Mifepristone-initiated medication abortion1 is a safe and effective method of terminating a pregnancy. However, access to mifepristone has been stringently regulated by the Food and Drug Administration (FDA) since the drug was first authorized for distribution in 2000.2 The agency has always imposed intensive dispensing restrictions, including in-person prescription and counseling processes.3 But on December 16, 2021, during a year when reproductive rights appeared increasingly vulnerable,4 the Biden FDA offered a glimmer of hope to reproductive rights advocates. In response to medical professionals’ advocacy, the agency removed the federal in-person dispensing requirement for medication abortion5 from mifepristone’s drug protocols — the Risk Evaluation and Mitigation Strategy (REMS) for Mifepristone)6 — allowing pregnant people in thirty-one states to access medication abortion by mail.7
While the REMS update is an important victory that demonstrates how medical professionals can successfully advocate for broader abortion access through administrative agencies, its precarity ultimately reveals the practical and doctrinal limits of agency action as an avenue for reproductive rights advocacy. Since the approval of mifepristone (Mifeprex) in 2000, the FDA has required patients seeking medication-abortion pills to visit certified clinics, often traveling prohibitively long distances or crossing state lines. 8
This in-person requirement was part of the FDA’s REMS protocols for mifepristone9 and mirrored requirements for high-risk medications such as injectable schizophrenia drugs.10 During the COVID-19 pandemic, the FDA exercised enforcement discretion to relax the in-person dispensing requirement for many riskier drugs subject to REMS, reasoning that making these medicines mailable reduced coronavirus transmission risks.11 Still, the agency continued enforcing stringent in-person dispensing protocols for mifepristone for another year, incurring accusations of political bias based on mifepristone’s use as an abortifacient.12
On April 20, 2020, two medical professional organizations — the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) — sent a letter to the FDA, urging the agency to lift the in-person dispensing requirement for mifepristone.13 Submitted on behalf of 60,000-plus obstetric-gynecologists, the letter argued that the requirement put patients and providers at unnecessary risk of COVID-19 transmission in seeking a time-sensitive healthcare service.14 Trump–FDA Commissioner Stephen Hahn did not acknowledge this letter. On May 27, 2020, ACOG filed suit in the U.S. District Court for the District of Maryland, seeking to enjoin enforcement of the FDA’s in-person dispensing requirement during the pandemic.15 ACOG complained that the FDA retained the mifepristone in-person dispensing requirement against medical authorities’ advice,16 evincing discriminatory treatment of mifepristone prescribers and patients due to bias arising from mifepristone’s status as an abortion drug.17 The court granted ACOG’s preliminary nationwide injunction, allowing mifepristone to be dispensed by mail during the COVID-19 pandemic.18 Applying the undue burden test from Whole Woman’s Health v. Hellerstedt19 and June Medical Services v. Russo,20 the court found that the in-person dispensing requirement imposed “a ‘substantial obstacle’” to patients’ free exercise of the fundamental right of choice.21
The Trump FDA filed for an emergency stay of the injunction, hoping to continue to enforce the in-person requirement.22 The case was remanded to and reaffirmed by the district court.23 The FDA then renewed its stay application,24 and upon review, the Court granted the stay, reinstating in-person dispensing requirements on January 12, 2021.25 Chief Justice Roberts cited a need for agency deference during the pandemic.26 Justice Sotomayor dissented,27 writing that this decision flouted the Court’s undue burden test.28
On April 12, 2021, a few months after President Biden’s inauguration, the Biden FDA issued a letter (“the Letter”) announcing that it would not enforce the in-person dispensing requirement for mifepristone.29 The Letter, from Acting Commissioner Janet Woodcock, was addressed to ACOG and SMFM, in response to their April 20, 2020 letter.30 The Letter authorized mail distribution of mifepristone via “enforcement discretion” regarding pandemic-context in-person protocols.31 It marked the first time that the in-person dispensing requirement for mifepristone had been lifted, making it the most significant federal liberalization of medication-abortion access at the time. On May 7, 2021, the FDA initiated a voluntary full review of the overall REMS protocols, in response to the ACOG litigation and to a pending 2017 lawsuit challenging the constitutionality of a REMS protocols for mifepristone.32
On December 16, 2021, FDA released a REMS update following the review. In another letter to a group of medical professionals who had challenged the constitutionality of the REMS,33 the FDA announced that it would remove the in-person dispensing requirement, allowing certified pharmacies to mail mifepristone pills.34 The FDA accordingly revised the Medication Guide and informational materials.35
Although the REMS update was an important victory that illustrates how medical professionals can successfully lobby for broader abortion access through administrative agencies, the precarity of this agency action evinces the practical and doctrinal limits of agency advocacy as an avenue toward reproductive freedom. In the short term, this agency advocacy is undeniably effective. The update significantly expanded abortion access for pregnant people in most states. It is unlikely to face judicial scrutiny due to jurisprudence surrounding both agency deferenceand Article III standing. Still, while the update expands abortion access, its limits demonstrate agency action’s constraints. Overall, the FDA’s limited jurisdiction covers medication but not surgical abortion. Even for medication abortion, barriers remain. Legally, the update is limited by state laws’ potential to be more restrictive than FDA regulations, as well as by the possibility of a future administration reinstating the in-person requirements, which would likely withstand legal challenge.
