The US Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization — which overturned Roe v. Wade and nearly 50 years of a federal constitutional right to abortion — has had a tectonic impact. Less than a year later, on April 7, 2023, one of the most consequential aftershocks of the Dobbs decision emerged. In Alliance for Hippocratic Medicine v. US Food and Drug Administration, Judge Kacsmaryk of the US District Court for the Northern District of Texas, Amarillo division, issued a nationwide retroactive stay of the FDA’s approval of mifepristone,1 one of two medications in a two-drug, mifepristone-misoprostol treatment regimen2 that has been the only FDA-approved medication abortion option in the United States since its approval more than 20 years ago.
The majority of abortions in the United States are managed through medication abortion rather than procedural abortion,3 and access to medication abortion has become increasingly important as many states have adopted laws restricting abortion services in the wake of the Dobbs decision. In a 67-page opinion, Judge Kacsmaryk concluded, among other things, that the FDA exceeded its authority by initially approving mifepristone in 2000 under its Subpart H regulations and “acquiesced on legitimate safety concerns” in doing so; violated another federal law by allowing mifepristone to be dispensed via mail during the COVID-19 pandemic; and has “stonewalled” timely judicial review of its regulatory decisions related to mifepristone.
Shortly after Judge Kacsmaryk’s decision, on the same day, Judge Thomas O. Rice of the US District Court for the Eastern District of Washington issued a contrasting decision in a second lawsuit, Washington vs. US Food and Drug Administration. In that case, several states’ attorneys general sought to remove the FDA’s regulatory restrictions on access to mifepristone and to enjoin the FDA from taking any action to remove mifepristone from the market or reduce its availability. Judge Rice’s ruling granted the plaintiffs’ requests in part and preliminarily enjoined the FDA from “altering the status quo and rights as it relates to the availability of mifepristone” in the 17 plaintiff states4 and the District of Columbia. Judge Rice declined the plaintiffs’ request for a nationwide injunction.
In the near-term, litigation in Alliance for Hippocratic Medicine is continuing. Judge Kacsmaryk stayed his ruling for seven days to give the Department of Justice the opportunity to seek emergency relief before the US Court of Appeals for the Fifth Circuit, and the Department of Justice filed a notice of appeal that same evening.5 The United States will also seek a stay of Judge Kacsmaryk’s order pending the outcome of the proceedings in the Fifth Circuit—or, given the contradictory rulings between the Texas and Washington cases, the United States may immediately seek review in the US Supreme Court. If Judge Kacsmaryk’s decision is stayed pending appeal, the impact of his order on the availability of mifepristone would not be felt in the near-term. Ultimately, Alliance for Hippocratic Medicine v. FDA, on its own or together with Washington v. FDA, may need to be heard and resolved by the Supreme Court; however, whether that may occur sooner or after further proceedings in the Fifth Circuit and Ninth Circuit is not yet known.
Although the final outcome of these proceedings remains to be determined, it is difficult to overstate the unprecedented and potentially far-reaching impact of the ruling in Alliance for Hippocratic Medicine. If allowed to stand, a decision in one state’s federal district court would undermine access to mifepristone nationwide because FDA approval of the drug is the basis for the drug’s manufacturing, marketing, and distribution throughout the United States. Thus, even in those states that do not have restrictive abortion laws, an abortion medication that has been a mainstay of evidence-based care for over 20 years would no longer be available. This would lead to tremendous disruption for people needing abortion care and their healthcare providers.
In addition, Judge Kacsmaryk’s ruling raises urgent and vital questions about the stability and integrity of the FDA’s drug approval process. It is wholly uncharted territory for a coalition of physicians and physician groups to seek and obtain judicial relief to stay an FDA approval. Although the plaintiffs’ case and the judge’s decision here focused on specific aspects of the FDA’s approval and regulatory oversight for mifepristone, this decision could become a stepping stone and playbook for others to come forward to challenge the FDA approvals of other drugs. The prospect that a single judge could sweep away a long-standing FDA approval decision represents an enormous new source of uncertainty for patients, healthcare professionals, the FDA, biopharmaceutical companies, investors, and other stakeholders who rely on a predictable, science-based regulatory process for essential medicines. Indeed, hundreds of CEOs and other leaders in the biopharmaceutical industry issued on April 10, 2023 an open letter opposing “Judge Kacsmaryk’s act of judicial interference,” standing together to “unequivocally support the continued authority of the FDA to regulate new medicines,” and calling for reversal of the decision.
