Amarin Decision Could Spur Pressure Against FDA On Supplement Claim Policy

First Amendment advocate Jonathan Emord says the industry bows to FDA “intimidation” in not making truthful claims for their products. But the federal district court ruling for Amarin is the latest decision to strike against FDA’s policy on regulating supplement label claims, he says.

A recent court decision allowing marketing statements about an unapproved use of an Rx omega-3 fish oil drug likely will spur dietary supplement firms to gradually challenge rather than rush to contest FDA’s regulation of health claims for their products.

Attorney Jonathan Emord, a staunch First Amendment advocate who has represented clients in pivotal litigation about supplement health claims, sees the federal district court ruling for Amarin Corp. PLC as the latest decision to strike against FDA’s policy on regulating supplement label claims.

However, Emord says even though court decisions in Amarin and similar disputes reject FDA’s regulatory policy that prohibits making certain truthful and scientifically substantiated claims about regulated products, supplement firms likely will not rush to test the agency with new or stronger health claims.

“There’s a tremendous intimidation factor. FDA overreaches and so the effect is to cause self-censorship. Parties are more apt to refrain from communicating information that is protected by the First Amendment simply because of fear the FDA will act against them,” Emord, whose practice, Emord & Associates Inc., is based in Clifton, Va., said in an interview.

“I don’t anticipate there will be an opening of the floodgates, nor do I anticipate that there will be numerous health claims petitions filed in response to this, but I do think over time this case will cause an increase in the amount of information communicated to the public.”

In an Aug. 7 decision, Judge Paul Engelmayer of US District Court for the Southern District of New York said Amarin may engage in truthful and non-misleading speech about the unapproved use of Vascepa (icosapent – a purified ethyl ester of eicosapentaenoic omega-3 fatty acid) in patients with persistently high triglycerides despite the use of statin therapy, and that such speech may not form the basis of a misbranding lawsuit (Also see "Amarin's First Amendment Victory Could Cut Both Ways For Industry" - Pink Sheet, 17 Aug, 2015.).

Judge Engelmayer also endorsed a package of statements, materials and disclosures for Amarin's use in its communications with health care providers and ruled that First Amendment protection for truthful and non-misleading speech about off-label uses extends to sales representatives' conversations with physicians.

FDA countered Amarin’s argument that regulation of its communications violates its First Amendment right to free speech by contending that the agency is authorized to look at the firm’s dissemination of information about unapproved uses “as evidence that Amarin intends a new use” for Vascepa (Also see "First Amendment Suit: FDA Draws Line At Amarin's Heart Disease Claim" - Pink Sheet, 29 Jun, 2015.).

Relevant To Supplement Claims?

Emord said drugs should not be the only products affected by the Amarin decision and by the 2012 federal appellate court ruling in US v Caronia, which said the government cannot prosecute manufacturers or their representatives for speech promoting the lawful, off-label use of an FDA-approved drug.

He does not expect FDA, however, to change without a push from the supplement industry.

“Sooner and sooner or later there will be litigation that expands into areas outside of this prescription drug context into foods and dietary supplements,” he said.

Food and supplement law attorney Justin Prochnow also expects no change in FDA enforcement on supplement claims, but he says congressional intervention, rather than litigation would be needed to change how the agency regulates claims allowed for dietary supplement ingredients.

The regulatory framework established by the Dietary Supplement Health and Education Act prohibits making a disease claim for a dietary supplement and, no matter how strong the supporting science, FDA will not allow a claim that a dietary ingredient prevents, treats, cures or mitigates a disease condition, said Prochnow, of Greenberg Traurig LLP in Denver.

“It’s not an issue of whether there’s science to support it, it’s simply that the law says a dietary supplement cannot make a disease claim. Congress has simply said, ‘you can’t sell it to treat a disease,’” he said in an interview.

“Parties are more apt to refrain from communicating information that is protected by the First Amendment simply because of fear the FDA will act against them.” – attorney Jonathan Emord

Prochnow said he expects FDA, as it did in the Caronia litigation, will appeal the Amarin decision. Any challenge to the agency’s supplement claim regulation stemming from Amarin likely would not come until after an appellate decision.

