DOJ lawyer: FDA guidance not forthcoming on legal dispute over fish oil supplements

At the crux of a court case on appeal in the nation’s capital are questions over the legality of certain synthetically produced omega-3 products being marketed as dietary supplements.

But the federal agency responsible for regulating drugs and dietary supplements doesn’t intend to issue any guidance specific to the dispute, a government lawyer disclosed this summer.

“You asked if there was guidance forthcoming from FDA on the specific question presented by the regulatory classification of these articles and the answer is no,” attorney Joseph Busa of the U.S. Department of Justice said June 8 during oral arguments before a federal appeals court in Washington. “FDA has not made a decision about whether these articles are unapproved new drugs or rather dietary supplements, and there is no guidance forthcoming on that specific question."

Busa mentioned FDA is working on final guidance related to new dietary ingredients, but he conceded it “wouldn’t specifically resolve the question presented about these articles and whether they are or are not dietary supplements within the meaning of the FDCA [Federal Food, Drug & Cosmetic Act].”

The issue before the U.S. court of appeals is whether it should send a case back to the U.S. International Trade Commission (ITC), ordering it to commence an investigation filed by wholly-owned subsidiaries of Amarin Corp. plc, a biopharmaceutical company that sells the drug Vascepa.

In 2017, ITC declined to open an investigation, prompting Amarin to file an appeal with the Federal Circuit.

Amarin had alleged certain products being marketed as supplements are unapproved new drugs. The false labeling of the products, the company asserted, constitutes an unfair act or method of competition under Section 337 of the Tariff Act of 1930 because the acts violate the Lanham Act and standards established by the FDCA.

Busa suggested the complaint filed with the ITC was an inappropriate attempt to enforce the FDCA, a task Congress assigned exclusively to FDA, and Amarin could ask FDA to examine whether the fish oil products are unapproved new drugs.

Amarin declined to comment whether it has sought administrative relief with FDA, and FDA did not respond to a request for comment.

“Is the FDA required to do an investigation on every case?” Chief Circuit Judge Sharon Prost asked the Justice Department lawyer.

Busa acknowledged FDA isn’t required to do so, alluding to the fact that FDA has limited resources.

“There are many things the FDA could be pursuing around the country,” the government lawyer said. “Is this the most important? That is a decision that Congress assigned to the FDA—the expert decision makers in this issue.”

He added, “Amarin would have you open that exclusivity up with the necessary consequence that there would be cases all around the country in district courts on Lanham Act claims that would force non-expert decision makers to make these very difficult judgments and divide the agency’s attention….”

That’s hardly Amarin’s perspective. Ashley Parrish, a King & Spalding LLP lawyer representing Amarin, argued ITC was required under the Tariff Act to initiate an investigation, and he said the appeals court had jurisdiction to hear the case.

“The commission can’t divest this court of jurisdiction by avoiding that mandatory obligation and then going on ahead and saying, ‘Well because we avoided that mandatory obligation now the court has no authority to review,’” he said. “Congress contemplated both that this court would have authority to review final decisions, and second that except in limited circumstances specified in the statute, that the commission would initiate an investigation and would not make these threshold judgments.”

ITC’s decision not to move forward with a probe, Parrish said, was based on a legal conclusion inconsistent with a decision by the U.S. Supreme Court, circumventing the agency’s statutory duty to commence an investigation.

He specifically mentioned POM Wonderful LLC v. Coca-Cola Co., a 2014 decision in which the Supreme Court rejected the notion that the FDCA and its regulations bar Lanham Act challenges to the name and label of Coca-Cola’s juice blend. Writing the decision, Justice Anthony Kennedy, who retired last month from the Supreme Court, described the Lanham Act and FDCA as “complementary.”

The case, Kennedy wrote, is not one “where a lawsuit is undermining an agency judgment, and in any event the FDA does not have authority to enforce the Lanham Act.”

Circuit Judge Even J. Wallach questioned Parrish about the applicability of Kennedy’s remarks to Amarin’s claim.

