This is the second in a series of posts on food and drug law scholarship posted to SSRN from January to June 2026. The 1980s were my decade, and as I read these three pieces, the lyrics to Once in a Lifetime started — and then would not stop — in my head. They consider … where we find ourselves.
You may ask yourself, “Where does that highway go to?”
And you may ask yourself, “Am I right, am I wrong?”
And you may say to yourself, “My God, what have I done?”
(Same as it ever was? Maybe a little bit. See below.)
Honey, I Shrunk the Agency. With reductions in force, voluntary departures, not-so-voluntary departures, FDA’s workforce has shrunk considerably — though its statutory obligations, which were never adequately funded, remain the same. With departures comes the loss of both expertise and institutional memory. Professor Horvath and Professor Sachs introduce their respective articles quoting Commissioner Califf’s remarks on his LinkedIn page: “The FDA as we’ve known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed.”
But their papers are different in a fun way. One takes up medical device regulation, notes that the main development of the last year has been a reduction in CDRH staffing, and then describes bold reform. The other takes up drug regulation, pointing to profound developments at CDER and CBER in the last year, anticipates the possibility of even more significant change, and then offers only modest proposals in the event we find ourselves in a “post-FDA world.”
George Horvath’s Medical Device Regulation: We Can’t Just Go Back (Nor Should We), in the Utah Law Review, takes the present moment as another opportunity to consider device reform.
So far, Professor Horvath notes, CDRH’s premarket work with medical devices has remained “largely stable overall.” To be sure, its post-market work, which is not supported by user fees, may suffer from the current staffing shortages. Staffing and resource shortages at CDRH are “not new,” though. Even before the current Administration, “device regulation had serious problems.” So although he situates this article in the present moment, Part III describes longstanding criticisms of FDA’s medical device framework — such as the “technology creep” that occurs with daisy-chained premarket clearances (colorfully described by John Oliver) (caution: quite crude), the fact that recalled devices sometimes serve as predicates for premarket notifications, and the fact that the “least burdensome” requirement in the statute means FDA shifts some data collection to post-market studies.
The primary contribution of this piece is Part IV. In addition to arguing that CDRH staff and funding should be restored to pre-2025 levels, this section offers several possible reforms for the device framework: (1) mandatory review of PMA-approved devices every 5 to 7 years (suggested, he notes, by Rome-Kramer-Kesselheim, in JAMA); (2) requiring clinical data with a PMA supplement once the number of incremental modifications to an approved device exceed a certain number (which he also put forward in Trading Safety in the BYU Law Review); (3) requiring clinical data with a new device (modification) if its “ancestor” was recalled; (4) requiring new clinical data for PMA supplements for device types with “information-poor knowledge bases that are undergoing rapid innovation”; and (5) rolling back the shift of data acquisition to the post-market period. Also, and intriguing: the suggestion that the funding constraints of the current moment might tip the scales for people otherwise opposed to agency reliance on industry user fees. Even more intriguing: enactment of a medical device excise tax. (On the device excise tax that was included in the Affordable Care Act, see this Congressional Research Service report. There was a four-year moratorium on its collection, and it was repealed in December 2019. A tax would, of course, go into the U.S. Treasury and require appropriation to FDA, so murky waters ahead …) Big ideas, though.
Rachel Sachs’s Regulating Healthcare Technologies in a Post-FDA World, which is forthcoming in the Northwestern University Law Review, is an entirely different exercise. I love this article, which has a thorough, careful, and expert discussion of the agency’s regulation of new prescription drugs — both historically and in the present moment — framed within the theories offered to justify that drug regulatory framework. She is thinking big, but the article is so easy to read, thanks to the time she took to structure her thinking: three theories that justify the drug regulatory framework, three real-world developments that could bring about a post-FDA world, three factors that will influence the impact of those real-world developments, and three principles for consideration “should we find ourselves in a post-FDA world” and in need of rebuilding.
