Sep 29, 2025
Diana Kasdan speaks with Bloomberg Law about how California protects reproductive care providers
The Promise of Reproductive Freedom Amendments: An Analysis of Reproductive Freedom Amendments and Their Impact on Anti-Abortion Laws
September 30, 2025 12:00 PM - 1:00 PM

On September 30th at 12 pm PST, join CRHLP for State Policy & the Future Physician: Impacts on Education, Care, and Well-being, a moderated discussion bringing together experts to examine how state policies are shaping medical education, care provision, well-being, and decision-making among medical students and residents.

This discussion, moderated by CRHLP Research Analyst Leslie Serrano, MPH with feature Pamela Merritt, Executive Director of Medical Students for Choice, Dr. Jody Steinauer, Director of UCSF Bixby Center for Global Reproductive Health and Director of Kenneth J. Ryan Residency Training Program in Family Planning, and Lara Stemple, Senior Scholar with the Center on Reproductive Health, Law, and Policy and Assistant Dean for Graduate Studies and International Programs at UCLA Law.

On August 27th, 2025, UCLA Law Center on Reproductive Health, Law, and Policy (CRHLP) and Advancing New Standards in Reproductive Health (ANSIRH) at UCSF submitted a letter on behalf of more than 260 researchers to the U.S. Food and Drug Administration (FDA).

On May 29-30, 2025, UCLA Law’s Center on Reproductive Health, Law, and Policy, in partnership with the Center for Reproductive Rights, convened over two dozen scholars, advocates, practitioners, and experts on maternal health and birth justice.

The goal: To identify areas where constitutional protections are lacking or inconsistent and brainstorm how to develop and expand legal theories that support rights during pregnancy, birth, and postpartum.  

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Convening Readings

 

 

Legal and Maternal Health Background Materials

Scholarship

Recent News Coverage

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Additional Recommended Readings

 

 

Articles, Guides, Reports

Books

Below are summaries and links to legal scholarship published after the Dobbs decision that address the role of history and tradition in analyzing and advancing reproductive rights.

Articles and Chapters

Bernick, Evan D. and Jill Wieber Lens, Original Public Meaning and Pregnancy’s Ambiguities, Michigan Law Review (2024) 

This article critically examines and refutes originalist claims that the Fourteenth Amendment includes prenatal personhood. Responding to arguments advanced in Dobbs v. Jackson Women’s Health Organization and related efforts to constitutionalize fetal rights, the authors argue that such claims misrepresent the historical, social, and legal context of pregnancy in 1868. They posit that any serious inquiry into the public meaning of the Fourteenth Amendment requires inquiry into the public understanding of pregnancy and abortion when the Amendment was ratified in 1868. Drawing on medical and legal history, and importantly lived experience, the article demonstrates that pregnancy at the time was medically ambiguous, socially fluid, and legally inconsistent—particularly before quickening, when pregnancy could not be reliably diagnosed and miscarriage was common and indistinguishable from abortion. Further, the authors refute the possibility that historical legal usage of the word “person” encompassed prenatal personhood. They show how criminal, tort, and property law of the time recognized prenatal existence for narrow purposes and does not support the constitutional claims of prenatal personhood proponents. The article concludes by warning that ignoring the social context and ambiguities of pregnancy as understood in 1868 –and that persist today-- risks legitimizing increased surveillance and criminalization of pregnancy loss in the post-Dobbs legal landscape. 

Davis, Martha F., Slavery, “Inalienable Rights,” and Abortion in State Constitutions, Syracuse Law Review (2025)

This article examines how state constitutional history and framers’ intentions regarding expansive inalienable rights provisions, and their relationship to the anti-slavery movement, can inform state constitutional interpretation in abortion cases. Using Indiana as a case study, Davis demonstrates the importance of a thorough exploration of the specific history and meaning of state constitutional provisions, addresses the interconnections between the provisions that protect inalienable rights and those that bar slavery more directly, and proposes these provisions should be viewed together and understood to protect personal autonomy, including decisions regarding procreation. Davis cautions, however, that historical evidence is just one part of a constitutional analysis and courts are not bound to repeat history that embodies deep and offensive prejudices.

Davis, Martha F., Annotated Bibliography: “Persons Born” and the Jurisprudence of “Life”, Boston University Law Review Online (2024)

This annotated bibliography reviews U.S. legal sources, including scholarship and cases, that interpret and apply the meaning of the word “life” as it appears in the context of the substantive aspects of due process in federal and state constitutions and in inalienable rights clauses appearing in many state constitutions

The bibliography sets out legal scholarship and caselaw relevant to the right to life, focusing on the rights of pregnant persons in the context of abortion. Consideration of fetal life is outside the scope of this bibliography. Part III provides the historical background of references to “life” relevant to both the federal and state constitutions’ due process and inalienable rights clauses. This Part also includes discussion of dictionary definitions of “life” pertinent to both federal and state constitutional provisions. Part IV turns to scholarly analyses and selected case law illuminating the federal due process protections for “life.” Following that, Part V embarks on a similar review of interpretations of “life” in scholarly commentaries and case law implicating state constitutions, including both state due process and inalienable rights clauses.

Franklin, Cary, History and Tradition’s Equality Problem, The Yale Law Journal Forum (2024)

The Court overturned Roe v. Wade after finding that the right to abortion is not “deeply rooted in the Nation’s history and traditions.” This Essay builds on the critical literature by identifying a key feature of the Court’s new history-and-tradition test for substantive due process cases that has not yet attracted significant attention: outcomes in these cases delivered by this test are often actually, or additionally, driven by hidden, contemporary judgements about equality.

Franklin, Cary and Reva B. Siegel, Equality Emerges as a Ground for Abortion Rights in and after Dobbs, in Roe v. Dobbs: the Past, Present, and Future of a Constitutional Right to Abortion (Oxford University Press 2024)

In this chapter, Franklin and Siegel posit the Dobbs decision and repudiation of Roe and Casey is a time of transition for the form of abortion rights, rather than a time of their abolition. The authors propose equal protection as an alternative ground for protecting abortion rights and as a powerful tool for critically probing the ways that anti-abortion jurisdictions claim to protect life. In making this argument, Franklin and Siegel show how Dobbs misinterprets the past and present logic of abortion bans. Specifically, they examine the historical foundations of abortion regulation to argue that laws banning abortion have long served dual purposes: protecting fetal life and enforcing gendered norms about women’s roles in family and society. Drawing on the historical record of nineteenth-century campaigns to criminalize abortion, they show that early abortion laws were deeply intertwined with efforts to reinforce women’s maternal and marital obligations, often justified through appeals to “natural” sex roles.  

The authors argue that this history should inform a modern equal protection analytic to better respond to the dual purpose of abortion laws, and address how states seek to restrict women’s civic status and instrumentalize their lives in the service of family care. Franklin and Siegel contend that laws regulating pregnancy, including abortion, should be scrutinized for impermissible reliance on sex-role stereotyping and failure to pursue less restrictive means of protecting potential life. And they conclude that a faithful application of equal protection doctrine would give rise to an anticarceral presumption, by which states must protect life in ways that do not coerce those who resist maternity or traditional sex roles and that are compatible with women’s equal citizenship. 