Goodwin’s Dobbs Task Force is closely following both of these cases, other litigation and enforcement developments following the Dobbs decision, and the wide-ranging implications of shifting access to reproductive healthcare for patients, their families, providers, employers, governments, life sciences companies, and other stakeholders. Please contact your Goodwin lawyer or the Task Force members listed below with any questions or inquiries related to these timely and important issues and how this litigation may impact you or your organization.
Overview of Alliance for Hippocratic Medicine v. FDA
On November 18, 2022, a group of medical organizations and doctors, led by the Alliance for Hippocratic Medicine and supported by the Alliance Defending Freedom, filed a complaint before Judge Kacsmaryk in the US District Court for the Northern District of Texas, seeking a preliminary and permanent injunction to withdraw the FDA’s approval of the mifepristone-misoprostol medication abortion regimen, and to hold unlawful and set aside numerous regulatory decisions the FDA made with respect to the regimen in subsequent years.6 The plaintiffs alleged that the FDA’s actions violated the Administrative Procedure Act because the Agency’s initial approval of the mifepristone-misoprostol regimen in 2000 was granted under an improper regulatory pathway, that the FDA’s subsequent regulatory decisions (including decisions to revise the Risk Evaluation and Mitigation Strategy, or REMS,7 for mifepristone) were not based on appropriate information and data, that the regimen is not safe, and that the FDA’s decision to allow abortion medications to be sent via mail violated federal laws.
In its January 13, 2023 response, the Department of Justice (litigating on behalf of the FDA) urged the court to dismiss the case because the plaintiffs lack standing, the claims are untimely because they were brought after the six-year statute of limitations to challenge an Agency action, the FDA’s regulatory actions were proper and within its statutory authority, and a preliminary injunction is inappropriate because the required showing for “imminent and irreparable harm” is not appropriate when the drug has been on the market for decades. The government asserted that a preliminary injunction would in fact harm the public interest by removing a medication abortion regimen that is safe and effective and that patients and doctors have relied upon for many years. The government also stated that the federal mail laws cited by plaintiffs, as interpreted by federal courts, do not prohibit the mailing of contraceptives or abortion medications as long as the sender does not intend for the items to be used unlawfully.
Danco Laboratories, the manufacturer of Mifeprex, the branded version of mifepristone,8 intervened in the case to oppose the plaintiffs’ motion for a preliminary injunction. Danco underscored many of the government’s arguments, affirming the safety, efficacy, and proper FDA approval and regulation of mifepristone, and added that, because it is a small pharmaceutical company whose sole product is Mifeprex, a preliminary injunction would have “existential” consequences. Danco also highlighted that the Government Accountability Office was asked by Congress on two occasions (once in 2008 and 2018) to review the FDA’s approval and regulatory oversight of Mifeprex, and concluded on both occasions that the FDA’s regulatory decisions were appropriate and consistent with the Agency’s approval and oversight of similarly situated drugs.
Reflecting the high stakes and intense public interest in this case, numerous parties submitted amicus briefs to the docket:
- Twenty-two states9 filed a brief supporting the plaintiffs’ motion for a preliminary injunction, stating among other things that the FDA’s regulatory actions undermine states’ authority to protect the health, safety, and welfare of their citizens and force states to divert their scarce resources to investigate and prosecute violations of their laws. The State of Missouri submitted its own brief supporting the plaintiffs’ motion for a preliminary injunction, sharing perspectives about abortion practices in the state that were uncovered in litigation.
- Other amici curiae that filed briefs supporting the plaintiffs’ motion for a preliminary injunction included the Charlotte Lozier Institute; American Center for Law and Justice; Human Coalition; Family Research Council; Susan B. Anthony Pro-Life America and the Catholic Health Care Leadership Alliance, National Catholic Bioethics Center, Catholic Bar Association, Catholic Benefits Association, and Christ Medicus Foundation; and the Chattanooga National Memorial for the Unborn. These amici offered a range of perspectives, including concerns about the safety of medication abortion and undue political influence on the FDA’s approval of mifepristone.