To me, the conceptual heart of this Article is Part II (“How Ongoing and Stated Policy Decisions are Damaging FDA”), which discusses three real-world scenarios of concern. We are peering into Galadriel’s mirror, here; these are not yet things that have come to pass. But she speaks of (1) “the destruction of state capacity” — i.e., greater and greater reductions in force, retirements, and firings, with their inevitable impact on both institutional memory and the agency’s ability to perform its core functions; (2) the adoption of a safety-only approval standard (the arguments for which she describes as “incoherent” because, of course, safety is always relative); and (3) political control over premarket product review. And she explains how these developments would be inconsistent with the theoretical underpinnings of the agency’s new drug regulatory framework, especially consumer protection and information generation.
Although Part II is the conceptual heart, I think the real contribution — what’s not been said before, at least not quite this way — is Part III (“Situating FDA Within a Broader Institutional Context”). Professor Sachs takes up the question whether other stakeholders — such as regulators in other countries, insurers, and various non-profit organizations — might either exacerbate or mitigate the harms that she sees coming in the post-FDA world. For instance, she considers the possibility that insurers could serve as an independent check on FDA, if the agency authorizes products that turn out to be unsafe or ineffective (Type 1 errors). To give another example, after noting that the American Academy of Pediatrics is continuing to publish its own vaccine recommendations, she considers the “the potential for expert physician groups to serve as independent sources of information about new therapies.”
(That this might — would? — happen makes sense to me. As I wrote in 2018, in the early 1900s the American Medical Association developed a scheme for assessing drug effectiveness claims and granting its own seal of approval. It expected clinical data and developed a set of clinical trial design principles to govern support of therapeutic claims. Participation in this scheme was of course voluntary, but the AMA approval — and the organization’s thinking about clinical trial design and data analysis — played an important role during the years before Congress amended the statute to require proof of effectiveness in new drug applications.) Professor Sachs’s observation about expert physician groups playing a role in sharing information about new therapies dovetails nicely with this history, and it is echoed in her subsequent suggestion (Part V) that policymakers in a post-FDA world could consider ways of investing in internal agency capacity, such as through contracts with non-government entities to support the government’s work.
It’s a dog’s world, and we’re just living in it? Although the papers from Professor Horvath and Professor Sachs are my focus here, a paper from Ana Santos Rutschman, The Lyme Disease Vaccine: Regulation in Times of Misinformation, deserves a brief mention because it also considers the situation in which we currently find ourselves. Professor Rutschman, who writes extensively on vaccine law and policy, tells the story of the first (and long since discontinued) Lyme disease vaccine and worries about the fate of the newer vaccines under development. The shape of the story is mostly familiar, and the prognosis she offers is somewhat bleak.
If you’ve read much about vaccine law and policy, the story of LYMErix will not surprise you. Some of the commercial challenges were unique; for instance, ACIP members disparaged the vaccine (calling it a “yuppie” vaccine for “worried suburbanites” who “travel to Cape Cod”), and the group’s “lukewarm recommendation” was “highly unusual” (quoting Paul Offit). Some of the commercial challenges were not unique: some patients knew they were at high risk and were willing to get the vaccine, but the average person really didn’t know how to estimate his or her risk. At the time, tick-borne diseases were not as familiar to people as they are now. And the rest of the story is utterly familiar: allegations of vaccine-induced injury, a review of the adverse events by FDA and CDC that concluded otherwise, class-action litigation, extensive publicity, plunging sales, and market withdrawal.
Professor Rutschman moves on to discuss ongoing Lyme disease vaccine development projects, including candidates approaching (or in) the later states of development, but pauses to discuss what she describes as “erosion” in FDA’s commitment to “scientific criteria” and “procedural guardrails” especially as they relate to vaccines. Thus, she says, in a “best-case scenario” any new Lyme disease vaccines “will enter the market at a time of profound regulatory uncertainty, as well as amidst a deficit of vaccine trust-building mechanisms at the federal level.”
I’ll end on a positive note, though, with a picture of my English Setter (“Noodles”). Because you can get a Lyme disease vaccine … if you’re a dog.
FDA doesn’t regulate vaccines for animals! Although FDA (which is part of HHS) approves new animal drugs, the Department of Agriculture has jurisdiction over biological products for animals under the Virus-Serum-Toxin Act. For information about licensed veterinary biological products, look here.