Goodwin, Michele, Distorting the Reconstruction: A Reflection on Dobbs, Yale Journal of Law and Feminism (2023)

The Dobbs decision offers an opportunity to revisit the damaged path to reproductive freedom, dating back to American slavery and bridge pathways forward with better understanding. This Essay offers a reflection on Dobbs, speaking to the origins of reproductive autonomy and justice concerns that preexisted Reconstruction. This Essay argues that by examining the antebellum archive, a different type of slavery and involuntary servitude come into view, namely the involuntary reproductive servitude imposed on Black girls and women.

Goodwin, Michele, Opportunistic Originalism: Dobbs v. Jackson Women’s Health Organization, Supreme Court Review (2022)

In its Dobbs decision, the Court undermined the rule of law in three critical aspects. First, it eliminated an established right that for nearly fifty years served as a crucial element of women’s civil liberties, one no less vital than a man’s constitutional right to be free from the state dictating his reproductive destiny. Second, in overturning Roe, it erased “a right that has safeguarded women’s ability to participate fully and equally in society.” Third, as discussed in this Essay, the Court “renounced this fundamental right, which it had repeatedly recognized and reaffirmed.” This Article argues that Dobbs is rooted in opportunistic originalism, whereby the Court implies its commitment to text, original meaning, and long, unbroken ties to tradition, but seriously veers from that methodology or performs its adjudication in such a neglectful and unsystematic manner that it belies fidelity to the methodology.

Greer, Anna, Women Seldom Make History and Tradition: Patriarchal Originalism in Dobbs, DePaul Journal for Social Justice (2023)

This Note juxtaposes New York Rifle & Pistol Association v. Bruen with Dobbs to examine the originalist methodology used in both cases and expose how superficially Dobbs treated the history and tradition of abortion.

Hutchinson, Darren Lenard, Thinly Rooted: Dobbs, Tradition, and Reproductive Justice, Arizona Law Review (2023)

This Article examines the influence of precedent, politics, and ideology on the content of constitutional law and argues that pro-choice advocates must utilize the political process to restore abortion as a fundamental right. As an alternative to the analysis in Dobbs, this Article recommends a more democratic approach to substantive due process that incorporates perspectives of historically marginalized voices. A new democratic approach could justify expanding rights to protect the most vulnerable members of society and move beyond the narrow conception of reproductive freedom as a negative liberty interest.

Mayeri, Serena, The Critical Role of History After Dobbs, Penn Journal of American Constitutional History (2024)

This essay explores critical roles for history in legal, constitutional, and political arguments about reproductive freedom and democracy after Dobbs. These critical approaches define differently the historical voices and sources that matter; the constitutional principles and lessons to be drawn from the past; and the roles that history and tradition should play in shaping our present and future. Critical histories read the Reconstruction Amendments as a mandate for emancipation and for the eradication of all forms of bodily and reproductive coercion. They elevate the voices of those who long were excluded from political participation and place abortion restrictions in a longer history of reproductive control and anti-democratic political traditions. Critical histories can and do inform the interpretation of state as well as federal constitutional provisions in and outside of court. From courtrooms, legislatures, and campuses to workplaces, street protests, and dinner tables, these histories play a more crucial role than ever in informing legal and political discourse about reproductive justice and the future of democracy.

McGowan, Miranda, The Democratic Deficit of Dobbs, Loyola University Chicago Law Journal (2023)

McGowan argues that Dobbs’s originalist history and tradition approach is fundamentally undemocratic and at war with the ideal of popular sovereignty. This Article demonstrates that the history surrounding women and abortion in the nineteenth century makes any popular sovereignty justification for Dobbs’s originalism impossible—as well as anachronistic and incoherent. The positive law protections for abortion or contraception that Dobbs demands never would have existed in the nineteenth century for reasons having nothing to do with “the people’s” views on abortion. Dobbs’s originalist error cannot remain confined to abortion if its methods are applied consistently. The Court claimed that Dobbs does not portend a reversal of other fundamental rights cases. If true, that fact condemns Dobbs as a selective application of its supposed premise—which is to say as a political act of judicial hypocrisy.

Miligan, Joy and Bertrall L. Ross II, We (Who Are Not) the People: Interpreting the Undemocratic Constitution, Texas Law Review (2023)

In this Article, the authors argues that the undemocratic nature of the Constitution must be addressed in interpreting the document. Interpreters can exacerbate or ameliorate the Constitution’s democratic flaws; the methods they select may entrench old forms of political exclusion or help equalize rights and status across the citizenry. To illustrate, the authors offer a case study of the perils and possibilities of interpretation, focusing on unenumerated rights. Such rights may have been unwritten because they were liberties commonly exercised by white men as full citizens, and hence could be assumed. Or they may have been unwritten because they mattered primarily for politically excluded populations and therefore could be ignored. The authors show that the Supreme Court’s recent adoption of an approach to unenumerated rights resting on “history and tradition” unjustifiably reinforces prior undemocratic conditions. As a corrective, the Article advocates a set of interpretive steps designed to ameliorate the Constitution’s democratic flaws and advance equal citizenship.

Murray, Melissa, Making History, The Yale Journal Forum (2024)

The October Term 2021 was a momentous one for the United States Supreme Court. In a series of decisions, the Court overturned two long-standing precedents, guaranteeing the right to abortion, expanded the scope of the Second Amendment, and appeared to cosign the Establishment Clause to the dustbin of history. This Collection focuses on the methods by which the Court produced that first overhaul: specifically, on the state-counting methodology employed in Dobbs. Perhaps to soften the blow of this jurisprudential shift, the Court invoked some of its most lauded landmark decisions – decisions that are well-known for conferring rights and incorporating once-excluded constituencies into the polity. The Court’s nod to these earlier decisions was no coincidence. Indeed, it was likely an effort to cast its rights – stripping decision in Dobbs as a descendant of the earlier decisions’ rights-conferring moves. In blunter terms, the Court invoked history while undoing it, raising a key question: what does it mean for the Court to “do history”? That is the core premise and question at the heart of the four essays comprising this Collection.

Siegel, Reva B., and Mary Ziegler, Abortion’s New Criminalization – A History-and-Tradition Right to Healthcare Access After Dobbs, Virginia Law Review (2025)

Since Dobbs reversed Roe as contrary to the nation’s history and traditions, efforts to ban abortion appear as calls for a return to tradition. But criminalization after Dobbs is not a return to the past; it is a new regime, in certain respects less restrictive, and in others far more so. Today, states criminalize access to urgently needed health care for pregnant patients in ways they never have before. The authors show that the nation has long had a tradition of exempting critical forms of health care from criminalization, that this tradition extended to abortion law, and that it was expressed in the many state laws cited in Dobbs’s appendices, as well as in the text and case law of the Comstock Act. This Article shows that this tradition extended across jurisdictions and over time. The authors demonstrate that under Dobbs and Washington v. Glucksberg, such a tradition can guide interpretation of the Constitution’s liberty guarantees, even if access was not historically termed a right. The Article shows that courts in states with abortion bans view history-and-tradition analysis of this kind as faithful to Dobbs and have begun to employ it under their own state constitutions.

