Evaluating FDA Preemption of State Drug Regulation – The Regulatory Review

Report on Federal and State Pharmaceutical Regulation and its Impact on Sustainable Development Goals

Introduction: Regulatory Conflict and Sustainable Development

A critical challenge has emerged regarding the legal preemption of federal law over state law, specifically concerning state regulations that restrict access to pharmaceuticals approved by the U.S. Food and Drug Administration (FDA). This issue directly impacts the advancement of the United Nations Sustainable Development Goals (SDGs), particularly SDG 3 (Good Health and Well-being) and SDG 16 (Peace, Justice and Strong Institutions). A recent analysis by scholars Catherine M. Sharkey and Daniel J. Kenny proposes a judicial framework to navigate this conflict, focusing on the case of mifepristone, an FDA-approved medication. The resolution of this conflict is essential for ensuring uniform access to healthcare and maintaining the integrity of national regulatory bodies.

Analysis of Challenges to Federal Regulatory Authority

The authority of the FDA in drug regulation faces two primary forms of challenges, which have significant implications for public health infrastructure and the rule of law, cornerstones of the SDGs.

• Direct Challenges: These are legal actions against the FDA on constitutional, statutory, or administrative grounds. Such challenges often invoke the “major questions doctrine” or allege violations of the Administrative Procedure Act. However, they are frequently unsuccessful due to the FDA’s clear congressional mandate and the judiciary’s deference to its scientific expertise. This deference supports SDG 16 by respecting the role of effective and specialized institutions.
• Indirect Challenges: These manifest as conflicting state-level regulations that limit access to FDA-approved drugs. States enact these laws under their health and safety powers, creating a fragmented regulatory landscape. This approach poses a more substantial threat to the FDA’s authority and directly undermines the goal of universal access to medicine as outlined in SDG 3. Such actions disrupt the national pharmaceutical market and challenge the principle of federal supremacy in ensuring drug safety and efficacy.

Implications for Sustainable Development Goals

The conflict between federal and state drug regulation has profound consequences for several SDGs.

SDG 3: Good Health and Well-being

• Target 3.7 (Universal Access to Sexual and Reproductive Health-Care): State restrictions on medications like mifepristone create significant barriers to essential reproductive healthcare services, directly contravening the objective of universal access.
• Target 3.8 (Universal Health Coverage): A patchwork of state laws impedes the achievement of universal health coverage by preventing equitable access to safe, effective, and affordable essential medicines for all citizens.

SDG 16: Peace, Justice and Strong Institutions

• Target 16.3 (Promote the Rule of Law): The preemption debate is fundamentally a question of the rule of law. Establishing a clear legal framework for resolving these conflicts is necessary to ensure consistent application of law and equal access to justice and healthcare.
• Target 16.6 (Develop Effective, Accountable Institutions): The FDA is a critical national institution responsible for public health. State actions that override its science-based decisions weaken its effectiveness and accountability, hindering the development of strong institutions at all levels.

Proposed Framework: The Agency Reference Model

To address this regulatory conflict in a manner that supports national health objectives and institutional integrity, Sharkey and Kenny propose an “agency reference model.” This framework provides a structured approach for courts to evaluate state regulations that conflict with FDA actions, thereby reinforcing the principles of SDG 16.

1. Prohibition of Total Bans: State-level bans of FDA-approved drugs should be disallowed, as they fundamentally subvert the FDA’s congressionally authorized mandate to determine the safety and effectiveness of pharmaceuticals for the nation.
2. Complementary Regulation Only: State regulations should only be permitted if they complement federal restrictions and genuinely contribute to the drug’s safety and effectiveness, rather than creating obstacles to access.
3. Primacy of FDA Review: If a state identifies new evidence of a drug’s risks, it should first submit this evidence to the FDA for consideration before enacting its own regulations. This respects the FDA’s role as the primary expert body.
4. Judicial Assessment of Complementation: Courts should assess whether a state regulation targeting risks already identified by the FDA is truly complementary. This involves examining the FDA’s risk-benefit analysis and soliciting the agency’s input on whether the state law disrupts its comprehensive regulatory scheme.

Conclusion: Upholding National Standards for Global Goals

The effective regulation of pharmaceuticals is paramount for public health and national stability. The FDA’s primary authority ensures a uniform, science-based standard for drug safety and efficacy, which is vital for achieving SDG 3. The agency reference model offers a path to preserve this essential federal role while respecting principles of federalism. By ensuring that state laws complement rather than contradict federal determinations, this framework strengthens the rule of law and the institutional capacity required to meet the Sustainable Development Goals, ensuring that all citizens have access to essential, life-saving medicines.

