On August 18, 2022, GenBioPro, Inc. voluntarily dismissed its federal lawsuit against a Mississippi state official, thereby abandoning its challenge to a restrictive Mississippi law on medication abortion. GenBioPro is a manufacturer of generic mifepristone — the drug approved by the U.S. Food and Drug Administration (FDA) in combination with misoprostol for the termination of pregnancy up to ten weeks gestation. Evan Masingill, president of GenBioPro, asserted that the company is adjusting its strategy “given the changed national landscape,” but that its fight is not over. GenBioPro initially filed suit against Mississippi in October 2020, arguing that Mississippi’s restrictions on medication abortion were unconstitutional because they were stricter than the requirements set by the FDA, and thus preempted by federal law. The premature ending of this case represents a missed opportunity to provide clarity about whether states can restrict, or even ban, drugs that the FDA has approved as safe and effective. Yet there is hope: counsel for GenBioPro recently announced that the company is searching for a new court to revive its challenge.

The doctrine of federal preemption, under which federal law supersedes conflicting state laws, derives from the “Supremacy Clause” of the U.S. Constitution. Over the past few years, as the battle over abortion heated up and states increasingly targeted medication abortion, scholars have grappled with the question of whether states can restrict or ban pharmaceuticals approved by the FDA. This question is now top of mind for lawyers, scholars, policymakers, and the public in the wake of the U.S. Supreme Court’s decision to overrule Roe v. Wade and Planned Parenthood v. Casey in Dobbs v. Jackson Women’s Health Organization.

The FDA represents the primary regulator of pharmaceuticals in the U.S., guided by the Agency’s congressionally charged mission to protect and promote the public health. FDA achieves this mission, in part, through its gatekeeping function, pursuant to which new drugs cannot be marketed in the U.S. until the FDA conducts a thorough expert review and determines that the drug is safe and effective for its proposed use. Since the FDA’s approval of mifepristone in 2000, the FDA has consistently reaffirmed that the drug provides a safe and effective method for terminating early pregnancy, as reflected by the Agency’s continual and gradual easing of federal restrictions on the use and distribution of the drug. 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.

State bans and restrictions on FDA-approved pharmaceuticals — which are often medically unnecessary and instead based largely on policymakers’ individual moral and political views — impede the Agency’s mandate to protect and promote the public health. State pharmaceutical regulations and restrictions carry pernicious consequences. They disproportionately impact vulnerable and historically marginalized communities, particularly people of color, low-income populations, persons with disabilities, and the LGBTQ+ communities.  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 U.S. Supreme Court has not addressed this issue squarely, 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.

The end of the GenBioPro litigation will not be the end of the issue. On the contrary, state encroachment on the FDA’s regulatory authority over mifepristone foreshadows additional preemption conflicts on the horizon. After the decision in Dobbs, U.S. Attorney General Merrick Garland made the position of the Department of Justice 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.” Disagreement and a lack of judicial precedent on this issue, however, set the stage for many battles to come.

The issue presented by state bans and restrictions on medication abortion reverberates 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 regulating 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 benefits, such as by allowing states to respond more efficiently to local needs, but a fractured state-by-state approach to healthcare regulation too frequently exacerbates deeply entrenched health disparities within and between state populations.

As a result of Dobbs, the states now have complete control over the regulation of abortion. This means that perhaps more than ever before, a person’s access to abortion and other essential reproductive health care depends on their state of residence and whether they have the means to travel to a state that protects access to abortion care. Fierce and ongoing battles over abortion, contraception, and myriad other healthcare matters raise thorny questions that require new legal, regulatory, and policy frameworks. These conflicts demand serious consideration about whether healthcare federalism remains necessary or wise. State bans and restrictions on essential healthcare services and medicines like medication abortion, involve more than just matters of federalism. They concern life and death.

The lack of clarity about whether states may ban or impose significant, sometimes insurmountable, barriers to FDA-approved pharmaceuticals, and states’ continual encroachment on the FDA’s authorities, leave access to FDA-approved pharmaceuticals vulnerable in all states. This is particularly true in states with politicians eager to push back against the federal government. The import and urgency of the issue must not be dismissed merely because it affects a relatively limited number of FDA-approved drugs at this time. Given their politically and ethically controversial nature, the regulation of future medical innovations, such as 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 pharmaceuticals that the FDA has determined to be safe and effective.

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. 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. But 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 courts, an institution proving to be unreliable in the protection of individual rights and the promotion of equality.

The proposal to legislatively preempt state pharmaceutical bans and restrictions 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. 

About the Author:

Allison M. Whelan 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, health and FDA 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, and Fordham Law 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.