Continuing with FDA-related scholarship posted on SSRN in February and March: Professor Noah explores the possibility of “reverse switches” from over-the-counter (OTC) status back to prescription status (or perhaps, he suggests “behind the counter” status) in response to new safety information. Professor Paradise explains the provisions of the 21st Century Cures Act that contemplate greater patient involvement in medical product development, and Professors Evans and Ossorio evaluate the 21st Century Cures Act exclusion of clinical decision software from the agency’s medical device authority.
Here is what is new and interesting from the last two months. I’ll start with two articles on off-label promotion and two articles relating to tobacco regulation.
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.
Here’s what to read on SSRN, relating to FDA law, from September 2017. One piece contributes to a growing literature on the relationship between inter partes review and Hatch-Waxman litigation, and one piece dives into application of intended use doctrine to synthetic nicotine products.
Cross-Posted on Notice & Comment
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).
Cross-posted on Stanford’s Law and Biosciences Blog
A few news stories over the past week or so—one in the Wall Street Journal about “neurotech,” one in Geek Gadget about “neuroscience wearables,” one in the Washington Post about baby monitors for measuring an infant’s vital signs, and one in Gizmodo about “vaginal wellness products” marketed on Etsy—reminded me how much I enjoy questions of intended use. As I wrote last week, intended use is a critical concept in FDA law, in part because a product’s intended use is crucial to determining whether it meets the law’s definition of drug or device within the FDA’s jurisdiction. And, for whatever reason, I have an unabashed and—as far as I can tell—limitless love for thinking through questions about whether, and how, products fall with the definition of a drug or device.
As for the reported neurotech, neuro-wearable, baby monitor, and vaginal wellness products, it seems to me that many of these products may fall within the Federal Food, Drug, and Cosmetic Act’s (FDCA) definitions of drugs or devices. Why is that?
In the spirit of our blog’s title, this is the first of several posts to tackle the FDA’s controversial revisions to its regulations defining “intended use” and describing the evidence relevant to determining a product’s intended use. This post covers the background—what has happened, and why it is important. Subsequent posts will cover some of the substantive and procedural concerns that have been raised about the agency’s revisions.