Siegel, Reva B. & Mary Ziegler, Comstockery: How Government Censorship Gave Birth to the Law of Sexual and Reproductive Freedom, and May Again Threaten It, The Yale Law Journal (2025)

This Article offers the first legal history of the Comstock Act, a postal obscenity statute enacted in 1873, that reaches from its enactment to its post-Dobbs reinvention. Revivalists read the Comstock statute as a plain-meaning, no-exceptions, nationwide abortion ban. In countering revivalist claims, this Article recovers a lost constitutional history of the statute that explains why its understanding of obscenity and of items prohibited as nonmailable has evolved so dramatically in the 150 years since the law was enacted. Siegel and Ziegler show that the Comstock law was the first federal obscenity law to include writings and articles enabling contraception and abortion, condemning them along with erotica and sex toys as stimulants to illicit sex. At no point was this ban absolute. The law, by its terms and as enforced, policed obscenity rather than criminalizing health care. Even the judges who developed the most expansive Victorian interpretation of obscenity protected the doctor-patient relationship. The public’s repudiation of this expansive approach to obscenity as “Comstockery”—as encroaching on democracy, liberty, and equality—led to the statute’s declining enforcement and to cases narrowing obscenity and expanding access to sexual education, contraception, and abortion.

These developments were not only statutory; they were constitutional. Recovering this lost history changes our understanding of the nation’s history and traditions of sexual and reproductive freedom.

Siegel, Reva B., How “History and Tradition” Perpetuates Inequality: Dobbs on Abortion’s Nineteenth-Century Criminalization, Houston Law Review (2023)

In this Commentary, Siegel shows how the tradition-entrenching methods the Court employed to decide New York State Rifle & Pistol Ass’n, Inc. v. Bruen and Dobbs v. Jackson Women’s Health Organization intensify the gender biases of a constitutional order that for the majority of its existence denied women a voice in lawmaking and restricted women’s roles. The tradition-entrenching methods the Court employed to decide Bruen and Dobbs elevate the significance of laws adopted at a time when women and people of color were judged unfit to participate and treated accordingly by constitutional law, common law, and positive law. The methods the Court employs are gendered in the simple sense that they tie the Constitution’s meaning to lawmaking from which women were excluded and in the deeper sense that the turn to the past provides the Court resources for expressing identity and value drawn from a culture whose laws and mores were more hierarchical than our own.

Siegel, Reva B., Memory Games: Dobbs’s Originalism as Anti-Democratic Living Constitutionalism – and Some Pathways for Resistance, Texas Law Review (2023)

This Article examines originalism’s role in overruling Roe in Dobbs. Through this case study Siegel explores competing understandings of originalism. It shows that originalism is not simply a value-neutral method of interpreting the Constitution. Originalism is also a political practice whose long-term goal has been the overturning of Roe. As the conservative legal movement has developed originalism, judicial appointments matter critically to originalism’s authority, as do originalism’s appeals to constitutional memory to legitimate the exercise of public power. Examining these different dimensions of originalism’s authority, this Article shows that the conservative legal movement has practiced originalism as a form of living constitutionalism that makes our constitutional order less democratic in several important ways.

Siegel, Reva B., The Politics of Constitutional Memory, The Georgetown Journal of Law & Public Policy (2023)

This Article introduces the concept of constitutional memory to explain the silence in our law as it relates to the Nineteenth Amendment. Constitutional interpreters produce constitutional memory as they make claims on the past that can guide decisions about the future. It is the role of constitutional memory to legitimate the exercise of authority; but constitutional memory plays a special role in legitimating the exercise of authority when constitutional memory systematically diverges from constitutional history. Systematic divergence between constitutional memory and constitutional history can legitimate authority by generating the appearance of consent to contested status relations and by destroying the vernacular of resistance. Though women contested their lack of political authority in the constitutional order over two centuries, there is no trace of their arguments in constitutional law. To illustrate, the Article examines a long-running tradition of suffrage argument that began before the Reconstruction Amendments and continued in evolving forms after the ratification of the Nineteenth Amendment: that women needed the vote to democratize the family.

Siegel, Reva B., The History of History and Tradition: The Roots of Dobbs’s Method (and Originalism) in the Defense of Segregation, The Yale Law Journal Forum (2023)

In Dobbs, the Roberts Court claimed authority to overturn Roe v. Wade by comparing itself to the Warren Court in Brown v. Board of Education overturning Plessy v. Ferguson. This Essay challenges the claim that Dobbs is like Brown by recovering history the Court omitted in Dobbs—history that ties Dobbs’s history-and-tradition method to the defense of segregation. This Essay traces the rise and spread of an interpretive method—counting state laws in 1868—that finds the Constitution’s meaning fixed in the deep past, tied to the expectations, intentions, and practices of the Constitution’s ratifiers. It shows how this method—and forms of originalism and traditionalism that limit the Fourteenth Amendment’s meaning to its ratifiers’ expectations, intentions, and practices—arose in opposition to methods of interpreting the Amendment that recognize that application of its guarantees evolves in history.

Singer, Joseph William, Conflict of Abortion Laws, Northeastern University Law Review (2024)

When a resident of an anti-abortion state goes to a prochoice state to get an abortion, which law applies to that person? To the abortion provider? To anyone who helps them obtain the abortion? Since Dobbs overruled Roe, states have passed conflicting laws regarding abortion, and courts will need to determine whether anti-abortion states can apply their laws to persons or events outside their territory either through civil lawsuits or criminal prosecution. This article canvasses the major disputes likely to arise over conflicts of abortion law and the arguments on both sides in those cases. It addresses both common law analysis and the constitutional constraints on application of state law under the Full Faith and Credit Clause and the Due Process Clause, and it comes to some conclusions both about what laws should apply in different fact settings and how the choice of law analysis should proceed.

Tang, Aaron, After Dobbs: History, Tradition, and the Uncertain Future of a Nationwide Abortion Ban, Stanford Law Review (2023)

In this Article, Tang examines the legal future of both pathways in light of the Dobbs majority’s historical analysis. With respect to a federal statutory ban, many commentators have focused on Congress’s Article I authority. Yet if Congress has the power to codify a statutory right to abortion, it also has the power to ban it. The author thus considers a different possibility: Even if there were no deeply rooted liberty interest in abortion when the Fourteenth Amendment was enacted against the states, as Dobbs posits, such a history arguably did exist when the Fifth Amendment was enacted against the federal government. As Dobbs admits, every state at the Founding permitted abortion before quickening, at roughly sixteen to eighteen weeks of pregnancy. Dobbs’s own history-and- tradition test thus plausibly suggests a surprising result: A federal abortion ban—whether in the form of a new statute or a resurrected Comstock Act—may violate the Fifth Amendment Due Process Clause.