“Now, the claim here goes right to the heart of the FDCA as a central component of the complaint, right?” the judge asked.

Parrish said he disagreed with that assessment and was willing to explain, but the judge seemed skeptical.

“Your complaint is that the accused products are unapproved new drugs,” Wallach said. “It’s directly implicating FDCA, no?”

Parrish concurred the complaint directly implicates the FDCA.

But later in the exchange, he explained, “Our point, Your Honor, is that the Congress has allowed the commission [ITC] to look at the existing state of the law, the regulations and the statutes under the FDCA and any guidance by the FDA, and make a determination as to now whether or not under the Tariff Act that is harming the domestic industry and applying the standards under the Tariff Act.”

Houda Morad, a lawyer with ITC’s Office of General Counsel, suggested there are instances in which an agency like ITC could adjudicate a claim related to FDA issues. However, she said claims would be barred in cases “where the tribunal has to interpret or apply the FDCA in the first instance.”

The lawyer cited instances in which ITC commenced “investigations when the issue turned on FDA approval status.”

“Whether something is FDA approved or not doesn’t require interpretation of the FDCA,” she said.

 In one colorful exchange over language in the Tariff Act, Prost jousted with Mark Davies of the law firm Orrick, Herrington & Sutcliffe LLC. Davies appeared on behalf of DSM Nutritional Products LLC, Pharmavite LLC and others named in Amarin’s original complaint.

“Let me move to the statutory construction issue of ‘shall investigate,’” Prost said, quoting language in the Tariff Act that states, “The Commission [ITC] shall investigate any alleged violation of this section on complaint under oath or upon its initiative.”

“Why isn’t that as clear as it gets in terms of compelling the ITC to initiate an investigation in every complaint?” the judge asked Davies.

“If the statute just said ‘shall,’ then … that would be much harder for us but there’s a key word, which is ‘upon its initiative,’” the lawyer responded. “The same word ‘shall’ modifies both ‘on complaint’ and ‘upon its initiative.’”

Prost wasn’t persuaded.

“I’m sorry. I for one don’t buy that. ‘On its own initiative’ is talking about something else,” Prost shot back. ‘Shall’—my read of that section—is, ‘shall initiate an investigation based on a complaint’ … or ‘on its own initiative.’ I think the only way … to have any clarity in that statement is to divide the two up, right?”

Davies held his ground.

“With respect, Your Honor, no because … if you put the period in, then you have half a sentence,” the lawyer responded.

Later in the exchange, he referenced legislative history suggesting Congress used the word “shall” as “may” rather than “must.”

“Well you can tell the Supreme Court that ‘shall’ means ‘may’ or not ‘must,’ but I’m a little scared to try to do that,” Prost replied.

Judge Todd M. Hughes seemed concerned Amarin would have nowhere to turn for relief if the court found it lacked jurisdiction to hear the case.

“I’m sure you well know that there’s a strong presumption of judicial review and to overcome that, Congress has to speak very explicitly,” he said, addressing Davies. “And I don’t think we see anything in the statute that suggests judicial review of this question is barred altogether. It may not be that we’re the right forum, but there must be some forum to contest the ITC’s assertion that it lacks authority.”

He asked whether, for example, the case was actionable under the Administrative Procedure Act (APA) based on ITC’s failure to properly use its authority.

“This can’t be the type of unreviewable agency action that is precluded … either in this statute or in the APA,” the judge said. “It just doesn’t … seem to me like that is altogether unreviewable.”

Davies responded that “the APA, of course, plays an important role in guiding agency action, and so if they had an argument,” Amarin could make it.

“So, I don’t want to be coming across as suggesting otherwise,” he added. “I did have one final point, Your Honor.”

But the judge cut him off.

“You do see our problem here that … if we proclaim that we lack jurisdiction, I would think that we’d want to at least be assured somewhat that there’s jurisdiction somewhere,” Hughes said, “because I don’t think we want to imply that this is an unreviewable question.”