Pragmatically, lifting the in-person requirement expands abortion access. Pregnant people in thirty-one states can now access mifepristone-misoprostol medication abortion by mail, either from a certified prescriber or a mail-order pharmacy.36 This is especially significant in the context of the broader rise of medication abortions (in 2019, nearly forty-four percent of U.S. abortions).37 Medication abortion retains several advantages over surgical abortion. It is safe to manage on one’s own38 and enlarges the range of abortion providers; in eighteen states pills for termination can be provided by qualified nonphysician professionals.39 Moreover, self-managed abortions are harder to capture or eliminate with Targeted Regulation of Abortion Providers (TRAP) laws,40 and providers offering telemedicine counseling are exposed to less risk of bias-driven violence than those performing surgical abortions in clinics.41 The update instantiated medical abortion as a more prominent feature of the shifting national abortion-access landscape.
Agency action can improve abortion access in a manner less susceptible to legal challenge, as Article III standing doctrine insulates REMS updates from judicial review. Despite anti-abortion advocates’ widespread criticism of the update, none have brought legal challenges.42 It is unclear whether any individual or group could serve as a plaintiff because of the lack of a cognizable injury,43 a classic requirement for Article III standing.44 As the Roberts Court narrows standing doctrine,45 a judicial challenge to the REMS update remains difficult.
The removal of the in-person dispensing requirement would likely survive the FCC v. Fox Television Stations46 standard of review that governs agency changes in policy. Fox outlines a standard of arbitrary and capricious review that requires that an agency “examine the relevant data and articulate a satisfactory explanation for its action,”47 and that the agency “display awareness that it is changing position” and “show that there are good reasons for the new policy.”48 The Biden FDA’s rationale included evidence that the safety of medication abortion is unaffected by a lack of in-person dispensing. In 2016, the Obama FDA lengthened eligibility from forty-nine to seventy days’ gestation based on scientific research.49 This change went unchallenged, enabling more than four million safe and effective U.S. medication abortions.50 Barriers to judicial review and likely application of the Fox standard render the update a temporarily incontrovertible victory.
This administrative win has practical limits. The FDA’s purview is restricted to medication abortion, a circumscribed avenue to reproductive freedom. Medication-abortion regimens are authorized until ten weeks into pregnancy, while traditional surgical abortions can occur until twenty-three weeks.51 REMS barriers disproportionately affect the most marginalized pregnant people seeking abortions.52 Racially marginalized, trans*, and nonbinary pregnant individuals face prohibitive challenges beyond travel.53 Access is further constrained by ignorance of the REMS update, exacerbated by a lack of both internet and comprehensive sex education.54 REMS-altering agency advocacy must be driven by medical professionals, which risks perpetuating the prioritization of physicians’ expertise over patients’ self-knowledge and self-advocacy.55 Many advocates thus call for a complete REMS repeal.56
State regulations further restrict the potential effects of this victory. The REMS sets a federal regulatory floor, but states can be more restrictive. Nineteen states — five in 2021 alone — have legislatively mandated in-person dispensing.57 These laws functionally overwrite the FDA guidance, making it impossible for people in those states to access mifepristone by mail. At the extreme, medication abortion is vulnerable to criminal prosecution of self-managed abortions in six states.58 Anti-abortion legislators’ “abortion reversal” campaigns59 presage outright bans on medication abortion and restrictions on provider eligibility.60
Agency actions can also be reversed by an unfriendly administration, and such a reversal would likely withstand legal challenge. A conservative administration could resume enforcing the 2020 REMS in-person dispensing requirement, and administrative law could insulate the decision from judicial review.61 Under Motor Vehicle Manufacturers Ass’n v. State Farm Mutual Automobile Insurance Co.,62 a “rational connection between the facts found and the choice made” in a recission decision could pass arbitrary and capricious review and could justify a policy reversion.63 Although the recent administrative-advocacy archetype has been medical experts seeking to expand abortion access, medical professionals’ willingness to produce anti-abortion rationales for agencies should not be underestimated.64 Even a full REMS repeal would likely last only until the next abortion-unfriendly administration.
Recourse to agencies has provided a momentary victory for access to medication abortion. However, for lasting, expansive access to mifepristone, agency action would have to be bolstered by advocacy to state and federal legislatures. A total repeal of REMS protocols for mifepristone would be the first step toward expanded medication-abortion access. But even if the FDA reverts to a more stringent REMS, states can help protect medical abortion. States can pass legislation to maintain the longest possible time allowance (ten weeks), expand provider eligibility, and even enshrine a right to medical abortion in state constitutions and state law.65 In the wake of the REMS update, advocates for reproductive freedom must strategically weave administrative, judicial, and legislative activism to protect access to medication abortion, an innovative avenue to one of the most polarizing American constitutional rights.