“You’re still taking a pretty big risk before this case goes through the circuit and a circuit court decision has been made and maybe eventually the Supreme Court will hear the case,” he said.

‘Offend The First Amendment’?

FDA regulations will allow supplements to bear health claims that associate a product with reduced risk of disease, but the approval bar is high as the process requires an extensive review of scientific literature and typically the submission of a citizen petition before authorization.

The Global Organization for EPA and DHA Omega-3 has submitted a citizen petition asking FDA to allow unqualified blood pressure and coronary heart disease risk reduction health claims for omega-3 supplements, submitting a petition based on a meta-analysis of 70 studies finding overall that EPA and DHA statistically reduced systolic and diastolic blood pressure (Also see "Omega-3 Petition Seeks Unqualified Blood Pressure, CHD Claims" - Pink Sheet, 3 Feb, 2014.).

FDA On QHCs

Since 2003, FDA has allowed conventional foods and supplements containing omega-3 fatty acids – eicosapentaenoic and docosahexaenoic – to bear the qualified heart disease claim: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [product name] provides [number of grams] of EPA and DHA omega-3 fatty acids.”

QHCs signify “emerging evidence” for a relationship with reduced risk of disease or health condition, but “the evidence is not well enough established to meet the significant scientific agreement standard required by FDA to issue an authorizing regulation,” according to the agency.

In addition to the omega-3, the QHCs FDA allows for ingredients commonly used in supplements include:

• “Some evidence suggests that calcium supplements may reduce the risk of colon/rectal cancer.”
• “Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer.”
• “Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer.”
• “As part of a well-balanced diet that is low in saturated fat and cholesterol, Folic Acid, vitamin B6 and vitamin B12 may reduce the risk of vascular disease.”

Emord said the Amarin ruling should shake up FDA’s qualified health claims policy and push the agency into fully complying with the Supreme Court’s decision in Pearson v. Shalala, the 1999 case that he argued for the plaintiffs and that led to agency adopting its QHC policy (Also see "Selenium Claim Ruling Forces FDA's Hand, May Clear Path For More QHCs" - Pink Sheet, 7 Jun, 2010.).

“There are many problems with FDA’s system that offend the First Amendment,” he said.

Noting that FDA rejects claims that dietary ingredients can treat a disease or condition despite research showing efficacy for some, he said the QHC system “eschews any evidence except that which [FDA] deems to be direct proof of preventive effect or risk-reducing effect.”

“So the FDA’s categorical rejection of that information and categorical rejection of say, animal studies, is unscientific and is biased in order to limit the amount of scientific information that’s truthful reaching the public.”

Prochnow points out, though, that in addition to the DSHEA prohibition on disease claims by supplement products, restrictions on commercial speech could sway courts to agree with FDA.

“It’s always good when a company wins on a First Amendment application argument,” he said, but added, “The First Amendment doesn’t apply to commercial speech in the same way it does to everyday speech.”

Although the Amarin decision involves an omega-3 ingredient, claims for other ingredients could be first to spark litigation against FDA’s supplement health claim policy, Emord added. “There are many possibilities out there and I suspect they will be exploited over time.”

“FDA is not at liberty as a constitutional matter to limit the First Amendment decision in Amarin to prescription drugs. It should apply across the board. In other words, FDA should be disarmed completely of any power whatsoever to restrict, burden or deny the right to communicate truthful information about any government-regulated product,” Emord said.

Judge Engelmayer directed Amarin and the government to confer by Aug. 24 on next steps in the case and to submit a joint letter stating their views by Aug. 28. FDA has 60 days in which to appeal; however, an appeal would go to the Second Circuit US Court of Appeals, the same court in which FDA lost the Caronia case.

Emord does not like the agency’s chances in appealing rulings that swing on the First Amendment rights of firms marketing regulated products, and he’s not impressed with FDA’s responses to those rulings.

“FDA thinks itself above the law and believes they can ignore decisions like this Amarin decision and proceed with its administrative processes regardless of what the court holds. But it’s tempting fate and sooner or later it might even experience a serious rebuke,” he said.

“The First Amendment is the supreme law. It trumps statute, it trumps regulation – it trumps anything that’s beneath it.”