What follows is our in-house source's thoughts on the recent Amarin First Amendment victory over the FDA.
We are witnessing a strange chapter in the hegemony of FDA control over drug promotion. For while the OIG and DOJ continue to make good use of their Swiss army knife of an Anti-Kickback Statute, the FDA has been taking body blows from First Amendment litigators. First, the Supreme Court’s Sorrell decision, Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), protecting promotional communications as commercial speech; next, the Second Circuit in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), vacating a misbranding conviction on First Amendment grounds; and finally, the Southern District of New York in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015), declaring that a manufacturer may legally engage in off-label promotional communications.
Any doubts that this may indeed be a watershed event should be assuaged by the FDA’s public relations campaign to marginalize Caronia and the agency’s anxious efforts to moot the Amarin case or controversy before decision.
After all, the attack here is not a flanking maneuver. It is aimed straight at the FDA’s weakened center and threatens to scatter the spoils of decades of doctrinal toil spent erecting the divide between on- and off-label communications, an article of faith in the industry. And, to add insult to injury, and in marked contrast to the restraint shown in Caronia, the opinion in Amarin deliberately sabotages a key justification for FDA’s land grab on this subject − that the FDA must be allowed to regulate truthful, non-misleading speech to protect the integrity of the drug approval process – by reasoning that the regulatory scheme “predates modern First Amendment law respecting commercial speech” and is thus vulnerable to “frontal assault” from manufacturers. 2015 WL 4720039, at *25.
Of course the victory is not conquest, and needs to be tempered by the acknowledgement that Caronia and Amarin reflect Second Circuit jurisprudence with limited precedential value outside of New York, Connecticut and Vermont. The decision is also not a blanket license to promote off-label. Different facts, and in particular different safety risks or less reliable scientific evidence, may result in a different balancing and warrant greater restrictions to protect the public health. And there is the court’s admonition that the First Amendment protects speech, not conduct, 2015 WL 4720039, at *27, so promotional tactics designed to increase off-label use may still receive the full treatment from OIG and DOJ. That being said, manufacturers are ahead of the FDA 3-0 in cases where the federal courts have applied Central Hudson’s commercial speech balancing test (see Central Hudson Gas & Electric Corp. v. Public Service Communication, 447 U.S. 557 (1980)). to drug promotion (4-0 if you include the venerable Washington Legal Foundation decision, WLF v. Friedman, 13 F. Supp.2d 51 (D.D.C. 1998)).
Given these caveats, the end game that will emerge from whatever chaos attends the demise of the FDA’s position is difficult to handicap at this point in time, which calls to mind Littlefinger’s apt observation, “Chaos is not a pit. Chaos is a ladder.” Interested observers, and forward thinking advisors, might be well-advised to climb that ladder and consider what this new world order would look like if this view from Manhattan were fully realized, at least for the sake of discussion. For one thing, the heretofore binary world, divided between scientific exchange (unregulated) and promotion (heavily regulated), turns into a tripartite world, with a third category one could label “protected speech”:
So while the distinction in 21 C.F.R. § 312.7, cordoning off communications that are made outside of “a promotional context,” still applies to emancipate scientific exchange, promotional speech would now be separated into communications subject to traditional FDA controls and a new category of truthful and non-misleading promotion that is neither necessarily on-label nor based upon “substantial evidence.” In effect, the dichotomy between on- and off-label communications disappears, since none of these three categories relies on the distinction as a criterion.
Most importantly, the authority for what is “truthful and not misleading” is not inevitably the FDA − which, if asked, is likely to take the position that the standard is coterminous with the existing substantial evidence requirements. Put another way, the Second Circuit decisions stand for the proposition that “truthful and not misleading” data does not need to meet the FDA’s heightened standard, or require FDA approval, before it can be communicated to healthcare providers.
This change, should it take hold, would be significant, but probably not as momentous as the hysterics among us would have you think. For one thing, one would expect that the drill for updating safety information would remain unchanged, since the interests of industry and the FDA are closely aligned on this issue. There is every incentive for manufacturers to continue to work through the existing FDA processes to bring about label revisions to ensure that accurate and up-to-date contraindications, adverse reactions and interactions are reflected in the label (and failure to warn defenses in product liability cases preserved). There is also much that remains on the FDA’s plate in terms of policing efficacy claims, even if the new standard is changed to truthful and not misleading. If anything, the change should presage more, rather than less work for FDA staffers, now stripped of the thick armor provided by a blanket off-label prohibition.
Would this be a good thing for patient health? It is hard to see how it would not be. Manufacturers have always been the best source for detailed scientific information about their products and have clamored for many years against seemingly arbitrary restrictions on their ability to communicate this information. Earlier efforts to fix the problem have fallen victim to what appeared to be kneejerk conservatism from the FDA – a condition that got the agency into this battle in the first place.