Decoding FDA’s Statement on DIY Gene Therapies

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

In late November, FDA posted a statement on its website about the “self-administration of gene therapy”—which various media outlets interpreted as a reaction to some companies recently posting videos of consumers “self-experimenting” with gene therapy. One question that arose in some of the reporting—and in an exchange on twitter—is, what is FDA’s authority to regulate do-it-yourself (DIY) gene therapy?

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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.

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The Logical Outgrowth Doctrine and FDA’s Intended Use Revisions

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).

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NASEM Report on Pain Management and the Opioid Epidemic

Disclosure: I served as a consultant to the Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse.

Last year, FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to appoint a committee to study the role of opioids in pain management and the opioid epidemic, and, among other things, to provide the agency with recommendations on the options available to it to address the epidemic. Today that committee’s report was released.  As noted above, I served as a consultant to the committee—and I will let the report speak for itself. But there is a lot in the report that may be of interest to the FDA law and policy crowd, and I look forward to hearing reactions to the report and the recommendations included in it.

Advisory Committees and Industry-Funded Patient Advocacy

Cross-posted on Notice & Comment and Stanford’s Law and the Biosciences Blog.

Industry funding of patient advocacy organizations recently has received attention from media and researchers.  For example, one 2017 study in the New England Journal of Medicine found that over 80% of patient advocacy organizations with annual revenues of at least $7.5 million reported receiving industry funding; another study in JAMA Internal Medicine found that approximately 65% of patient advocacy organizations with a median annual revenue of about $300,000 reported receiving industry funding; and a post on the Hastings Center’s website (and an earlier JAMA Internal Medicine editorial) reported that one pharmaceutical company funded an advocacy organization that, in turn, recruited other patient advocacy groups to speak in favor of the company’s drug when FDA was considering approving it.  This last story highlights one area where the rubber meets the road with respect to FDA and patient advocates’ conflicts of interest: advisory committee meetings.

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I <3 Intended Use (and why some new technologies may fall within FDA jurisdiction)

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?

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FDA Highlights from the Health Law Profs Conference

Last week, the American Society of Law, Medicine & Ethics held its annual Health Law Professors conference—and my own institution, Georgia State University College of Law, had the pleasure of hosting the conference.

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The Intended Use Hullabaloo

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.

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Welcome to Objective Intent!

We are delighted to introduce Objective Intent, a blog in which we explore legal and policy issues associated with the U.S. Food and Drug Administration (FDA).  The FDA is an important and (we think) particularly interesting agency that has broad powers to achieve its public health mission and jurisdiction over roughly 25% of the consumer economy.  As some readers will know, the title of our blog, “Objective Intent,” comes from FDA regulations that define “intended use.” This title both pays homage to the critical role that a product’s intended use plays in many FDA controversies and reflects our hope that this blog will serve as a space for objective reflection on FDA issues by legal academics.