Cross-Posted on Objective Intent

In January FDA published a controversial revision to its regulations defining a product’s “intended use” that, among other things, has raised an interesting logical outgrowth question. “Intended use” is an important concept in FDA law because a product’s intended use—judged by the “objective intent of the persons legally responsible for the [product’s] labeling”—can be crucial to determining whether a product is a drug or device subject to FDA oversight at all, and whether an FDA-authorized drug or device is in compliance with FDA requirements. (Readers can find more about “intended use” generally, and the background behind the current controversy, here). Because “intended use” is so important in the FDA world, it should come as no surprise that stakeholders that disagree with the revised definition in the January final rule—which has yet to go into effect—have lodged both procedural and substantive arguments against the revision (see, e.g., here and here).

One of the procedural arguments is that the revisions are not a “logical outgrowth” of the proposed rule. The APA requires that agencies engaged in rulemaking give the public adequate notice of the substance of a new rule to provide a meaningful opportunity to comment on agencies’ plans. The final rule need not be identical to the proposed rule to satisfy this notice requirement—which makes sense, otherwise why allow for public comment if agencies cannot change course at all. Instead, courts have said that the final rule must be a “logical outgrowth” of the proposed rule to satisfy the notice requirement.

What is interesting about the logical outgrowth argument against the FDA’s revised definition of intended use is that the definition of intended use provided in the January final rule seems closer to the definition of intended use that is currently in effect in FDA’s regulations than the definition in the proposed rule would have been.

Specifically, the current regulations (21 CFR §§ 201.128, 801.4) say that, to determine the intended use of a drug or device, the FDA may look to various forms of evidence including “labeling claims, advertising matter, or oral or written statements by [the persons legally responsible for the product’s labeling] or their representatives,” “circumstances surrounding distribution,” and most controversial, a manufacturer’s knowledge that its product will be used for purposes other than the ones the manufacturer offers the product for. This language about a manufacturer’s knowledge has long caused concern among medical product manufacturers because it suggests that if a manufacturer happens to be aware that health care providers prescribe or administer its products for off-label uses, the manufacturer may run afoul of the FDA’s policies on off-label promotion. In a move welcomed by industry, in 2015 FDA proposed to revise these definitions of intended use by, among other things, removing the language about a manufacturer’s knowledge. But in the final rule published in January 2017 FDA explained that its intent in the proposed rule was not to suggest that a manufacturer’s knowledge that a product is used in for a particular purpose could never be evidence that the manufacturer intends the product to be used for that purpose. Rather, the agency simply intended to clarify its longstanding position that a manufacturer’s knowledge that a product is used in a particular way, alone, rarely would be sufficient to establish that the manufacturer intended the product to be used that way. Thus, instead of completely removing the language about a manufacturer’s knowledge, the final rule says that FDA will use a “totality of the evidence” approach to determining a product’s intended use—meaning the agency may look to any source of evidence to determine intended use, including a manufacturer’s knowledge of a particular use. In this way, the January 2017 final rule, arguably, departs from the proposed rule by moving closer to the existing regulatory language.

So, does a final rule revising an existing regulation present a logical outgrowth problem if it (arguably) departs significantly from the proposed rule but does so by sticking closer to the existing regulation than the proposed rule would have? Practically, it seems to me the answer should be “no.” It is difficult to see how the public lacks adequate notice that an agency may include something in its final rule that is already in place. In other words, that an agency might revise a proposed rule to be closer to its existing requirements seems like something that is reasonably foreseeable—and, of course, the agency could simply never finalize a proposed rule, leaving the existing regulation in place. Indeed, in one case with somewhat similar facts, the Supreme Court explained that a proposed rule “was simply a proposal, its presence meant that the [agency] was considering the matter; after that consideration the [agency] might choose to adopt the proposal or to withdraw it.”  Relatedly, I wonder what a successful logical outgrowth challenge would achieve in this context. If the notice that FDA gave was inadequate, the result would be that the existing regulation—with the objected-to language permitting the agency to consider a manufacturer’s knowledge—would stay in place, at least until further revisions.   But I am curious to know what others think, and very curious to see what happens after the comment period on the final rule (extended through today) ends.