FDA v. Alliance for Hippocratic Medicine: A Threat to Mifepristone Access and Women’s Reproductive Rights

Posted on by BUJPH

By Catherine Kawaja

 

INTRODUCTION

The mifepristone-misoprostol regimen is the most common form of medication abortion in the United States. It is highly effective, often considered easier than surgical abortion, and can be less expensive. Mifepristone, when added to the misoprostol regimen, causes few side effects and increases the efficacy of medication abortion. Mifepristone makes medication abortion a more feasible and desirable option for women.1 After the Supreme Court held that there is no constitutional right to an abortion in Dobbs v. Jackson Women’s Health Organization in 2022, many states have passed abortion bans and restrictions. Mifepristone has become even more essential given the limited access to surgical abortion treatment in the post-Roe v. Wade era.

Mifepristone access is currently at risk because Alliance for Hippocratic Medicine (AHM) (an anti-abortion advocate group of medical professionals) is challenging the FDA’s approval of mifepristone. If the Supreme Court decides to take this case, a potential ruling in favor of the plaintiffs could create a massive, negative impact on women’s health and autonomy in the United States. In this paper, I will first examine the rates of use, satisfaction, and complications of mifepristone to understand the public health implications of the FDA v. Alliance for Hippocratic Medicine case. I will review the current FDA guidelines for mifepristone and how different state laws impact mifepristone access. I will then consider the progression of the case through the lower courts. Next, I will analyze the AHM’s likelihood of success in the Supreme Court. I will consider how the Supreme Court may perceive AHM’s alleged injury as well as the AHM’s standing and request for preliminary injunctive relief. Finally, I will conclude by addressing policies for improving mifepristone access as it currently stands and actions that could be taken to mitigate the impact of a Supreme Court ruling in favor of the AHM.

 

USE OF MIFEPRISTONE IN THE UNITED STATES

A.1 Rates of Use

Abortion is a widespread practice in high demand in the United States.2 Twenty-five percent of women will have an abortion within their lifetime, and 60% of abortions in 2017 occurred before 10 weeks (the maximum gestational period allowed to be eligible for medication abortion).5 Seventy five percent of women seeking abortion care are poor or low-income, and 60% are women of color.26 In 2020, 54% of all US abortions were medication abortions.13 From an international perspective, mifepristone is approved in 60 countries.13

 

A.2 Choosing Medication Abortion

Women choose medication abortion over surgical abortion for a variety of reasons. Some women do not want a procedural intervention, believe medication abortion is safer, and consider it “more natural.”5 Some perceive medication abortion to be more private.5 Cost also plays a role: medication abortion is often less expensive than surgical abortion. However, patients must weigh the fact that medication abortion is slightly less effective and takes more time than uterine aspiration (surgical abortion).5 These factors can often overlap in influencing the patient’s decision.

 

A.3 Eligibility for Medication Abortion

The FDA has approved the mifepristone-misoprostol regimen for medication abortion up to 70 days of gestation.14 The American College of Obstetricians and Gynecologists recommends that clinicians confirm a patient’s pregnancy and estimate gestational age when evaluating patients for medication abortion.5 If patients have regular menstrual cycles, report their last menstrual period within the last 56 days, and show no indications or risk factors for ectopic pregnancy, ACOG advises that clinical or ultrasound examination are not required for a prescription for medication abortion.5

Medication abortion is preferable to surgical abortion when patients have specific health conditions.1 These conditions include uterine fibroids causing significant cervical canal distortions, congenital uterine anomalies, and intoital scarring due to infibulation.5 Medication abortion is not recommended when patients have certain risk factors, such as ectopic pregnancy or an intrauterine device in place.5 ACOG indicates that doctors can still prescribe medication abortion to patients with “significant comorbidities,” but they will likely require more monitoring.5 Providers may not prescribe medication abortion when patients seem unwilling or unable to follow the medication abortion instructions, want a faster abortion process, or are unavailable for follow-up.5

 

A.4 Mifepristone Efficacy

Misoprostol can be used on its own for medication abortion, but the combined mifepristone-misoprostol regimen is much more effective. The two trials supporting mifepristone’s approval found 97% and 96% of patients respectively had a complete medical abortion taking the regimen in the first seven weeks.31 More recent data from 2019 found similar complete abortion rates of 95% of women up to 63 days of gestation and 93% at 64-70 days.21 In contrast, only 78% of women taking misoprostol alone had complete abortions without surgery.21

 

A.5 Medication Abortion Regimen and Follow Up

Patients take 200 mg of mifepristone orally followed by misoprostol taken within 24-48 hours either vaginally (most effective), orally, buccally, or sublingually.5 The regimen can be taken safely at home. Medication abortion causes heavier bleeding and more severe cramping than menses.5 Although adverse effects may occur following mifepristone ingestion, they are more common after misoprostol.5 These include: “nausea (43-66%), vomiting (23-40%), diarrhea (23-35%), headache (13-40%), dizziness (28-39%), and thermoregulatory effects such as fever, warmth, hot flushes, or chills (32-69%).”5

ACOG contends that follow-up assessment is unnecessary if patients experience no complications.5 However, the FDA recommends that patients follow up with their healthcare provider 7-14 days after taking mifepristone.27 Remote assessment via phone or telehealth appointment can be sufficient. Patients and clinicians are correct 96-99% of the time when they use symptomatology to conclude that medication abortion has been successful.5 Clinical follow-ups typically use transvaginal ultrasonography to check for the presence of the gestational sac.5

 

A.6 Mifepristone Complications

Medication abortion has a low risk for serious complications. In over 10,000 medication abortions, mifepristone had a 0.3% rate of adverse events and a 0.2% rate of hospitalization for abortion-related reasons.5 Studies have shown no evidence of association between prior medication abortion and subsequent preterm births.5 If patients report an incomplete medication abortion or ongoing pregnancy, they can be given a second dose of misoprostol or be treated with uterine aspiration.