- Twenty-one states10 and the District of Columbia filed a brief supporting the defendants and opposing the motion for a preliminary injunction, asserting that states have a strong interest in protecting their residents’ ability to obtain abortion care, that medication abortion is safe and effective and has helped promote access to abortion in rural and underserved communities, and that annulling the approval of mifepristone would have “devastating” consequences for individuals seeking abortion and strain healthcare system resources.
- The American College of Obstetricians and Gynecologists, the American Medical Association, the Society for Maternal-Fetal Medicine, the American Society for Reproductive Medicine, and other medical and public health societies filed a brief supporting the defendants and opposing the motion for a preliminary injunction, stating that “the scientific evidence supporting mifepristone’s safety and efficacy is overwhelming”, that their ability to safely and effectively care for patients requires access to mifepristone, and that overturning the approval of mifepristone will impose significant burdens on physicians and hospitals. Doctors for America submitted its own brief stating that an injunction on mifepristone would disrupt medical practice nationwide, including for conditions beyond abortion such as management of early pregnancy loss.
- Nineteen food and drug law scholars filed a brief urging the court to deny the plaintiffs’ request, asserting that the plaintiffs “gravely mischaracterized” US federal food and drug law, that the FDA’s approval and regulation of mifepristone has been consistent with its statutory authorities and regulatory standards, and that granting a preliminary injunction would undermine the established statutory and regulatory drug approval process more broadly beyond mifepristone, with far-reaching consequences for patients, healthcare providers, and the biopharmaceutical industry.
On March 15, 2023, Judge Kacsmaryk held a four-hour hearing to hear arguments from the plaintiffs and the defendants before issuing his opinion on April 7, 2023.
What Comes Next & Implications To Watch
Although Judge Kacsmaryk’s decision to stay the approval of mifepristone could, if upheld, be an enormous setback for the availability of this important medication, the April 7, 2023 decision is not the final word on the matter. The United States has already filed a notice of appeal and will seek a stay of Judge Kacsmaryk’s order pending appeal. Given the existence of two plainly contradictory opinions — one that requires a nationwide suspension of mifepristone and another that enjoins the FDA from altering the availability of mifepristone in 17 states plus the District of Columbia — the United States may try to seek immediate review before the Supreme Court. In either event, litigation over this matter will likely continue for quite some time.
Until the FDA’s approval of mifepristone is in fact stayed or withdrawn, the manufacturing and distribution of mifepristone will continue to be legal under federal law, and providers and patients can continue to access it in those states where it is legal to do so. However, given the uncertainty spawned by this decision and the potential threat of disrupted access to mifepristone if Judge Kacsmaryk’s decision is ultimately upheld (or if his decision is not stayed), healthcare providers and patients may begin to seek alternatives. An increasing number of people seeking mifepristone may turn to overseas sources, which do not have the same safeguards as those for drugs manufactured and distributed in the United States under FDA oversight. Healthcare providers have begun publishing and adopting evidence-based, misoprostol-only protocols for medical abortion that can be used safely for certain patients in lieu of the misoprostol-mifepristone regimen. These misoprostol-only protocols can, however, be more uncomfortable for the patient and have a lower effectiveness rate than the mifepristone-misoprostol regimen.11 Patients and healthcare providers may opt for procedural abortions more often in states where those procedures are still available; however, the accessibility of procedural abortion has declined since the Dobbs decision, even in states where it remains legal. Therefore, even if there may be alternatives in the event mifepristone becomes unavailable, its removal would be extremely disruptive as medical care patterns transition, and this disruption would greatly diminish access to abortion care and impose additional costs, treatment-related burdens, and stigma for patients and healthcare providers.
