Julia Kaye

On May 27, 2020, Julia Kaye led a challenge to a visit the FDA required even after a clinician had decided that a patient could receive mifepristone. In American College of Obstetricians and Gynecologists v. FDA, the ACLU and Arnold & Porter sought to suspend two requirements during the COVID-19 emergency: collecting the medicine at a health-care facility and signing the Patient Agreement there.

The regimen described in the case began with one 200-milligram tablet of mifepristone, followed by misoprostol twenty-four to forty-eight hours later. A patient could take both medicines at home. Before prescribing, a clinician assessed pregnancy duration and the risk of an ectopic pregnancy, discussed alternatives and possible complications, and obtained informed consent. When medical judgment permitted that assessment by telemedicine, the patient could complete it without entering a hospital, clinic, or medical office. FDA nevertheless required a trip to one of those facilities for the mifepristone and the signature.

Kaye questioned why the package had to change hands there. In her account of the lawsuit that May, she argued that mifepristone was unique among more than 20,000 FDA-regulated drug products: patients had to collect it in a clinical setting but could use it without clinical supervision. Misoprostol, its companion in the regimen, could already be obtained from an ordinary pharmacy.

Both early medication abortion and miscarriage management were time-sensitive. For a patient already assessed and counseled, the additional visit could require transportation, childcare and time away from work without adding an examination or treatment. During the pandemic, reduced clinic capacity and exposure to the virus increased the cost of that requirement.

What Delivery Would Leave in Place

The FDA regulated mifepristone through a Risk Evaluation and Mitigation Strategy, or REMS. Three requirements shaped the case: prescribers had to certify their qualifications, dispensing had to occur in a specified health-care setting, and a signed Patient Agreement had to document counseling and receipt of information. The dispensing rule barred provider shipment, mail-order filling and retail-pharmacy dispensing even where state law permitted remote care.

Kaye’s coalition proposed delivery within the existing prescription system. Certified clinicians would still need the ability to date a pregnancy and diagnose an ectopic pregnancy, provide or arrange surgical intervention when necessary, and ensure access to emergency care. They would explain the regimen, risks and alternatives, give instructions for complications and follow-up, and obtain informed consent.

The Patient Agreement presented a separate obstacle because its signature language contemplated the patient signing in the prescriber’s presence. The proposed alternative preserved the review and questions through telemedicine, with a signature returned electronically or by mail. The provider would supply the signed agreement and Medication Guide and retain the required copy. Distribution would still run through certified providers, who arranged delivery to named patients and recorded package serial numbers; the drug would not move onto retail shelves.

FDA defended facility dispensing as an opportunity for counseling and a protection against late receipt, ineffective timing or difficulty finding a pharmacy that stocked the medicine. Government lawyers urged deference to the agency’s expertise. Kaye’s clients challenged the continuing value of those reasons: the agency’s last complete justification preceded widespread telemedicine and its own 2016 changes allowing home administration, extending the gestational window and permitting qualified nonphysicians to prescribe. Under the constitutional doctrine then in force, Judge Theodore Chuang would weigh the rule’s current benefit against its burden.

The Cost of an Encounter

Other federal health policies had already changed in response to COVID-19. Agencies encouraged delivery and telemedicine, relaxed selected REMS procedures for other medicines and expanded remote Medicare services. A controlled-substance telemedicine exception allowed clinicians to forgo an otherwise required in-person evaluation. Those measures recognized that a visit itself could create a health risk.

The coalition’s evidence followed the trip beyond the clinic door. A patient might need public transportation or a shared ride, encounter staff and other patients, then return to household members or caregivers. Closures and reduced hours could delay treatment within a limited gestational window. Transportation and childcare costs bore especially heavily on communities already suffering disproportionate illness and economic loss.

The government contested both the magnitude of an individual patient’s risk and the basis for treating the country alike. Infection rates and restrictions varied by place and time, it argued, while health officials had the expertise to assess the complete safety record. The dispute required Chuang to decide whether that institutional judgment justified the same mandatory visit throughout a changing emergency.

The July Injunction

On July 13, 2020, Chuang granted preliminary relief on the Fifth Amendment due-process claim. FDA could no longer enforce the in-person dispensing and signature requirements against medication-abortion patients during the period specified in his order. The other REMS safeguards remained binding, and clinicians could still require an in-person assessment when appropriate.

The coalition’s membership helped determine the order’s reach. Alongside ACOG stood the Council of University Chairs of Obstetrics and Gynecology, the New York State Academy of Family Physicians, SisterSong Women of Color Reproductive Justice Collective, and Dr. Honor MacNaughton. They brought the experience of medical institutions, community organizations and individual physicians into the case.

ACOG alone had more than 60,000 members, with practitioners in every state and roughly ninety percent of the nation’s obstetrician-gynecologists. Relief for those members and their patients already extended across the country; the injunction also protected others similarly situated.

The order did not extend to miscarriage treatment. Chuang found the preliminary equal-protection record insufficient to establish that the proposed comparator drugs were similarly situated or that the different treatment lacked a rational basis. He also fixed an endpoint: resolution of the case or thirty days after the federal public-health emergency ended, whichever came first. The relief addressed the emergency’s burden without permanently revising the REMS.

