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

Cross-posted on Stanford’s Law and the Biosciences Blog

As I have previously written about here, in January FDA published a controversial revision to its regulations defining “intended use,” and then, in the wake of procedural and substantive objections to the revised definition, the agency delayed the effective date of the new rule until March 2018.  These revisions are important because the “intended use” of a product is crucial for determining whether the product is a drug or device subject to FDA jurisdiction at all, and if so, whether the drug or device is in compliance with various FDA requirements.  Accordingly, there is significant interest in the kinds of evidence that FDA considers relevant to determining a product’s intended use.  The January revision to FDA’s regulations explained that that FDA would use a “totality of the evidence” approach to determining intended use, which would permit the agency to look to “any relevant source of evidence,” including, perhaps most controversially, a manufacturer’s knowledge about consumers’ and patients’ actual uses of the product.  The procedural “logical outgrowth” arguments against this standard do not persuade me for the reasons I explained here.   Likewise, I am not sure the substantive arguments against the revised regulations convince me.

One such substantive objection is that a “totality of the evidence” approach is a departure from what FDA has done in the past and is impermissible because FDA should limit its focus to manufacturers’ representations about their products (see, e.g.here and here). (This conflict between FDA’s more expansive view of what constitutes evidence of intended use and regulated industry’s more narrow view is nothing new, as Lewis Grossman has described in some of his work.)

Although, to my knowledge, FDA has not previously described its intended use determinations as based on a “totality of the evidence” standard in those precise words, it seems to me that relying only on manufacturer representations would be far too narrow of an approach.  After all, the statute talks about “intended” rather than, for example, “claimed” or “represented” uses.  Additionally FDA, arguably, does have a track record of taking a totality of the evidence approach, and certainly has some track record of relying on evidence beyond manufacturer representations in its intended use determinations.  Past examples include FDA’s efforts in the 1990s to regulate tobacco products as drug-device combination products, when the agency pointed to the inclusion of nicotine in the products as one piece of evidence that manufacturers intended them to affect the structure or function of the body, as well as several warning letters in which FDA pointed to a product’s design or ingredients as evidence that the products had drug or device intended uses.  And there is the (in)famous Travia case, in which Judge Thomas F. Hogan of the D.C. District court agreed with the government that unlabeled and unadvertised balloons of nitrous oxide, distributed outside a concert, were drugs because “the environment provided the necessary information between buyer and seller” and an intent that the product would affect the structure or function of the body could be surmised.

(A bit of random trivia about Travia: a brief google search suggests that the concert was a Dave Matthews Band concert. Having attended a possibly embarrassing number of such concerts in my middle and high school days, this tidbit makes me a little nostalgic.)

So, in short, perhaps the precise words that the agency used in its revisions to the intended use definition are new, but the approach that the agency outlines strikes me as consistent with what the agency has long done.  That is, I think the changes to the regulatory definition—rather than being genuine changes—are meant to be clarifications, and FDA is probably on strong legal footing to let the changes go into effect. For those interested, my co-authors, Micah Berman and Natalie Hemmerich, and I explore the kinds of evidence that the agency can consider to determine a product’s intended use in more detail in a forthcoming article on synthetic nicotine, posted here and discussed by Erika here.

But, of course, none of this means that these changes necessarily will go into effect.  There may be policy or practical forces that discourage the agency from moving forward—only time will tell.


Leave a Reply