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 no 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 the safety information for the latter no longer applies is a question that has never been taken up formally by FDA.
Writ of Mandamus
Amarin appealed ITC’s decision in early December of last year. The appeal takes the form of something called a Writ of Mandamus, which essentially means the filer is trying to force a public official or agency to do something that it really ought to do.
The DOJ brief filed yesterday was done so on behalf of FDA. The brief’s main argument is that there is no right of private enforcement within the Food Drug and Cosmetic Act, which is what Amarin’s case before ITC amounts to. If Amarin wants a ruling on the legality of high concentrate forms of EPA (the chemical description of Amarin’s drug Vascepa), it was barking up the wrong tree, the brief in essence said. The DOJ brief says ITC was right when it said FDA, and FDA alone, has the jurisdiction to enforce FDCA.
“The FDCA instead commits enforcement exclusively to the federal government to ensure that complex enforcement decisions are made with the benefit of FDA’s scientific and regulatory expertise. As a consequence, private parties, like Amarin, may not initiate proceedings in a court or administrative agency to remedy alleged violations of the FDCA. Nor can private parties circumvent that prohibition by wrapping their FDCA enforcement claims inside some other cause of action. Private parties, like Amarin, may not initiate proceedings in a court or administrative agency to remedy alleged violations of the FDCA. Nor can private parties circumvent that prohibition by wrapping their FDCA enforcement claims inside some other cause of action,” the brief stated. (Emphasis in original text.)
Attorney Marc Ullman, of counsel with the firm Rivkin Radler, said the DOJ move was not unexpected.
“It’s not surprising that the US government is taking this position. The government is saying that these are questions for FDA and the filing with ITC was an attempt to circumvent the longstanding proposition that the enforcement of the FDCA rests solely with the agency,” Ullman told NutraIngredients-USA.
Underlying issues unresolved
Ullman said Amarin’s strategy in the case, while creative, seems ultimately headed for failure. But he said some of the underlying issues in the case are unresolved and are likely to crop up again. Some of the bones of contention embodied within the draft guidance on New Dietary Ingredients could provide leverage for other plaintiffs in future actions. Other ingredients could be attacked on the basis that they are on the market with only the haziest of regulatory underpinnings.
“Here we are, more than 23 years after DSHEA, and we still have no substantive guidance on these questions. For example, when FDA says ‘present in the food supply’ (one of the qualifications for proving Old Dietary Ingredient status), what does that mean? Present for a week? A month? And are ten units enough, or do you need 10,000?” he said.