Scholars argue that federal drug agency actions should take precedence over conflicting state regulations.
How should courts handle state regulations that restrict access to pharmaceuticals previously approved by the U.S. Food and Drug Administration (FDA)? State restrictions on the prescription and distribution of FDA-approved medication abortion pills such as mifepristone have emerged as a flash point for novel questions about preemption, a legal doctrine requiring federal law to supersede state law in certain circumstances.
In a recent article, Catherine M. Sharkey, a professor at the New York University School of Law, and Daniel J. Kenny, a judicial law clerk at the U.S. District Court for the Southern District of New York, propose a framework for courts to use when navigating the “next preemption frontier” of state challenges to FDA actions through conflicting regulation. Sharkey and Kenny outline two main types of these challenges to FDA authority: direct and indirect.
Sharkey and Kenny describe the first category as direct legal opposition to FDA actions, typically on constitutional, statutory, or administrative grounds. Constitutional and statutory suits against FDA largely invoke the “major questions doctrine” by claiming that the agency exceeded its delegated authority, while administrative suits claim that an FDA action was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law,” in violation of the Administrative Procedure Act.
But FDA has “fairly ironclad” and unambiguous congressionally delegated authority, particularly in the field of drug approvals, according to Sharkey and Kenny. They maintain that courts seem hesitant to substitute their judgment for FDA’s scientific expertise in approving drugs. Although courts may probe the agency’s processes to support drug approvals and scrutinize the agency’s failures to adequately explain their judgments, Sharkey and Kenny contend that strong agency deference still wins the day.
Sharkey and Kenny consider indirect challenges to FDA actions—conflicting state regulation—a stronger threat to the agency’s drug oversight authority. They list several examples of states asserting their police power to enact health and safety laws limiting access to mifepristone in contradiction of the drug’s FDA approval. Some of these laws, for example, have banned remote, telemedicine appointments to prescribe mifepristone and ship it through the mail.
Although Sharkey and Kenny acknowledge the overlapping spheres of state and federal regulatory authority over both medicine and abortion, they describe state restrictions on drugs previously approved by FDA, such as mifepristone, as a “frontal assault” on the agency’s supremacy in regulating drug safety. They also note the potential disruption of the national market for pharmaceuticals if states are allowed to place limits on access to FDA-approved medications.
Noting both a lack of judge-made doctrine to help navigate these FDA preemption questions and the unlikely prospect of a legislative solution, Sharkey and Kenny offer an “agency reference model” as a framework to guide preemption inquiries. As a threshold matter, Sharkey and Kenny urge that no total state-level bans of FDA-approved drugs should be allowed because they subvert the agency’s congressional authorization to evaluate the safety and effectiveness of drugs.
Instead, Sharkey and Kenny contend that only state regulations that help ensure the safety and effectiveness of drugs and complement federal restrictions should survive preemption. Sharkey and Kenny argue that, if states find evidence of a drug’s risks of a different type or greater severity than previously assessed by FDA, they should submit such new evidence to FDA for its consideration before enacting their own regulations.
If a state regulation targets the same risks already identified by FDA, Sharkey and Kenny propose that courts should assess if the state regulation is complementary to FDA’s action. Sharkey and Kenny suggest that courts may consider what risk-benefit analysis FDA conducted, examine what restrictions the agency imposed, and solicit the agency’s input on whether a state regulation disturbs its risk assessment.
Sharkey and Kenny defend FDA’s primary regulatory authority by emphasizing the clear statutory authority of the agency to approve or reject pharmaceuticals based on their safety and effectiveness. They describe the need for uniform national drug regulation that only a federal agency can provide. In addition, Sharkey and Kenny contend that FDA’s drug approval process produces valuable clinical data that is not easily replicable at a state level. Still, they claim that, where FDA has not acted on a drug, states can step in to fill the void with safety regulation.
Sharkey and Kenny promote their agency reference model as a way to preserve federalism principles and enforce the U.S. Constitution’s Supremacy Clause when courts confront conflicting state and federal drug regulations.
