The communication comes on the heels of Amarin’s request last month to ITC to hear a case in which it alleges that certain 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 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).
Amarin, which was founded in New Jersey, 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.
FDA: This is our turf
In the letter, which was dated Oct. 6, FDA asked ITC to set aside the case because it 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.’
“As pled, Complainants’ claims—unfair methods of competition under the Tariff Act based on false advertising under the Lanham Act and violations of the Federal Food Drug and Cosmetic Act (‘FDCA’)—can succeed only if the Commission finds that Respondents’ products are unapproved ‘new drugs’ rather than ‘dietary supplements’ under FDCA. The Complaint here is predicated on open questions of law and policy on which FDA has not reached final conclusions. Any such findings by the Commission on those issues may conflict with later findings by FDA,” the letter stated.
FTC also reasoned that Amarin was de facto seeking private enforcement of the FDCA, a law for which no private right of enforcement exists. This is unlike some other regulations that affect the dietary supplement industry such as California’s Prop 65.
Industry welcomes move
Industry groups, such as the Global Organization of EPA and DHA Omega-3s (GOED), and the Council for Responsible Nutrition (CRN) applauded the move by FDA.
“We were concerned enough about this that we did reach out to FDA a couple of weeks ago to express our concern that this would diminish FDA’s exclusive jurisdiction of this sector,” Steve Mister, CRN’s president and executive director, told NutraIngredients-USA. “We have also had numerous discussions with our allies on Capitol Hill about this issue.”
Mister said he couldn’t comment on whether is was an unusual move for FDA to ask another agency to back off it its turf. But he did say that CRN was “Very pleased to see FDA take this action and we continue to monitor the case closely.”
On the first argument, the status of these forms of fish oils, Mister said he wishes FDA had been willing to make a more affirmative statement, other than it has “not determined whether the challenged products are drugs or dietary supplements.”
“When they said they have not made a public pronouncement about esterified fish oils, I wish they would have gone farther and said yes, they are dietary supplements. I think FDA is well aware that esterified fish oils have been in the marketplace since the 1980s,” he said.
Dangerous private enforcement precedent
As for the other issue, the right (or not) of private enforcement, Mister said FDA was quite rightly protecting its jurisdiction. These questions of what is an Old Dietary Ingredient and what could be properly identified as an NDI are thorny enough without judges jumping into the fray.
“The second argument is I think a more interesting one in that the FDCA does not create a right of private enforcement. However creative you might get with things like bootstrapping the Lanham Act onto it, to allow that would be to let judges to interpret that statute, which is something that only FDA should do,” he said.
Mister said he believes FDA is concerned about the precedent that the case could set for drug companies who subsequently come into the market to brush aside competition from dietary supplements. The sector’s overarching regulation—DSHEA—spells this out pretty clearly, he said.
“I think DSHEA absolutely envisions that there would be some situations along the way where the two could coexist. You would have some products making structure function claims for healthy people and other products that have been investigated as drugs to treat a specific condition making disease claims,” he said.
“If there is a supplement on the market first the drug company comes to that market knowing what they are getting into. If the drug is on the market first and has been investigated via clinical trials then you can’t also have a supplement,” he said.