Tang, Aaron, Lessons from Lawrence: How “History” Gave Us Dobbs – and How History Can Help Overrule It, The Yale Law Journal Forum (2023)

Dobbs is not the first time the Supreme Court has relied on dubious history to deny a constitutional right of profound importance. When the Court rejected what it described as the right of “homosexuals to engage in acts of consensual sodomy” in Bowers v. Hardwick, it did so based on disputed historical claims about criminal sodomy laws in early America. Indeed, when the Court later overruled Bowers in Lawrence v. Texas, it openly confessed that Bowers’s “historical premises are not without doubt and, at the very least, are overstated.” This Essay explores three important lessons that reproductive-justice advocates can learn from Lawrence’s use of history to discredit Bowers. First, Lawrence shows that Dobbs is vulnerable to overruling because it, like Bowers, rests on faulty historical premises, including (but hardly limited to) Dobbs’s self-proclaimed “most important historical fact” that twenty-eight out of thirty-seven states banned abortion throughout pregnancy as of the Fourteenth Amendment’s enactment. Second, Lawrence suggests that these historical errors should undermine any claim Dobbs might make to stare decisis treatment. Finally, Lawrence reveals history’s limited utility in modern constitutional disputes. The problem with Dobbs’s dubious history, Lawrence teaches, is not that it represents the misapplication of a tractable test. The problem is that the history-and-tradition test Dobbs purports to apply is often deeply underdeterminate.

Townsend, Halley, Second Middle Passage: How Anti-Abortion Laws Perpetuate Structures of Slavery and The Case for Reproductive Justice, University of Pennsylvania Journal of Constitutional Law (2023)

This Article argues that anti-abortion laws in the former slaveholding states perpetuate structures of state control over the Black female body, exposes the connection between forced birth and slavery, and makes the case for constitutional pathways to resist anti-abortion laws and support reproductive justice. In making this set of arguments, Halley explores the history of the pro-life legal movement, including the racists history of abortion bans and medical experimentation. The article also traces the historical regulation of the Black female body back to the days of slavery and shows how modern-day abortion-bans replicate the very same historical laws and practices that supported slavery and gendered lynching, forced sterilization and eugenics of the post-slavery Jim Crow era.

Wilkson, Parker J., The Danger of Dobbs: Substantive Due Process, Fundamental Rights, and a Critique of the Theory of Historical Tradition, University of Florida Journal of Law & Public Policy (2025)

Central to the Supreme Court’s holding in Dobbs that the right to obtain an abortion would no longer be recognized as a fundamental right is the theory of historical tradition: the view that the only liberty interests recognized as fundamental rights under the Due Process Clause are those that are “deeply rooted in this Nation’s history and tradition.” This Note argues that the theory of historical tradition should not set the outer boundaries of fundamental rights. In demanding that a fundamental right find support in the Nation’s history and tradition, the Supreme Court imports a concept of liberty from a span of time in which many groups among our political community today were pathologized, denied basic political rights, or subject to state-sponsored discrimination.

Ziegler, Mary, The History of Neutrality: Dobbs and the Social-Movement Politics of History and Tradition, The Yale Law Journal Forum (2023)

By excavating the history around the history-and-tradition test used in Dobbs and the alternative pluralist approach it pushes to the side, this Essay reconsiders the meaning—and plausibility—of neutrality claims turning on the Dobbs Court’s use of history and tradition. Recovering past battles about the history-and-tradition test allows us to appreciate better how, over the decades, the idea of judicial neutrality has in fact been deployed non-neutrally, in the service of a shifting, and at times divisive, set of social values. Dobbs pays lip service to neutrality without achieving it.

Key amicus briefs and expert reports considering history and tradition in support of reproductive rights. Summaries and links to each filing are organized below as follows: State court amicus, federal court amicus, state court expert reports.

 

In the wake of the Dobbs decision, some courts have considered historical evidence in opinions that embraced more expansive interpretations of constitutional rights to protect abortion and related rights to varying degrees.  Here are key cases – primarily high court or final decisions – directly addressing history and tradition to reach rights-supportive decisions. Click on the case name below for a summary of the decision and its historical reasoning, and a link to the full opinion:   

Jul 03, 2025
Melissa Goodman talks to the San Francisco Chronicle about how the budget bill could impact access to reproductive healthcare

Our two legal trackers, the Mifepristone Litigation Tracker and Mifepristone Federal Action Tracker, provide timely, regularly updated, information on the status of current litigation and new federal administrative actions that could shape regulation of and access to mifepristone.

Background on Mifepristone

The Mifepristone Litigation Tracker

To date, mifepristone litigation includes:

9 cases filed to protect or expand current access:

3 cases filed to restrict current access:

The Mifepristone Litigation Tracker was last updated in November 2025. Download a PDF version here.

Case

 Court Date and Location Filed Summary of Challenge What’s at Stake Current Status

Florida et al. v. U.S. Food and Drug Administration et al., 

Case No. 7:25-cv-00126

 

U.S. District Court for the Northern District of Texas

December 9, 2025 

Texas 

 

Florida and Texas filed suit challenging FDA’s 2000 original approval of mifepristone, FDA’s decisions in 2016, 2021, and 2023 relaxing prior restrictions on mifepristone, and FDA’s 2019 and 2025 approvals of the generic form of the drug. Florida and Texas claim FDA’s decisions were not supported by adequate evidence and do not comply with the Comstock Act and thus violate the APA. The States seek to rescind the original and generic approvals of mifepristone, and reimpose restrictions on mifepristone that FDA has determined are medically unnecessary, including the pre-2021 requirement that it be dispensed in-person, and the pre-2016 restrictions requiring three office visits, limiting prescription of mifepristone to only certified physicians, indicating it could only be used for pregnancies up to 7 weeks (rather than 10 weeks), and requiring the reporting of all serious non-fatal adverse events to FDA.

 

 

This case could rescind FDA approval of mifepristone, drastically impacting access throughout the country. The case could also affect access to mifepristone by imposing burdensome restrictions on mifepristone FDA has determined are medically unnecessary, including requirements for in-person dispensing and office visits (which would prohibit mifepristone’s administration via telehealth) and limitations on which health care providers can prescribe mifepristone.

 

 

The case is currently pending in the U.S. District Court. 

The Center for Reproductive Rights v. U.S. Department of Health and Human Services, et al., Case No. 25-03023

U.S. District Court for the District of Columbia

 

September 5, 2025 

Washington, D.C.

Washington, D.C.The Center for Reproductive Rights (CRR) filed suit to compel FDA and HHS to comply with the Freedom of Information Act (FOIA) and produce information responsive to CRR’s request regarding FDA’s decision to review mifepristone, the process FDA will follow to review the medication, whether information from third parties will be considered during the review, and the influence HHS leadership may exert over FDA’s review of mifepristone and decision-making. CRR submitted its FOIA request in July 2025. HHS and FDA were required to notify CRR within 20 days of receiving the request of whether they would produce responsive records or their reasons for withholding them, but failed to do so.