The government sought a stay in the district court and then the Fourth Circuit. Both requests were denied, the appellate order arriving on August 13. Those denials kept delivery available to covered patients while the litigation continued; they did not finally resolve the underlying claim.

MacNaughton’s Patients

When the government brought its emergency application to the Supreme Court in August 2020, Kaye was counsel of record for the respondent coalition. On October 8, the Court held the application in abeyance and asked the district court to consider whether changed circumstances warranted dissolving, modifying or staying the injunction.

In the renewed proceedings, MacNaughton described what delivery had meant in her practice. One patient with several risk factors for COVID-19 had left her job to avoid exposure and struggled to find an appointment during the clinic’s reduced hours. Another lived with two elderly relatives and a young child, had no car and would need public transportation or a shared ride. A third had three children attending school remotely and lacked childcare. MacNaughton had evaluated these patients by telemedicine; they received the medicine by delivery and took it without logistical or medical complications.

The government offered no patient evidence of harm from temporary nonenforcement. It instead pointed to differing state restrictions and infection trends, advances in testing and vaccines, and adaptations by medical offices. It also invoked a Fourth Circuit warning against nationwide relief based on pragmatism alone. Chuang found that the sharply rising national cases and deaths, continuing obstacles to care and coalition’s geographic breadth still supported the injunction. On December 9, he refused to stay it generally, in part or in selected regions.

The Supreme Court stayed the injunction on January 12, 2021. Chief Justice John Roberts emphasized deference to politically accountable officials responsible for the pandemic response; Justices Sonia Sotomayor and Elena Kagan dissented from restoring the in-person requirement. The stay restored that requirement during the appeal. The emergency order left the constitutional merits and the permanent REMS undecided.

The FDA’s Own Review

On April 12, 2021, FDA announced that it would exercise enforcement discretion over the in-person dispensing requirement and related signature process for the remainder of the public-health emergency. That decision reopened delivery through agency action. It followed a distinct court-ordered interval, July 13, 2020, through January 12, 2021. During the nonenforcement periods, mail-order pharmacies could hold product for certified prescribers and ship it to named patients on prescription.

Kaye also led the ACLU’s broader challenge to the mifepristone REMS in Chelius. The agency’s 2021 review considered literature references from that litigation alongside published research, safety and adverse-event data, and information from applicants, individuals and advocacy groups. The pandemic case had secured a nationwide interval of controlled delivery; the broader litigation put the continuing restrictions before the agency for review.

FDA announced on December 16, 2021, that it would remove mandatory in-person dispensing and add pharmacy certification. The applicants then submitted formal modifications, which the agency reviewed and approved on January 3, 2023. That regulatory judgment belonged to FDA under its statutory authority and drew on a record extending beyond either lawsuit.

The revised shared REMS permitted dispensing in person or by mail through a certified prescriber or a certified pharmacy filling that prescriber’s prescription. Prescribers continued to complete a Prescriber Agreement and accept the clinical and emergency-care responsibilities, patient counseling, signed agreement and document delivery already required. Pharmacies now completed their own agreement, received prescriber documentation, used shipping with tracking information and ensured prompt dispensing. FDA continued postmarketing monitoring and reported that its reviews had identified no new safety signals.

Kaye welcomed the expanded pharmacy access but regarded the remaining prescriber certification, new pharmacy certification and special patient form as further barriers. In January 2023, she said the agency’s actions “fall short of what science and justice demand.” Mandatory pickup had ended; her challenge to the remaining special restrictions continued.

The Route Returns to Court

Louisiana v. FDA, filed in 2025, brought a separate Administrative Procedure Act challenge to the 2023 dispensing rules while FDA undertook another comprehensive review. Different plaintiffs, claims, evidence and counsel now placed mail and pharmacy access before the courts.

On April 7, 2026, the district court denied Louisiana’s request to suspend the 2023 REMS without prejudice and paused the case for the agency’s review. It weighed reliance on the existing system, varying state abortion laws, parallel suits and the breadth of nationwide relief. FDA had to produce the administrative record within sixty days, report on its progress within six months and proceed with all deliberate speed.

The Fifth Circuit reached a different balance on May 1. It credited Louisiana’s asserted sovereign and Medicaid injuries and found a strong likelihood of success. In the panel’s view, FDA had relied on missing data from its adverse-event reporting system after reducing reporting requirements, together with literature insufficient by itself to support the change. Its order under section 705 of the Administrative Procedure Act would suspend the 2023 remote-dispensing route during the appeal.

On May 14, the Supreme Court stayed that order pending the appeal and any timely certiorari proceedings; Justices Clarence Thomas and Samuel Alito dissented. The Fifth Circuit heard argument on September 9, 2026, while the Supreme Court’s stay preserved mail and certified-pharmacy dispensing during the review.

Kaye spoke about that later case for the ACLU as a senior staff attorney in its Reproductive Freedom Project. Her role there was distinct from her leadership of the pandemic lawsuit and the broader Chelius challenge. The access she had helped secure remained in use as another court considered whether patients would again have to travel to collect the medicine.