Dear Colleagues --
Below is Amarin's response to FDA's brief to the commission that supports the industry's position. As the stakes ratchet up, we will look for a decision in about a week's time and will inform you promptly of that news, whatever it is.
Fair Trade Is Not FDA's Expertise, Amarin Says In Omega-3 Ingredients Filing
Executive SummaryMaker of Rx Vascepa says it's not asking trade panel to interpret the FD&C Act, but to investigate whether some omega-3 ingredient suppliers and marketers are failing to fulfill "certain marketplace expectations about the nature" of their products. ITC is about to decide whether to investigate complaint, which could impact a number of dietary supplement firms.
Amarin Corp. PLC says no federal law precludes the International Trade Commission from investigating fair trade complaints about FDA-regulated products, rebutting the agency's argument that ITC should reject the firm's complaint targeting a large swath of the omega-3 dietary supplement market.
The pharmaceutical firm marketing the Rx drug Vascepa, formulated with synthetic and concentrated omega-3 ingredients, released its response to FDA's brief one week before the commission is scheduled to vote on whether to initiate an investigation of Amarin's complaint. The commission recently moved its vote on Amarin's request to Oct. 27.
Amarin's response to FDA's brief emphasizes its view that the commission has authority to investigate complaints about advertising and marketing for products that the Food, Drug and Cosmetic Act authorizes FDA to regulate. It also reiterates the claims that formed the basis of its original filing with ITC: that the types of omega-3 ingredients Amarin targets are non-compliant with agency regulations. Some omega-3 ingredients used in dietary supplements available in the US are drugs, not dietary ingredients, the complaint alleges.
The company's response was prepared by the law firm King & Spalding LLP in Washington. Describing Amarin's request as "straight-forward," the attorneys led by Jeffrey Telep state that the complaint does not ask ITC to interpret the FD&C Act, but to investigate whether some omega-3 ingredient suppliers and marketers are failing to fulfill "certain marketplace expectations about the nature" of their products the act requires.
AMARIN'S COMPLAINT TARGETS PROTECTING THE MARKET FOR VASCEPA (ICOSAPENT ETHYL), A SYNTHETICALLY PRODUCED ETHYL ESTER APPROVED TO REDUCE TRIGLYCERIDE LEVELS IN ADULTS WITH SEVERE HYPERTRIGLYCERIDEMIA.
"All of the players in the chain of distribution of the synthetically produced omega-3 products at issue here rely upon those expectations, including the distributors selling the products to pharmacies and physicians, the pharmacies and physicians themselves, and consumers. When those players are misled, they are harmed, as are companies that sell competing products lawfully," Telep and his associates state.
Amarin contends in its complaint filed on Aug. 30 with the ITC, a division of the US Department of Commerce, that dietary supplements containing purified eicosapentaenoic acid (EPA) or omega-3 formulations containing primarily EPA in ethyl ester or re-esterified form are actually drugs, and asks the commission to block import of those ingredients by a number of companies. (Also see "Amarin's Omega-3 Fair Trade Complaint Questions US Dietary Ingredient Standards" - Pink Sheet, 7 Sep, 2017.)
The Dublin-based firm, seeking to protect the market for Vascepa (icosapent ethyl), a synthetically produced ethyl ester approved to reduce triglyceride levels in adults with severe hypertriglyceridemia, asserts that before these types of omega-3 fish oils were used as dietary ingredients they were the subject of investigational new drug programs, precluding their use as dietary ingredients under the Dietary Supplement Health and Education Act.
3 STRIKES AGAINST FDA'S REQUESTSaying it is "asking the Commission to call balls and strikes based on definitions" in the FD&C Act and previous FDA interpretations, Amarin divides its argument against FDA's request into three reasons:
It requests an order halting imports by 18 companies it identified as "Proposed Respondents" and that sell synthetically produced omega-3 oil as dietary supplement ingredients or as finished products with encapsulated synthetically produced omega-3 oil with purified EPA or omega-3 fatty acid mixtures that are predominantly EPA in ethyl ester or re-esterified form.
Supplement industry stakeholders argue that the omega-3 types Amarin is challenging were in the food supply long before they were IND candidates in the 1980s and that the firm is attempting to block US consumers' access to products entirely compliant with FDA regulations. The Council for Responsible Nutrition submitted a letter to ITC saying in part that Amarin's argument for its false advertising claim has been made in other litigation and repeatedly has been dismissed. (Also see "Amarin Makes Flawed Argument In Bid To Drain Omega-3 Market – CRN" - Pink Sheet, 15 Sep, 2017.)
FDA Asserts AuthorityIn an Oct. 6 letter to ITC, FDA Chief Counsel Rebecca Wood said Amarin's claims of violations of US trade and advertising laws as well as FDA regulations "all depend on the allegation that the products at issue" are falsely labeled as dietary supplements because the omega-3 ingredients should be regulated as drugs. (Also see "FDA Objects To Amarin Trade Complaint Against Omega-3 Ingredients" - Pink Sheet, 11 Oct, 2017.)
FDA also posits that much of what Amarin is requesting from ITC falls under the agency's oversight and would require expertise that the commission does not have.
In the latest letter to ITC, Amarin's attorneys say that under US trade regulations, "importers who engage in unfair trade practices that injure a domestic industry" are subject to complaints filed with the commission, "and nothing in the FDCA specifically limits those types of claims."
"Amarin should not be precluded from bringing a case, like this, that challenges Proposed Respondents for engaging in unfair trade practices – even if the challenge requires the Commission to look to certain provisions in the FDCA in conjunction with case-specific facts," the attorneys state.
Regulatory Conflicts No Impediment FDA also stated in its letter to ITC that a ruling for the firm following an investigation could conflict not only with finalized FDA policies, but also with rulemakings, guidances and other documents currently in development, including guidances on new dietary ingredient (NDI) notifications and on determining whether an ingredient is an NDI.
Congress didn't restrict ITC from investigating fair trade complaints and potentially rendering decisions that could conflict with other federal agencies' regulations, Amarin's attorneys say.
The firm's "question for the Commission is not whether FDA (or some other agency) might at some point seek to change regulatory requirements or expectations in a way that might have some bearing on whether the products at issue in this case are lawfully marketed as 'dietary supplements' under" trade and ITC regulations, according to the letter.
"Instead, the question is whether the statements being made today are false or misleading in a manner that is causing competitive harm."
Ceding authority to FDA on Amarin's complaint, the attorneys added, could set a precedent harmful to "competitive interests of countless" businesses and the public. "If the Commission were to abdicate its jurisdiction in this matter, and in all matters affecting FDA-regulated products … then it would not only subvert Congress's objectives… but also effectively provide a shield for wrong-doing."
ITC initially had extended its consideration of whether to investigate the firm's complaint through Oct. 20 before saying decision would take another week. If the commission initiates an investigation it will assign the case to an administrative law judge, who will set a target date for completion of the investigation.