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# ‘Agency Reference Model’ Suggested for ‘Next Level Preemption’
- URL: https://www.fdaweb.com/agency-reference-model-suggested-for-next-level-preemption/
- Published: 2025-11-26T12:00:00.000Z
- Updated: 2026-09-14T15:27:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160291

A recent *Washington University Law Review* article suggests a framework the courts could use for the “next preemption frontier” of state challenges to FDA actions through conflicting regulations. The article, by New York University School of Law professor **Catherine Sharkey** and federal court for the Southern District of New York judicial law clerk **Daniel Kenny**, was outlined in [*The Regulatory Review*](https://www.theregreview.org/2025/11/26/cotton-evaluating-fda-preemption-of-state-drug-regulation/?ref=fdaweb.com)(contains a link to the original journal article).

Sharkey and Kenny describe both direct and indirect challenges to FDA’s authority. They consider direct legal opposition to FDA actions, often based on constitutional, statutory, or administrative grounds. They write that the agency has “fairly ironclad” and unambiguous congressionally delegated authority, particularly over drug approvals, and say that courts seem hesitant to substitute their judgment for FDA’s scientific expertise in approving drugs.

Indirect challenges to FDA actions through conflicting state regulation pose a stronger threat to the agency’s drug oversight authority, the article maintains. The authors list several examples of states asserting their police power to enact health and safety laws limiting access to the medical abortion drug mifepristone in contradiction of FDA’s approval. “Some of these laws, for example, have banned remote, telemedicine appointments to prescribe mifepristone and ship it through the mail,” the *Regulatory Review* article says.

Sharkey and Kenndy offer an “agency reference model” as a framework to guide court preemption inquiries. As a threshold matter, they say, no total state-level bans of FDA-approved drugs should be allowed because they subvert the agency’s congressional authorization to evaluate drug safety and effectiveness. They also discuss the need for consistent, nationwide, federal regulation of drug safety and effectiveness.

The authors say that only state regulations that help ensure the safety and effectiveness of drugs and complement federal restrictions should survive preemption. They say 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 evidence to the agency for its consideration before enacting their own regulations.

If a state regulation targets the same risks already identified by FDA, Sharkey and Kenny suggest that courts should assess if the state regulation is complementary to FDA’s action. Courts may consider, they say, 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.

The *Regulatory Review* says 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.