In addition to the significant potential consequences of this decision for medication abortion, the implications of Judge Kacsmaryk’s decision extend even further. The decision throws multiple grenades at key elements of the FDA’s regulatory process and authority — including the Agency’s selection of regulatory pathways for approval, its approval of supplemental applications, and its exercise of enforcement discretion — and challenges the FDA’s judgment with respect to drug safety. This ruling must be a wake-up call for the biopharmaceutical and healthcare sectors. The ability of patients, healthcare providers, and industry to rely, generally, on the FDA’s decisions and a stable, scientifically-grounded regulatory process is foundational to the vibrant system of drug development and innovation in the United States, and to the range of treatment options available to patients and healthcare providers. Historically, courts have granted the FDA’s decisions substantial deference, recognizing the Agency’s extensive clinical and scientific expertise and the difficult and highly contextualized benefit-risk judgments that the FDA makes when approving and regulating medical products. The prospect that a judge could stay or invalidate a drug’s approval — even decades after it has been granted, and outside the purview of the FDA’s established administrative process—represents a bracing new source of uncertainty and risk for biopharmaceutical companies marketing products in the United States.
At a minimum, Judge Kacsmaryk’s order could embolden already-vocal opponents of certain types of therapies (contraceptives, fertility medications, drugs used for gender affirming therapy, HIV prophylaxis medications, vaccines, and mRNA-based medicines, to name a few) to pursue approval-nullifying claims in federal courts where sympathetic judges preside. Any lawsuit that questions the legitimacy of a drug’s FDA approval can be extremely harmful, not only because of the cost and attention required to defend the case but also because of the unwelcome attention, scrutiny, and misconceptions that these lawsuits may generate.
The two April 7, 2023 decisions in Alliance for Hippocratic Medicine v. FDA and Washington v. FDA have set the stage for a legal clash with the highest stakes for an essential drug in reproductive care and the stability and integrity of the FDA’s regulatory oversight. We will continue to provide updates as these legal proceedings unfold.
The FDA approval of mifepristone is not stayed immediately, as Judge Kacsmaryk stayed the applicability of his order for seven days to give the Department of Justice the opportunity to seek emergency relief before the US Court of Appeals for the Fifth Circuit.
This medication abortion treatment regimen involves the sequential administration of two drugs (mifepristone on Day 1, followed by misoprostol 24 to 28 hours later). It is FDA-approved for the termination of an intrauterine pregnancy through 70 days’ gestation.
A medication abortion uses medicine to end a pregnancy. The medication helps to end the pregnancy and prompt the body’s ejection of tissue from the uterus. The alternative to a medication abortion is a procedural abortion (also referred to as a surgical abortion), in which a healthcare provider uses an instrument or suction to remove tissue from the uterus.
Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, and Pennsylvania.
Danco Laboratories, the manufacturer of Mifeprex, the branded version of mifepristone, joined the Alliance for Hippocratic Medicine case as an intervenor-defendant and is joining the appeal.
The Alliance for Hippocratic Medicine was incorporated in Amarillo, Texas in August 2022. Judge Kacsmaryk, the only federal judge in the Northern District of Texas’s Amarillo division, was appointed to the court in 2019.
The Risk Evaluation and Mitigation Strategy (REMS) for mifepristone currently requires that health care providers must be certified under the Mifepristone REMS program to prescribe the regimen, that patients must review with their health care provider and sign a Patient Agreement Form, and that the product must be dispensed by a certified prescriber or a certified pharmacy that has completed a Pharmacy Agreement Form. When mifepristone was initially approved in 2000, the elements of the REMS were more stringent, and the FDA modified these elements over time.
The other manufacturer of mifepristone is GenBioPro, which markets a generic version of Mifeprex.
Mississippi, Alabama, Alaska, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Montana, Nebraska, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, and Wyoming.
New York, California, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, North Carolina, Oregon, Pennsylvania, Rhode Island, Washington, and Wisconsin.
 This misoprostol-only regimen is widely used internationally and recommended by the World Health Organization as a method of medication abortion care when mifepristone is not available.
Jaime A. SantosPartner
Caroline H. Bullerjahn and Elaine Herrmann Blais co-chair the Goodwin Dobbs Task Force.
Caroline H. BullerjahnPartner
Elaine Herrmann BlaisPartner