Both FDA and HHS have said FDA is currently reviewing mifepristone, without providing any transparency to the public on what that review entails. Disclosure of the information CRR requests may shed light on the scope of FDA’s review and the sources of information FDA is considering, including whether it is considering an Ethics and Public Policy Center (EPPC) report that purports to undercut the longstanding determination that mifepristone is safe and effective, but has been largely debunked by the medical community for its flawed information and lack of peer review. Both FDA and HHS have said FDA is currently reviewing mifepristone, without providing any transparency to the public on what that review entails. medical community for its flawed information and lack of peer review.

 

The case is currently pending in U.S. District Court. FDA and HHS have not yet answered CRR’s complaint.

 

 

American Civil Liberties Union v. U.S. Food and Drug Administration, Case No. 25-03736

U.S. District Court for the District of Maryland 

November 13, 2025 

Maryland 

ACLU filed suit to compel FDA to comply with FOIA and produce information responsive to ACLU’s request regarding FDA’s review of and communications related to mifepristone. Plaintiff submitted its FOIA request on August 1, 2025. FDA was required to notify ACLU within 20 days of receiving the request of whether it would produce responsive records or its reasons for withholding them, but failed to do so. 

Both FDA and HHS have said FDA is currently reviewing mifepristone, without providing any transparency to the public on what that review entails. Disclosure of the information ACLU requests may shed light on the scope of FDA’s review and the sources of information FDA is considering, includingwhether it is considering an Ethics and Public Policy Center (EPPC) report that purports to undercut the longstanding determination that mifepristone is safe and effective, but has been largely debunked by the medical community for its flawed information and lack of peer review.

The case is currently pending in U.S. District Court. FDA has not yet answered ACLU’s complaint. 

Louisiana et al. v. U.S. Food and Drug Administration et al. 

Case No. 6:25-cv-01491 

U.S. District Court for the Western District of Louisiana 

October 6, 2025 

Louisiana 

Plaintiffs are the State of Louisiana and Louisiana resident Rosalie Markezich, who claims she was coerced by a former partner to take medication abortion that he ordered in her name and received by mail. Plaintiffs argue that the FDA’s 2023 Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, which removed the requirement of in-person dispensation for mifepristone, is unlawful under the Administrative Procedure Act because it is arbitrary and capricious and because it violates the Comstock Act and is thus contrary to law. They allege that as a result of the REMS, Louisiana suffers sovereign and economic harms and Markezich suffered physical and emotional harms.   

 

Plaintiffs request that the 2023 REMS be held unlawful, stayed, set aside, vacated, and permanently enjoined under the APA. 

This case could impact the ability to access mifepristone via telehealth by requiring the reinstatement of in-person dispensing only. This would drastically impact access to medication abortion nationwide, as nearly one in four of all abortions are accessed via telehealth.  

The case is currently pending in the U.S. District Court.

GenBioPro v. Raynes et al.,
Case No. 23-2194

(Final judgment entered—case closed.) 

U.S. Court of Appeals for the Fourth Circuit

(on appeal from U.S. District Court for the Southern District of West Virginia)

 

January 25, 2023

West Virginia

GenBioPro, a manufacturer of generic mifepristone, argues that federal law preempts West Virginia laws banning abortion in almost all cases and banning prescription of mifepristone by telemedicine because Congress authorized only FDA to impose restrictions on access to mifepristone.  GenBioPro also challenges as preempted West Virginia restrictions on mifepristone requiring counseling and a waiting period that are not currently in effect but would be reimposed if the state’s general abortion ban were struck down.  GenBioPro argues that the state’s ban and restrictions also burden interstate commerce in violation of the U.S. Constitution’s Commerce Clause.

The district court granted defendants’ motion to dismiss GenBioPro’s claim related to West Virginia’s general abortion ban, reasoning that the ban restricts when an abortion may be performed rather than how mifepristone may be prescribed and thus is not in conflict with or preempted by FDA’s regulations.  The court also concluded that the general abortion ban does not violate the Commerce Clase because it does not impede the flow of mifepristone nationally.  The court dismissed GenBioPro’s claims regarding the counseling and waiting period requirements since they are not currently in effect.

GenBioPro appealed the decision to the U.S. Court of Appeals for the Fourth Circuit.

This case affects access to mifepristone by deciding that states may impose burdensome restrictions on mifepristone beyond FDA’s regulations, including by banning mifepristone for its approved use in almost all circumstances and barring prescription via telehealth or otherwise making it more difficult to access.

On July 15, 2025, the U.S. Court of Appeals for the Fourth Circuit affirmed the decision below, leaving the state’s abortion ban in effect.  The court held that federal regulation of mifepristone under the Food and Drug Administration Amendments Act (FDAA) did not preempt the field of abortion regulation and did not create a conflict that made it impossible for plaintiff to comply with both the state law and federal law. The court held that West Virginia’s law prohibiting abortion is not preempted by or in conflict with federal regulation of abortion medication safety. It reasoned that FDA “has never been authorized to ‘regulate the practice of medicine’ or mandate that specific drugs be available.”

The court further  noted, however,  that its decision does not mean “FDA lacks any preemptive effect. States are certainly not free to dilute federal safety standards where they have been clearly established.” 

Final judgment was entered—this case is now closed.  

Bryant v. Moore,
Case No. 24-1617

U.S. Court of Appeals for the Fourth Circuit

(on appeal from U.S. District Court for the Middle District of North Carolina)

January 25, 2023

North Carolina

Plaintiff, a medical provider in North Carolina, asserts that federal law preempts North Carolina laws imposing additional restrictions on mifepristone beyond FDA’s requirements. 

The district court ruled that some of the challenged state-imposed restrictions—including laws requiring in-person prescribing, dispensing, and administering of mifepristone, prohibiting providers other than physicians from prescribing mifepristone, mandating the scheduling of an in-person follow-up appointment, and requiring non-fatal adverse event reporting to FDA—were preempted by federal law and invalid because FDA had implemented and then later affirmatively rejected and removed these restrictions. 

The district court upheld other challenged state requirements for an in-person advance consultation, ultrasounds, an in-person examination, blood type testing, and adverse event reporting to state health authorities, concluding that these provisions were not expressly considered and rejected by FDA or “focus more on the practice of medicine and a patient’s informed consent,” and thus are not preempted.  

Plaintiff, the defendant state Attorney General (who agrees with plaintiff that the state laws are preempted), and several legislative leaders (who have intervened as defendants in the case and argue that the state laws are not preempted) have all appealed the district court’s judgment to the U.S. Court of Appeals for the Fourth Circuit.

This case could affect access to mifepristone by deciding whether states may impose burdensome restrictions on mifepristone beyond FDA’s regulations, including those barring administration via telehealth or otherwise making mifepristone more difficult to access.

 

The case is currently pending before the U.S. Court of Appeals for the Fourth Circuit. 

The parties have filed briefs, but the case is temporarily suspended pending a decision by the U.S. Court of Appeals for the Fourth Circuit in GenBioPro, Inc. v. Raynes (Case No. 23-2194) (see above). Although GenBioPro, Inc. v. Raynes is now closed (see above), this case currently remains pending.