SDGs Addressed in the Article

SDG 3: Good Health and Well-being

• The article’s central theme is access to pharmaceuticals, specifically the FDA-approved medication mifepristone. The conflict between federal approval and state restrictions directly impacts the availability of essential medicines and healthcare services, which is a core component of ensuring healthy lives and promoting well-being. The text discusses the FDA’s role in evaluating the “safety and effectiveness of drugs” to protect public health.

SDG 5: Gender Equality

• The specific drug discussed, mifepristone, is used for medication abortion. Access to reproductive health services is a critical aspect of gender equality, empowering women and ensuring their bodily autonomy. State laws that “restrict access to pharmaceuticals” like mifepristone disproportionately affect women and their ability to make decisions about their reproductive health.

SDG 16: Peace, Justice and Strong Institutions

• The article is fundamentally about the legal and institutional frameworks governing drug regulation in the United States. It analyzes the conflict between federal (FDA) and state institutions, the role of the courts, and legal doctrines like preemption and the Supremacy Clause. The proposal of an “agency reference model” is an attempt to create a more effective and accountable institutional process for resolving these conflicts.

Specific SDG Targets Identified

SDG 3: Good Health and Well-being Targets

1. Target 3.7: Ensure universal access to sexual and reproductive health-care services.

   The article directly relates to this target by focusing on state-level restrictions on mifepristone, a medication used for abortion, which is a key component of sexual and reproductive healthcare. The discussion of “State restrictions on the prescription and distribution of FDA-approved medication abortion pills” highlights the barriers to achieving universal access.

2. Target 3.8: Achieve universal health coverage, including access to safe, effective, quality and affordable essential medicines for all.

   The core issue is whether states can limit access to a medication that the FDA, the national authority, has deemed safe and effective. The article notes the potential for these state actions to cause “disruption of the national market for pharmaceuticals,” thereby threatening universal access to essential, FDA-approved medicines.

SDG 5: Gender Equality Targets

1. Target 5.6: Ensure universal access to sexual and reproductive health and reproductive rights.

   This target is directly addressed through the article’s focus on the legal battles over mifepristone. The conflict between the FDA’s approval and state laws that “have banned remote, telemedicine appointments to prescribe mifepristone” is a clear example of a challenge to universal access to reproductive health and the exercise of reproductive rights.

SDG 16: Peace, Justice and Strong Institutions Targets

1. Target 16.3: Promote the rule of law at the national and international levels and ensure equal access to justice for all.

   The article explores a fundamental conflict in the rule of law: whether federal law supersedes state law (“preemption”). The lack of a clear judicial doctrine creates legal uncertainty and unequal access to healthcare depending on state jurisdiction. The entire discussion is about how courts should “handle state regulations that restrict access to pharmaceuticals” to ensure a consistent application of the law.

2. Target 16.6: Develop effective, accountable and transparent institutions at all levels.

   The analysis centers on the effectiveness and authority of the FDA as a national institution. The authors defend the FDA’s “fairly ironclad and unambiguous congressionally delegated authority” and propose an “agency reference model” to guide courts, aiming to make the judicial and regulatory process more effective and predictable when state and federal regulations conflict.

3. Target 16.B: Promote and enforce non-discriminatory laws and policies for sustainable development.

   The article implicitly addresses this target by discussing the need for “uniform national drug regulation.” State-by-state restrictions create a patchwork of laws that can be seen as discriminatory, as they deny access to approved healthcare options in some states but not others. Enforcing federal preemption in this context would promote a non-discriminatory national policy on access to approved medicines.

Indicators for Measuring Progress

SDG 3 Indicators

• Implied Indicator: The number and scope of state laws and regulations that restrict access to essential medicines approved by a national regulatory authority (like the FDA). The article provides examples, such as laws that “banned remote, telemedicine appointments to prescribe mifepristone and ship it through the mail,” which could be tracked to measure barriers to healthcare access.

SDG 5 Indicators

• Implied Indicator (related to official indicator 5.6.2): The number of sub-national jurisdictions (states) with laws and regulations that limit or create barriers to accessing sexual and reproductive healthcare services, such as medication abortion. The article’s entire premise is based on the existence of these “conflicting state regulations.”

SDG 16 Indicators

• Implied Indicator: The number of legal challenges and court cases concerning the preemption of state law by federal regulatory actions in the healthcare sector. The article describes this as the “next preemption frontier,” indicating a growing area of legal conflict that reflects institutional friction.
• Implied Indicator: The existence and adoption of clear legal frameworks or models, such as the proposed “agency reference model,” to resolve jurisdictional conflicts between national and sub-national institutions. The article highlights a “lack of judge-made doctrine,” the absence of which is an indicator of institutional weakness.

Summary Table of SDGs, Targets, and Indicators

Source: theregreview.org