December 5, 2023


Advocacy. Mediation. Success.

What to Make of Substantive Objections to FDA’s Intended Use Revisions?

By Patti Zettler, Affiliate Professor, Georgia State College University of Law and CLB Fellow alumna

Cross-posted on Goal Intent

As I have formerly created about here, in January Fda revealed a controversial revision to its restrictions defining “intended use,” and then, in the wake of procedural and substantive objections to the revised definition, the agency delayed the helpful date of the new rule until eventually March 2018.  These revisions are crucial mainly because the “intended use” of a item is crucial for determining no matter whether the item is a drug or machine subject to Fda jurisdiction at all, and if so, no matter whether the drug or machine is in compliance with numerous Fda specifications.  Appropriately, there is significant curiosity in the sorts of proof that Fda considers appropriate to determining a product’s intended use.  The January revision to FDA’s restrictions defined that that Fda would use a “totality of the evidence” tactic to determining intended use, which would permit the company to glance to “any appropriate resource of proof,” which include, perhaps most controversially, a manufacturer’s knowledge about consumers’ and patients’ actual works by using of the item.  The procedural “logical outgrowth” arguments in opposition to this common do not persuade me for the factors I explained here.   Similarly, I am not absolutely sure the substantive arguments in opposition to the revised restrictions influence me.

A single these types of substantive objection is that a “totality of the evidence” tactic is a departure from what Fda has finished in the earlier and is impermissible mainly because Fda ought to limit its aim to manufacturers’ representations about their solutions (see, e.g., here and here). (This conflict between FDA’s much more expansive watch of what constitutes proof of intended use and regulated industry’s much more slender watch is practically nothing new, as Lewis Grossman has described in some of his do the job.)

While, to my knowledge, Fda has not formerly described its intended use determinations as dependent on a “totality of the evidence” common in those specific phrases, it would seem to me that relying only on company representations would be considerably far too slender of an tactic.  Just after all, the statute talks about “intended” alternatively than, for instance, “claimed” or “represented” works by using.  In addition Fda, arguably, does have a observe history of using a totality of the proof tactic, and definitely has some observe history of relying on proof further than company representations in its intended use determinations.  Past examples consist of FDA’s initiatives in the nineteen nineties to regulate tobacco solutions as drug-machine blend solutions, when the company pointed to the inclusion of nicotine in the solutions as a person piece of proof that brands intended them to impact the composition or purpose of the physique, as very well as various warning letters in which Fda pointed to a product’s layout or substances as proof that the solutions had drug or machine intended works by using.  And there is the (in)famous Travia case, in which Choose Thomas F. Hogan of the D.C. District court agreed with the govt that unlabeled and unadvertised balloons of nitrous oxide, dispersed exterior a concert, were prescription drugs mainly because “the setting delivered the vital facts between purchaser and seller” and an intent that the item would impact the composition or purpose of the physique could be surmised.

(A bit of random trivia about Travia: a brief google search indicates that the concert was a Dave Matthews Band concert. Acquiring attended a perhaps uncomfortable range of these types of live shows in my middle and higher school days, this tidbit would make me a little nostalgic.)

So, in quick, perhaps the specific phrases that the company utilised in its revisions to the intended use definition are new, but the tactic that the company outlines strikes me as regular with what the company has extended finished.  That is, I believe the changes to the regulatory definition—rather than currently being genuine changes—are intended to be clarifications, and Fda is most likely on robust authorized footing to enable the changes go into outcome. For those interested, my co-authors, Micah Berman (like me, an SLS alum!) and Natalie Hemmerich, and I discover the sorts of proof that the company can take into account to figure out a product’s intended use in much more depth in a forthcoming article on synthetic nicotine, posted here and mentioned by Erika Lietzan on Goal Intent here.

But, of study course, none of this signifies that these changes necessarily will go into outcome.  There may perhaps be policy or functional forces that discourage the company from transferring forward—only time will inform.