Purcell et al. v. Kennedy et al.,
Case No. 1:17-00493

U.S. District Court for the District of Hawaii

October 13, 2017

Hawaii

Plaintiffs—a health care provider, Society of Family Planning, and the California Academy of Family Physicians—challenge FDA’s current set of restrictions (the Risk Evaluation and Mitigation Strategy (REMS)) on mifepristone as unduly burdensome and arbitrarily restrictive given mifepristone’s safety and effectiveness.  Plaintiffs argue that these restrictions—which require patients to certify they have decided to take mifepristone to end their pregnancy and limit who can prescribe and dispense the drug by requiring providers and pharmacies to undergo a special certification process—delay care, deter qualified providers and pharmacies from prescribing and dispensing mifepristone because of the burdens related to certification, and impede research and training on mifepristone at academic institutions.

Plaintiffs assert claims under the equal protection guarantee of the Fifth Amendment and the Administrative Procedure Act, alleging they are treated differently from other similarly situated parties without a sufficient state interest, and that FDA’s imposition of the REMS was not based on a reasoned decision or rational basis.

The case could affect access by eliminating or leaving intact current restrictions on mifepristone that impede access by limiting the health care professionals who can prescribe it and the pharmacies that can dispense it.  The case could also determine whether FDA may continue to require the patient agreement form, which plaintiffs assert presents privacy risks for patients and providers.

On October 30, 2025, the court granted plaintiffs’ motion for summary judgement and denied defendant’s cross-motion. The court ruled that the FDA acted arbitrarily and capriciously in violation of the Administrative Procedure Act because it failed to consider relevant evidence and failed to provide adequate reasoning as to why it was restricting mifepristone access. The matter was remanded to the Agency to reassess the REMS in accordance with the court's order and the law. Plaintiffs’ constitutional claims remain pending. 

Washington et al. v. U.S. Food and Drug Administration et al.,
Case No. 1:23-cv-03026

(Final judgment entered—case closed.) 

U.S. District Court for the Eastern District of Washington

February 23, 2023

Washington

17 states and Washington, D.C. (the States) challenge FDA’s mifepristone REMS as unduly burdensome and arbitrarily restrictive given mifepristone’s safety and effectiveness.  The States argue that these restrictions—which require patients to certify they have decided to take mifepristone to end their pregnancy and limit who can prescribe and dispense the drug by requiring providers and pharmacies to undergo a special certification process—are unnecessary barriers that make it more difficult to access care.  

The States argue that FDA violated the Administrative Procedure Act by imposing the REMS against evidence showing the restrictions are unnecessary, and violated the equal protection guarantee of the Fifth Amendment by treating providers, pharmacists, and patients who prescribe, dispense, or use mifepristone worse than those who prescribe, dispense, or use other medications.

The case affects access by leaving intact current restrictions on mifepristone that impede access by limiting the health care professionals who can prescribe it and the pharmacies that can dispense it.  FDA may continue to require the patient agreement form, which the States assert presents privacy risks for patients and providers.    

On July 8, 2025, the court issued a final decision granting defendant’s cross-motion for summary judgment and dismissing the case.   

Based on the record before it, the court found that FDA’s review and decision regarding the mifepristone REMS was reasonable, not arbitrary or capricious, and did not ignore any laws or regulations. The court’s decision did not reach plaintiffs' equal protection claim.   

Final judgment was entered—this case is now closed.

GenBioPro v. U.S. Food and Drug Administration, et al.,
Case No. 8:23-cv-01057

(Voluntarily dismissed—case closed.) 

U.S. District Court for Maryland

April 19, 2023

Maryland

GenBioPro, a manufacturer of generic mifepristone, filed suit in April 2023 to prevent other federal court rulings (including those issued by the district court and Fifth Circuit in Alliance for Hippocratic Medicine v. FDA) from stripping FDA approval of generic mifepristone without following the required statutory and regulatory procedures for suspension of a drug’s approval.

GenBioPro argues that suspending approval of mifepristone without proper process would violate the Administrative Procedure Act, the All Writs Act, and the due process guarantee of the Fifth Amendment.  GenBioPro asserts that any enforcement action characterizing its mifepristone as misbranded and without an effective drug approval based on federal court rulings that did not provide a constitutionally adequate procedure for suspending drug approval would be unlawful.

The case could have affected access to mifepristone by determining whether court decisions may suspend its approval.   

This case was originally stayed while the Supreme Court resolved Alliance for Hippocratic Medicine v. FDA. It was further stayed in light of a pending decision in   Missouri v. FDA, Case No. 2:22-cv-00223, on motions to dismiss the case.

On November 14, 2025 GenBioPro voluntarily dismissed of the case without prejudice. The court dismissed the case without prejudice on November 17, 2025. 

Whole Woman’s Health Alliance et al. v. U.S. Food and Drug Administration et al.,
Case No. 3:23-cv-00019

U.S. District Court for the Western District of Virginia

May 8, 2023

Virginia

Abortion providers in Virginia, Montana, and Kansas challenge FDA’s current mifepristone REMS as unduly burdensome and arbitrarily restrictive given mifepristone’s safety and effectiveness.  The providers argue that these restrictions—which require patients to certify they have decided to take mifepristone to end their pregnancy and limit who can prescribe and dispense the drug by requiring providers and pharmacies to undergo a special certification process—are unnecessary barriers that make it more difficult to access care. 

Plaintiffs argue that FDA violated the Administrative Procedure Act by imposing the REMS against evidence showing the restrictions are unnecessary, and violated the equal protection guarantee of the Fifth Amendment by treating providers, pharmacists, and patients who prescribe, dispense, or use mifepristone worse than those who prescribe, dispense, or use other medications.

The case could affect access by eliminating or leaving intact current restrictions on mifepristone that impede access by limiting the health care professionals who can prescribe it and the pharmacies that can dispense it.  The case could also determine whether FDA may continue to require the patient agreement form, which plaintiffs assert presents privacy risks for patients and providers.    

The case is currently pending in federal district court in Virginia. 

In October 2024, plaintiffs filed a motion for summary judgment.  In December 2024, defendants filed a cross-motion for summary judgment, arguing that plaintiffs’ claims should be dismissed on the merits, and that plaintiffs lack standing and did not administratively exhaust their claims by first raising them with FDA.

The court held oral argument on the motions for summary judgment on May 19, 2025.  The court has not yet issued a decision.

Missouri et al. v. U.S. Food and Drug Administration et al.,  

 Case No. 4:25-cv-01580 

U.S. District Court of Eastern District of Missouri  

(Transferred from U.S. District Court for the Northern District of Texas) 

November 18, 2022

Texas

Missouri, Kansas, and Idaho (the States) seek to revive a prior case, Alliance for Hippocratic Medicine, et al., v. FDA, in which the States had intervened.  In June 2024, the Supreme Court held that the plaintiffs in AHM v. FDA—anti-abortion doctors and activists who never prescribed and never experienced harm related to mifepristone—lacked standing, and all claims in AHM v. FDA were dismissed.  In October 2024, the States filed an amended complaint in the same federal district court in Texas that presided over AHM v. FDA. 

