Thursday, January 28, 2016

Off-Label Marketing of DSHEA Products

Update: On March 9, 2016 FDA and Amarin reached a settlement of the issues:

"On March 8, Amarin filed a proposed Stipulation and Order of Settlement, resolving its constitutional and other claims. The proposed settlement requires FDA to be bound by the determinations in Amarin Pharma and, further, to “contact Amarin with specific concerns or objections [regarding] proposed communications about the off-label use of Vascepa that Amarin has not yet communicated to doctors in promotion . . . .”  Amarin, meanwhile, must “assur[e] that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.”*

Memorandum from Ralph Fucetola JD

To: Vitamin Consultancy Contact List:

I'd like to share this law note that I provided last month to my retainer clients.


Amarin Pharma vs FDA

Case 1:15-cv-03588-PAE
Injunction Issued 07 August 2015
United States District Court
Southern District of New York

"[T]ruthful and non-misleading commercial speech is constitutionally protected…"

Off-label pharmaceutical claims get First Amendment protection. What about structure & function or health claims for nutrients? Can FDA discriminate against nutrients because they are not FDA-approved, but rather grandfathered under DSHEA? Articles from the FDA Law Blog and from Nat Law Review explore the Amarin case. After reviewing the Injunction and several reports on it, I am of the opinion that “off label” use for Dietary Supplements cannot be prevented by FDA, so long as the claims are carefully presented as substantiated but not conclusive. That does not mean you can claim to “treat disease.” It does mean that social media chatter and consumer review marketing can now be a bit more adventurous…

The FDA Law Blog noted:

“In a bold move, Amarin filed a civil complaint against FDA claiming that FDA’s threat of prosecution for misbranding Vascepa had a chilling effect on Amarin’s commercial speech that was otherwise protected by the First Amendment.  For that reason, Amarin sought declaratory and injunctive relief that would prevent FDA from prosecuting the Company for truthful, non-misleading speech…”

Further, Nat Law Review noted:

"When FDA made it clear that it would consider such communications evidence of misbranding, Amarin brought suit alleging that the statements were truthful non-misleading speech, which the Second Circuit, in Caronia, had found could not form the basis of a misbranding action under the Food, Drug and Cosmetic Act (FDCA) because interpreting the act to prohibit this conduct would violate the First Amendment. Following a practice it had used in other cases, FDA sought to moot judicial review through use of a June 5, 2015 letter representing that it would not consider certain statements evidence of misbranding if Amarin abided by certain restrictions and conditions. FDA, however, declined to make any such representation with respect to the “supportive but not conclusive research” statement." 

And note especially the last sentence here:
"In a clearly worded rebuke of FDA’s efforts to limit Caronia to the facts of that case, the Court made clear that Caronia meant what it said: “the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.” Caronia, 703 F.3d at 168-69. The court found that the FDA’s June 5th letter had not mooted the case and controversy before the court, slip op. at 42, noting that Amarin had never agreed to – and was not required to agree to – FDA’s proposed restrictions limiting communications on the use at issue to, inter alia, communications initiated by doctors, communications in “scientific” settings and communications not made by sales staff, noting that the reasons given in Caronia “apply across the board to all truthful and non-misleading promotional speech.” Slip op. at 51." 

"It further rejected the complex “speech as evidence of intent” statutory rationale advanced by FDA for exempting regulation of off-label promotion from First Amendment scrutiny, observing that since “the FDCA’s drug approval framework predates modern First Amendment law respecting commercial speech …the provisions of a 1962 statute that implicate such speech, such as the FDA’s misbranding provisions, today must be considered, and to the extent ambiguous construed, in light of contemporary First Amendment law, under which truthful and non-misleading commercial speech is constitutionally protected, subject to the Central Hudson framework.” Slip op. at 49."

"Interestingly, the court specifically rejected FDA’s argument that a “substantial but not conclusive” claim that would be permissible under the standards applicable to dietary supplements would be sufficiently potentially misleading to ban in the context of drugs. In rejecting FDA’s argument that only communications supported by “significant scientific agreement” should be permitted with respect to prescription medications, the court discounted FDA’s suggestions that doctors are incapable of processing the significance of the distinction between these two measures of evidential support. Slip op. at 62-63."

See more at:

The Court noted:

“The Court has held that Amarin’s proposed communications, as modified herein, are presently truthful and non-misleading. But the dynamic nature of science and medicine is that knowledge is ever-advancing. A statement that is fair and balanced today may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired. The Court’s approval today of these communications is based on the present record. Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.”  [(Id. at 66.)]

Concluding, the FDA Law Blog suggested,

The court flatly rejected FDA’s interpretation of Caronia and stated that “[t]he [c]ourt’s considered and firm view is that, under Caronia, the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment.” 

Or, as the Supreme Court put it in Thompson v. Western States Medical Center, decided on April 29, 2002 - 535 U.S. 357, has offered significant support to Commercial Free Speech.

This decision has not received the attention of the marketplace that it deserves. The 5 to 4 majority decision revealed a Court deeply divided on the issue of Commercial Free Speech. One large minority of four justices, led by the Chief Justice, would have given the government far greater leeway to regulate Commercial Speech than the majority decision allows. The other large minority of four, led by Justice O'Connor, repeated the Two Prong Test of prior cases, applying it to FDA statutory requirements. The swing vote, Justice Thomas, is most telling. In his Concurring Opinion, the Justice refers to "Commercial Speech" only in quotes, indicating that he takes the position that there is no "Commercial" Speech, just Speech, protected by the First Amendment.

This case concerns a clause in the Food, Drug and Cosmetics Act that allows pharmacists to "compound" medications for specific prescriptions without safety testing and FDA prior approval, but forbids pharmacists from advertising the specific compounds they make. The Supreme Court held that the restriction on Commercial Speech was unconstitutional, using language that will help broaden not just the rights of pharmacists, but also the rights of all people in the health and wellness field, including those who sell nutrients. We might dub it the Public’s Right to Truth Decision. Some of the language used in Justice O'Connor's Majority Decision that sets the tone is as follows:

"If the First Amendment means anything, it means that regulating speech must be a last - not first - resort."

"We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information."

"Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each compounded drug to be labeled with a warning that the drug had not undergone FDA testing and that its risks were unknown."

The basic rule, announced by the case, to determine constitutionally permitted government restrictions on Commercial Speech (speech that makes or is about an offer for a transaction) is a Two Prong Test: the first prong is to ask two questions: (1) is the speech in question about unlawful activity and (2) is the speech misleading. If "no" to both, the speech is entitled to protection unless the Government can carry its burden and prove (1) the governmental interest involved is "substantial", (2) the regulation must "directly advance" the governmental interest and (3) the regulation of Commercial Speech cannot be "more extensive than is necessary to serve that interest" (quoting Central Hudson v Public Service, 447 US 557, at 566).

Commercial speech is speech, whether about an FDA approved drug or a nutrient lawfully sold under DSHEA.

December 15, 2015

* "Defendants agree to be bound by the Court' s conclusion that Amarin may engage in truthful and non-Inisleading speech promoting the off-label use of Vascepa@, i. e , to treat patients with persistently high triglycerides, and under Caronia, such speech may not form the basis of a prosecution for misbranding."