U.S. Capitol Building at Night

Is Preemption the Cure for Healthcare Federalism’s Restrictions on Medication Abortion?

This post is an adaptation of an article published in the Harvard Social Impact Review.

By Allison M. Whelan

On June 24, 2022, the U.S. Supreme Court issued its decision in Dobbs v. Jackson Women’s Health Organization, overruling almost fifty years of precedent established by Roe v. Wade and reaffirmed by Planned Parenthood v. Casey. The tragic consequences of Dobbs are many, and all require urgent attention.

Post-Dobbs, states have complete control over the regulation of abortion, including medication abortion. Now more than ever, a person’s access to abortion and other essential reproductive health care services depends on their state of residence and whether they have the means to travel to a state that protects access to abortion care. As a result, the question of whether states can restrict or ban pharmaceuticals approved by the U.S. Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public

The consequences that result from state bans and restrictions on medication abortion reverberate across the U.S. healthcare system, representing just one example of “healthcare federalism” — the division of power between the federal and state governments in the regulation of health care.

Notwithstanding the state’s long-standing role in the regulation of health care and the practice of medicine, the changing nature of the provision of health care — which increasingly crosses state or even national lines — raises serious and urgent questions about the logic of continuing to show great deference to such state authority.

Healthcare federalism has undeniable benefits, such as enabling states to respond more efficiently to local needs. Nevertheless. a fractured state-by-state approach to healthcare regulation too often exacerbates deeply entrenched disparities within and between state populations. Specifically, state-level restrictions disproportionately harm vulnerable and historically marginalized communities, particularly people of color, low-income populations, persons with disabilities, and the LGBTQ+ community — the very same groups historically ignored, exploited, or abused by the U.S. healthcare system. In short, state bans and restrictions on essential healthcare services and medicines involve more than just matters of federalism. They concern life and death.

State pharmaceutical bans and restrictions — which are often medically unnecessary and instead based largely on policymakers’ moral and political views — impede the FDA’s mandate to protect and promote the public health. The FDA achieves its congressionally charged mission, in part, through its gatekeeping function as the primary regulator of pharmaceuticals in the United States. New drugs cannot be marketed in the United States until the FDA conducts a thorough and expert review and determines that the drug is safe and effective for its proposed use.

The FDA first approved mifepristone, in a regimen with misoprostol, for the termination of early pregnancy in 2000. Since that time, the FDA has consistently reaffirmed that the drug is safe and effective for terminating early pregnancy, as reflected by the Agency’s gradual easing of federal restrictions on mifepristone. In December 2021, an important milestone was achieved when the FDA removed the requirement that mifepristone be dispensed in person, thereby opening the door for dispensing mifepristone through the mail after a telemedicine appointment.

After Dobbs, U.S. Attorney General Merrick Garland made the position of the federal government clear, stating: “[T]he FDA has approved the use of the medication Mifepristone. States may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.” Nevertheless, disagreement and a lack of judicial guidance on this issue foreshadow battles yet to come.

Current law, policy, and judicial precedent, in conjunction with statements by Congress and the FDA, do not provide a clear answer as to whether federal law preempts state bans and restrictions on FDA-approved pharmaceuticals. The doctrine of federal preemption, under which federal law supersedes conflicting state laws, derives from the “Supremacy Clause” of the U.S. Constitution.

The U.S. Supreme Court has not addressed this issue directly, and one publicly-available federal court decision on a similar issue — a Massachusetts ban on an FDA-approved opioid — concluded that federal law did indeed preempt the state ban. This lack of clarity leaves access to FDA-approved pharmaceuticals vulnerable in all states. Importantly, the significance of the issue must not be dismissed merely because it affects a relatively limited number of FDA-approved drugs at this time. The regulation of politically and ethically controversial medical innovations, such as contraceptives and genomic and enhancement medicines, will likely foster similar frictions between federal and state authorities. Federalism tensions over the regulation of pharmaceuticals thus transcend abortion, raising important and urgent questions about whether and to what extent states should have the authority to restrict access to FDA-approved pharmaceuticals.

To address these issues and chart pathways forward, Congress should consider amending the federal Food, Drug, and Cosmetic Act to expressly preempt state pharmaceutical bans and restrictions. There are important nuances and details to this proposal, which are addressed more fully in a forthcoming article in the Harvard Journal of Law & Gender. Recognizing the need to strike a delicate balance between state and federal interests, the preemption need not be absolute. In appropriate circumstances, states could seek an exemption to address a state-specific public health need. This might justify, for example, state restrictions on an FDA-approved narcotic in a state with rates of opioid addiction and related deaths that exceed the national average. Yet absent further clarity from Congress, the FDA, and the Executive, the legality of state pharmaceutical bans and restrictions will be left to the discretion of the judiciary, an institution proving to be unreliable in the protection of individual rights and the promotion of equality.

The proposal to preempt state pharmaceutical bans and restrictions through legislation will face challenges. Many states will likely argue that such reforms curtail their long-held authority to regulate the practice of medicine. But what has been need not always be. There are reasons to respect past practices, but evolutions in medical practice, the increasingly national and even international scope of the practice of medicine, and the undeniable negative consequences caused by certain state pharmaceutical regulations make blind adherence to healthcare federalism nonsensical, unworkable, and even dangerous or life-threatening. Combatting deeply entrenched health disparities requires creative thinking, and this proposal provides an important tool in the fight to close these tragic gaps.

Allison M. Whelan, JD, MA Bioethics, is an assistant professor at the Georgia State University College of Law. She is an interdisciplinary scholar whose research and teaching encompass a broad set of medical, science, and social policy issues at the intersection of administrative law, food and drug law, health law, constitutional law, bioethics, and reproductive justice. She has published or has forthcoming articles in the Vanderbilt Law Review, Minnesota Law Review, Harvard Journal of Law & Gender, Washington & Lee Law Review, Illinois Law Review, Cornell Law Review Online, Fordham Law Review, and the Harvard Social Impact Review, among others. Allison is the author of multiple book chapters and has also published op-eds and commentary, including for Ms. Magazine, the Harvard Bill of Health, and the Philadelphia Inquirer.

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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