The States claim FDA decisions in 2016, 2021, and 2023 relaxing prior restrictions on mifepristone and FDA’s 2019 approval of the generic form of the drug were not supported by adequate evidence and as a result violate the Administrative Procedure Act.  The States seek to rescind the 2019 generic approval and reimpose restrictions on mifepristone that FDA has determined are medically unnecessary, including the pre-2021 requirement that it be dispensed in-person, and the pre-2016 restrictions requiring three office visits, limiting prescription of mifepristone to only certified physicians, indicating it could only be used for pregnancies up to 7 weeks (rather than 10 weeks), and requiring the reporting of all serious non-fatal adverse events to FDA.  The States also seek an order prohibiting provision of mifepristone to adolescents.

This case could affect access to mifepristone by imposing burdensome restrictions on mifepristone FDA has determined are medically unnecessary, including requirements for in-person dispensing and office visits (which would prohibit mifepristone’s administration via telehealth) and limitations on which health care providers can prescribe mifepristone.  The case could also affect adolescent access to mifepristone. 

On August 22, 2025, Texas and Florida moved to intervene and  on September 19, 2025, the state of Louisiana and an individual resident moved to intervene.

On September 30, 2025, Judge Kacsmaryk granted defendant’s motion to dismiss for lack of venue and transferred the case to the Eastern District of Missouri.  

On October 23, 2025, the case was transferred and assigned to Judge Cristian M. Stevens. 

Birthmark Doula Collective v. State of Louisiana,
Case No. C-7552171

Louisiana State Trial Court (19th Judicial District Court)

October 31, 2024

Louisiana

Plaintiffs—birth workers and other medical professionals, advocates, and a pregnant person—challenge a Louisiana law classifying mifepristone and misoprostol, safe medications with no risk of abuse or dependence, as controlled dangerous substances. Plaintiffs argue that this classification delays access to the medication, risking the health and safety of patients, including those carrying pregnancy to term and experiencing miscarriages. Plaintiffs assert that the law discriminates based on physical condition thereby violating Louisiana’s constitutional right to equal protection. Plaintiffs also argue that the legislature violated state constitutional requirements (the single object requirement and germane amendment rule) in amending a bill introduced to create the crime of coerced abortion to add the unrelated matter of classifying mifepristone and misoprostol as controlled substances.

This case could impact emergency care for pregnant people in Louisiana. Classification of mifepristone and misoprostol as controlled dangerous substances delays access to care, posing a particular threat to the health and safety of people experiencing obstetric emergencies.

The case is currently pending in Louisiana trial court. On May 15, 2025, the court held a hearing on defendants’ motion requesting dismissal of the case and ruled on June 10, 2025 that plaintiffs’ challenge can proceed.  

The Mifepristone Federal Action Tracker

The Mifepristone Federal Action Tracker covers federal actions since January 1, 2025, and was last updated in December 2025. Download a PDF version here.

Date

Summary of Action

What’s at Stake

Current Status

December 9, 2025

 

 

 

Bloomberg reported according to key sources that FDA has postponed reviewing the safety of mifepristone until after the 2026 midterm elections at FDA administrator Martin A. Makary’s request.

 

 

 

The reporting suggests FDA’s process lacks transparency and is driven by politics rather than science. The public should have information on governmental action that could affect access to abortion.

 

  

U.S. Health Secretary Robert F. Kennedy Jr. and Martin A. Makary stated in September 2025 that FDA review of the safety of mifepristone was ongoing. On December 10, 2025, Senator Josh Hawley sent a letter to Martin A. Makary seeking the prompt review of mifepristone in light of the reports that review will be delayed until after the 2026 midterms.

September 30, 2025 

FDA approved a new generic mifepristone by Evita Solutions, LLC. It may be used up to 70 days after the last menstrual period to terminate early pregnancy. 

The approval may increase supply of and access to mifepristone in the country, despite a recent announcement by U.S. Health Secretary Robert F. Kennedy Jr. and FDA administrator Martin A. Makary that the agency is reviewing the safety of mifepristone.  

Senator Josh Hawley wrote a letter to FDA commissioner Martin A. Makary expressing his concern for the recent mifepristone approval and asking for an explanation for the decision to approve the medication. 

September 19, 2025 

U.S. Health Secretary Robert F. Kennedy Jr. and FDA administrator Martin A. Makary announced that the FDA is conducting a review of mifepristone

If FDA were to change or roll back mifepristone approval, many individuals may be unable to access the drug or find it even more challenging to access, especially in areas that already have a dearth in access to reproductive health resources. 

The letter indicated that review of mifepristone is ongoing. 

August 13, 2025 

The American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) resubmits a Citizen Petition that was previously denied to request that the FDA deny approval of mifepristone for miscarriage management. AAPLOG previously submitted a similar Petition in January 2025, which was denied by FDA in June 2025. 

Currently, mifepristone is commonly prescribed off-label for miscarriage management.  In all areas of medicine, “off-label” use of medications to reflect evolutions in evidence-based practice is permissible, common, and necessary to ensure that clinical care is not undermined by scientifically outdated labeling.  Imposition of stricter restrictions than currently exist for mifepristone’s use to treat miscarriages—as requested by this petition—would unnecessarily limit access and burden providers and patients. 

FDA acknowledged receipt of the petition on August 21, 2025. FDA must respond to the petition within 180 days by granting or denying the request, or saying it needs more time to respond. 
August 20, 2025   Sixteen states and Washington D.C. (“Petitioner States”) filed a Citizen Petition to join the “Multistate Citizen Petition” that California, Massachusetts, New York, and New Jersey filed in June 2025.    This petition seeks to ensure access to mifepristone generally and increase access in the Petitioner States. In addition to joining the Multistate Citizen Petition (see June 5th filing detailed below), the Petitioner States request that FDA remove the Mifepristone REMS Program or choose not to enforce the Mifepristone REMS Program in the Petitioner States. The Petitioner States also submit additional evidence in support of this Petition that illustrates the importance of medication abortion in their states and the negative impact restrictions would have. FDA acknowledged receipt of the petition on August 21, 2025. FDA must respond to the petition within 180 days by granting or denying the request, or saying it needs more time to respond. 

July 3, 2025 

GenBioPro files a Citizen Petition to request that absent new peer-reviewed studies or robust scientific evidence, FDA take no action that would restrict patient access to mifepristone or increase the burdens associated with prescribing or dispensing mifepristone. Additionally, GenBioPro requests that any change meet all rules and procedures afforded by law and regulation and that FDA will permit GenBioPro to continue to distribute and ship mifepristone until such procedures have been completed.   

