Sharkey & Kenny on the Role of the FDA

Cathy Sharkey & Daniel Kenny have posted to SSRN FDA Leads, States Must Follow.  The absract provides:

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 regulatory 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.