As readers know, FDA does not operate in a vaccuum; it has relationships with, and sometimes collaborates with, other federal regulators. It shares information with them, it may receive information from them, and sometimes it shares jurisdiction with another agency or shares responsibility for implementing a particular program. (For instance, both PTO and FDA play a role in implementing the patent term restoration provisions of section 156 of the Patent Act. Some of my work explores the FDA/PTO intersection.) Today I highlight two recent pieces of scholarship focusing on FDA and other regulators. Both, I think, reflect the same notion; as Professor Tammi Etheridge (who writes the second article) says, this work “belies the notion that all agency collaboration is good collaboration.”
[This blog is back, after a two-year pause. We’re starting with a review of important new scholarship relating to FDA law, but will move on to other topics.]
The first piece is Litigating Authority for the FDA by Joseph Daval, who graduated from Yale Law in 2021 and is serving as a fellow at the Program on Regulation, Therapeutics, and Law at Harvard Medical School and Brigham and Women’s Hospital. Daval’s paper looks at the relationship between, and relative roles of, FDA and the Department of Justice, in enforcement of the FDCA. This is an issue of immense importance to anyone practicing FDA law and, he persuasively shows, should be of interest to anyone focused on administrative law and the administrative state.
The short version is that although FDA refers cases for enforcement, DOJ makes the call whether and when to sue (and may pursue matters of its own choosing, i.e., even when FDA chose not to refer the matter). As matters progress, with FDA lawyers working alongside DOJ lawyers, the DOJ lawyers have a tremendous amount of control over the arguments made and over litigation strategy. Using a series of semi-structured interviews, Daval draws conclusions that will seem exactly right to most practitioners and agency lawyers:
(1) DOJ makes use of its authority to decline and delay FDA referrals and to direct key decision-making in litigation, limiting FDA’s preferred implementation of the Food, Drug, and Cosmetic Act; (2) the agencies have distinct, yet overlapping, enforcement priorities; and (3) DOJ control can result in more enforcement, with DOJ pursuing cases without consulting FDA, or over FDA’s objection, and pushing FDA to take on others.
The point, in the end, is that by giving DOJ this control, Congress allows DOJ — which has a very different mission and is responsible to different constituencies — to shape substantive policy. Daval writes,
The enforcement priorities of the agencies correspond to their structure, function, and missions. The prevention of fraud is central to the identify of DOJ as a law enforcement agency. DOJ’s budget and reputation depends on its percentage of courtroom wins and financial recoveries. FDA, by contrast, is at its core a public health agency. It is comprised predominantly of public health experts who think in terms of preventing harm and ensuring safety and confidence in medical products.
These differences lead to two interpretations of the underlying prohibitions on “adulteration” and “misbranding.” …
In the end, he recommends that Congress grant FDA independent authority over civil—but not criminal—litigation. I’m not entirely sure his findings don’t go all the way to letting FDA set the criminal enforcement agenda, especially because the agency tends to treat criminal prosecution as a last resort (and it has a lot of other tools at its disposal). U.S. Attorneys who can claim credit for the “headline-grabbing settlements [of off-label drug promotion cases] regularly reaching hundreds of millions of dollars” (quoting Daval) may not have the same priorities as FDA (public health and safety), and in my view there may be good reason for enforcement of FDA’s statute to align with FDA’s own priorities.
Also on the topic of FDA’s relationship with other agencies is What’s the Beef? The FDA, USDA, and Cell-Cultured Meat (forthcoming in the Washington & Lee Law Review), by Professor Tammi Etheridge at Elon University School of Law in my home state of North Carolina. Rather than the tension between FDA and DOJ over who should direct enforcement priorities for (all) areas within FDA’s jurisdiction, this relates to one of the substantive areas as to which jurisdiction and responsibilities are divided among agencies.
“Meat” and “meat products” are governed by the Meat Inspection Act, which is administered by FDA. If these are combined with other products in a processed food, the agencies share jurisdiction, but FDA traditionally refrains from exercising jurisdiction if the product contains more than 3% raw (2% cooked) meat. Hence, cheese pizza: FDA. Pepperoni pizza: USDA. (Totally rational, right?)
Enter cell-cultured meat: a food product that, she explains is “derived from bovine animal cell cultures (typically stem cells) that have been harvested from a healthy animal and grown by scientists in a lab.” Who has jurisdiction? Section II of Etheridge’s article tells the history. For a while, each agency insisted it had jurisdiction. Then they worked out a “joint regulatory framework” in which each plays a role (at different stages in the process, from the lab to the food we eat).
In section III, though, Etheridge argues that USDA should play no role at all, for several reasons. The first is a familiar argument about USDA oversight of meat, but it has particular salience here. I’ll quote her abstract here:
Not only is the Department tasked with maximizing agricultural industry profits (and minimizing losses), but it is also tasked with nourishing Americans (and improving nutrition and health). In the case of cell-cultured meat, these two goals are diametrically opposed.
She offers several additional arguments, including that the task here is better suited to FDA’s expertise and not particularly related to USDA’s primary mission of monitoring “the safety and sanitation of the nation’s farms, slaughterhouses, and meat processing and packaging plants.”
Etheridge joins a chorus of commentators who have argued that dividing responsibility for food between FDA and USDA is confusing and sometimes leads to decisions that are not fully aligned, as well as those who have raised concerns about USDA’s dual mission (which is a concern for some well beyond meat — e.g., commodities like corn).
I’d love to see more articles exploring the interactions and relationships among agencies within the executive branch. There’s a lot here to mine.