judge. One legal source noted that on-point precedent in this area is sparse, but it may be that Amarin could only appeal a final ruling by ITC, not an administrative decision such as this. And as far as the Writ of Mandamus goes, the procedure is arcane enough that few lawyers with food and drug practices contacted by NutraIngredients-USA felt sufficiently familiar with the procedure to comment.
Bethany Kennedy, an attorney in the firm Emord and Associates, said filing such a writ does come up in conversation with her clients from time to time, but the idea is rarely if ever acted upon.
“It is a technical legal procedure. If you file a citizen’s petition with FDA and FDA sits around and doesn’t move on it, a client could consider this. Or if FDA has 180 days to act on something, and that deadline is passed, we sometimes tell clients they could file a writ. While that might be an option, only very rarely does it come up and clients usually decide for financial reasons not to go through with it,” she said.