This petition seeks to ensure FDA does not act without adhering to its rules and procedures, and only acts in reliance on robust scientific or clinical evidence. If FDA takes action to restrict, modify, or withdraw approval of mifepristone, in the absence of robust scientific or clinical evidence for doing so, it would create unnecessary burdens on patients who rely on the ability to access safe and effective medication through telehealth. Patients in rural or remote areas may be especially impacted, along with those who are unable to travel long distances to acquire the medication because of work or child care needs.   

FDA acknowledged receipt of the petition on July 7, 2025. FDA must respond to the petition within 180 days by granting or denying the request, or saying it needs more time to respond. 

June 5, 2025

California, Massachusetts, New York, and New Jersey file a Citizen Petition requesting FDA eliminate the current REMS for mifepristone or in the alternative, cease enforcing the restrictions as unnecessary.

According to a representative of the states, in response to the filing of this petition, FDA will need to consider the ample scientific research of mifepristone’s safety and effectiveness, including newer research, and it cannot change its current regulation of mifepristone while the petition is pending.

In response to the petition, FDA may decide to eliminate or leave intact current restrictions on mifepristone that impede access by limiting the health care professionals who can prescribe it and the pharmacies that can dispense it.  FDA may also determine whether to continue to require the patient agreement form.

FDA acknowledged receipt of the petition on June 6, 2025.  FDA must respond to the petition within 180 days by granting or denying the request, or saying it needs more time to respond.

On August 20, 2025, Arizona, Colorado, Connecticut, Delaware, Hawai’i, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Washington, the District of Columbia, and Josh Shapiro in his official capacity as Governor of the Commonwealth of Pennsylvania filed a petition to join the multistate citizen petition and submit additional evidence in support of it.  

On November 25, FDA issued an interim response letter stating that given the complexity of the request, a decision had not yet been reached. 

May 14, 2025

U.S. Health Secretary Robert F. Kennedy Jr. testifies before the Senate Health, Education, Labor and Pensions Committee that he has ordered FDA administrator Martin A. Makary to conduct a “complete review” of mifepristone regulations.

In response to a question from Senator Hawley, Kennedy agreed that FDA review of mifepristone is necessary in part because of a recent report on mifepristone released by anti-abortion activists that was not peer-reviewed or published in a medical journal.  (Hearing on Fiscal Year 2026 Department of Health and Human Services Budget, May 14, 2025, 1:48:15-1:50:40)  In contrast, more than one hundred scientific studies conducted over the last 30 years have conclusively proven mifepristone’s safety.

 

If FDA were to impose additional restrictions on mifepristone, whether reimposing prior restrictions or creating new ones, it could decrease access throughout the country, including in states where abortion is legal.

Kennedy indicated FDA review of mifepristone is ongoing.  (Hearing on Fiscal Year 2026 Department of Health and Human Services Budget, May 14, 2025, 1:48:15-1:50:40)

The timeline and parameters of FDA’s review of mifepristone are unclear.  CRR and ACLU have filed lawsuits to enforce FDA’s obligation under the Freedom of Information Act to produce information about its review of and communications related to mifepristone. 

May 12, 2025

An individual, James Brinkruff, files a Citizen Petition requesting immediate suspension of the approval of mifepristone for medication abortion, an FDA study of mifepristone when used via telehealth, and imposition of requirements for in-person dispensing and a follow-up appointment.  

If FDA were to suspend approval of mifepristone for medication abortion, it would severely affect access to abortion throughout the country—medication abortion is currently used in nearly two-thirds of all abortions in the United States.  Imposing additional restrictions on mifepristone would also decrease access throughout the country, including in states where abortion is legal.

FDA acknowledged receipt of the petition on May 14, 2025.  FDA must respond to the petition within 180 days by granting or denying the request, or saying it needs more time to respond.

On November 7, 2025, FDA issued an interim response letter stating that given the complexity of the request, a decision had not yet been reached. 

March 6, 2025

Dr. Marty Makary (then-nominee, now head of the FDA), states during his confirmation hearing that he would review whether FDA should re-impose an in-person dispensing requirement for mifepristone.

FDA’s imposition of an in-person dispensing requirement for mifepristone would significantly decrease access, particularly for rural and underserved communities, and those who can’t travel or take time away from work. 

Kennedy has since indicated that FDA review of mifepristone is ongoing.  (Hearing on Fiscal Year 2026 Department of Health and Human Services Budget, May 14, 2025, 1:48:15-1:50:40) 

January 31, 2025

The American College of Obstetricians and Gynecologists, Society of Family Planning, and Society for Maternal-Fetal Medicine submit a Citizen Petition requesting FDA eliminate the current REMS for mifepristone or in the alternative refrain from taking any action that would further reduce patient access to mifepristone or increase the burdens associated with prescribing or dispensing mifepristone.

FDA may decide to eliminate or leave intact current restrictions on mifepristone that impede access by limiting the health care professionals who can prescribe it and the pharmacies that can dispense it.  FDA may also determine whether to continue to require the patient agreement form.  

FDA acknowledged receipt of the petition on February 4, 2025.  FDA must respond to the petition within 180 days by granting or denying the request, or saying it needs more time to respond. On July 28, 2025, FDA issued an interim response letter stating that given the complexity of the request, a decision had not yet been reached.  

 

January 29, 2025

Robert F. Kennedy Jr. (then-nominee, now Secretary of Health) states during his confirmation hearing: “President Trump has asked me to study the safety of mifepristone. He has not yet taken a stand on how to regulate it. Whatever he does, I will implement those policies.”

If FDA were to impose additional restrictions on mifepristone, whether reimposing prior restrictions or creating new ones, it could decrease access throughout the country, including in states where abortion is legal.

Kennedy has since indicated that FDA review of mifepristone is ongoing.  (Hearing on Fiscal Year 2026 Department of Health and Human Services Budget, May 14, 2025, 1:48:15-1:50:40) 

January 7, 2025

American Association of Pro-Life Obstetricians and Gynecologists submit a Citizen Petition noting that there had been news reports that mifepristone’s manufacturer had planned to apply to add miscarriage management as an indication for mifepristone, and requesting that if FDA approve that indication it establish a REMS prohibiting telehealth, requiring an in-person follow-up appointment with an ultrasound, and requiring reporting of all adverse events.

Students for Life of America had also filed a Citizen Petition in December 2024, requesting that FDA refrain from modifying the approved usage of mifepristone to include miscarriage care.

Currently, mifepristone is commonly prescribed off-label for miscarriage management.  In all areas of medicine, “off-label” use of medications to reflect evolutions in evidence-based practice is permissible, common, and necessary to ensure that clinical care is not undermined by scientifically outdated labeling.  Imposition of stricter restrictions than currently exist for mifepristone’s use to treat miscarriages—as requested by this petition—would unnecessarily limit access and burden providers and patients.

On June 4, 2025, FDA denied the petition filed by American Association of Pro-Life Obstetricians and Gynecologists, stating that to the extent there is any pending application to add miscarriage management as an approved indication for mifepristone, FDA had not issued a final determination to approve it and consideration of the issues presented in the petition outside FDA’s approval process would be procedurally improper.  

Citing the same reasons, FDA denied the petition filed by Students for Life of America on May 21, 2025.
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