Notice & Comment

Ad Law Reading Room: “FDA Leads, States Must Follow,” by Catherine M. Sharkey and Daniel J. Kenny

Today’s Ad Law Reading Room entry is “FDA Leads, States Must Follow,” by Catherine M. Sharkey and Daniel J. Kenny, which is forthcoming in the Washington University Law Review. Here is the abstract:

As deference to administrative agencies has steadily come under attack, the FDA is a desert oasis. Courts have long deferred to the agency’s scientific expertise, particularly on matters of drug safety and effectiveness. But now, post-Dobbs, the FDA faces what this Article frames as two distinct types of legal challenges: (1) direct challenges to FDA actions, including drug approval decisions, and (2) indirect challenges to the primacy of FDA actions that arise in the context of preemption disputes over the extent to which state regulations conflict with federal regulatory schemes. Direct challenges to FDA actions are relatively rare and almost never succeed. Indirect challenges posed by state bans or restrictions on FDA-approved drugs amount to a new preemption frontier facing courts.

Where Congress has not definitely addressed the federal-state interaction, this Article marshals the longstanding record of judicial deference to the FDA’s scientific expertise; the agency reference model drawn from existing implied preemption doctrine; principles embedded in the statutes and regulations governing FDA approval of drugs; and normative arguments about the need for national uniformity to build a novel preemption framework to be enforced by courts in which the FDA’s risk calculus leads and the states must follow.

Under our framework, states cannot ban FDA-approved drugs, whether due to health and safety or political or moral objections. State restrictions that subvert the FDA’s risk calculus, such as bans of abortion-inducing drugs or telehealth proscriptions, cannot withstand preemption. But, where the FDA has not acted, states can fill the void either with gap-filling drug safety regulation, or—as the proliferation of gender-affirming care bans forewarns—the bootstrapping of politically-motivated decisions under the guise of health and safety.

Our framework whereby FDA leads and states must follow not only promotes national regulatory uniformity but—equally significantly—it harnesses the FDA’s capacity to incentivize the generation of high-quality clinical data about drugs’ safety and effectiveness.

May states prohibit drugs, such as mifepristone, used for abortions? When, if ever, might states’ general abortion bans conflict with federal law? What about state restrictions on gender-affirming care?

Questions such as these provide fodder for some of the most contentious disputes facing the American regulatory system today, and they have placed the preemptive effect of FDA drug approval decisions on center stage. This article takes up the challenge of answering them. It develops a nuanced framework, building on Sharkey’s prior work, for courts to use in evaluating potential conflicts between state regulations and determinations made by federal regulators. In doing so, it makes a persuasive case for an approach that is sensitive to the benefits of national uniformity and expertise-driven decisionmaking, as well as to the reality of states’ police power.

The Ad Law Reading Room is a recurring feature that highlights recent scholarship in administrative law and related fields. You can find all posts in the series here.

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