 

A.7 Satisfaction

Most women have positive experiences with medication abortion. Grossman et al. (2021) found that 84.4% of women surveyed were “very (65.4%) or somewhat (19%) satisfied with their medication abortion experience.”14 67.9% of women reported that they would recommend the mifepristone-misoprostol regimen to friends in similar situations.14

 

FDA APPROVAL

B.1 FDA Guidelines

Mifepristone has been subject to more regulation by the FDA than most prescription drugs since its approval in 2000. This scrutiny is especially abnormal given mifepristone’s low risk for complications. Originally, mifepristone’s FDA approval was predicated on a safety program, which allowed only physicians with the capacity to perform certain abortion and pregnancy-related procedures to offer mifepristone.31 These physicians were required to be able to diagnose ectopic pregnancies and estimate pregnancy duration. Mifepristone could only be given in-person by clinics, medical offices, and hospitals within the first 7 weeks of gestation.31 By 2011, mifepristone had an official Risk Evaluation and Mitigation Strategy (REMS) that officially described this safety program.

In 2016, the FDA revised the REMS to extend mifepristone’s approved use to 10 weeks.31 The 2016 revision also altered the required number of in-person visits from three to one and allowed non-physician health care providers licensed by state law “to prescribe and dispense drugs [other than mifepristone], such as nurse practitioners, to prescribe and dispense mifepristone.”20 The 2016 changes also lowered the dosage of mifepristone from 600 mg to 200 mg and removed a prior requirement that mifepristone prescribers had to report non-fatal adverse events. The FDA deemed this requirement unnecessary due to mifepristone’s low complication rate and because mifepristone’s sponsor could submit annual reports of non-fatal adverse events instead.20

In April 2021, the FDA announced that they would not be enforcing the in-person dispensing requirement. The FDA now allows the drug to be dispensed by pharmacies as long as pharmacies and health care providers hold a certification requirement and patients are given counseling.20 In January 2023, the FDA officially altered the REMS to include this new rule.27 Under the current REMS, patients are also required to review and sign a Patient Agreement Form.

 

ACCESSIBILITY

C.1 State Restrictions

Mifepristone is difficult to access and even unavailable in many parts of the United States. Since Dobbs, thirteen states (Alabama, Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and West Virginia) have imposed a “near-total ban on [any form of] abortion.”18Fifteen states limit access to medication abortion by mandating medication abortion provision by a physician (rather than a non-clinician health provider as allowed by the FDA).18 Some of these states require patients to take mifepristone in a physician’s presence, impose arbitrary gestational age limits, and prevent mailing medication abortion pills to patients.18

 

C.2 Barriers to Access

Women also face geographical, financial, and societal barriers to obtaining medication abortion. In 2018, only 65% of women lived within a 30-minute drive to an abortion-providing facility.22 This number rose to 89% for a 90 minute drive-time.22 Since Dobbs, these driving times have likely increased drastically due to the concentrated number of states in the Midwest and Southern United States with abortion bans.22 Patients are impacted by limited hours of operation of abortion clinics and pharmacy staff and providers’ cultural competency.22 Women struggle to take time off work or find childcare for in-person appointments.11 Even since the FDA allowed pharmacist-dispensed mifepristone, patients still experience long wait times, inadequate pharmacist knowledge of medications, and failures by pharmacists to dispense all prescribed medications.4 Costs also prevent women from attending clinical appointments. Transportation to clinics can be a financial burden, and out-of-pocket costs for medication abortion exceed $500.6 For many women, choosing a medication abortion can mean sacrificing essential needs such as rent, food, and childcare.

Abortion stigma makes it more difficult for women to access medication abortion. Women are often reluctant to ask providers extensive questions about the types of abortion care available to them (or even about abortion care in general).23 Women seek extensive privacy to ensure that they do not face judgment from their communities. Providers can create barriers by not providing medication abortion or having a negative attitude toward abortion care. Grossman et al. (2019) found that physicians do not provide medication abortion most commonly due to personal beliefs (34%) and practice restrictions (19%).15 Women also reported negative pharmacist attitudes when acquiring pharmacist-dispensed mifepristone.14

 

FDA v. ALLIANCE FOR HIPPOCRATIC MEDICINE

The FDA v. Alliance for Hippocratic Medicine case currently being decided by the Supreme Court is the greatest threat to mifepristone access in the United States today. The AHM, the leading plaintiff, filed their lawsuit against the FDA in federal district court in Amarillo, Texas in November 2022. This district court was an ideal location for the AHM’s suit because it has only one judge: the highly conservative Judge Kacsmaryk. The AHM sought preliminary injunctive relief from multiple administrative actions of the FDA. The AHM asked the Court to order the FDA to withdraw or suspend “1) FDA’s 2000 Approval and 2019 Approval of mifepristone tablets, 200 mg, thereby removing both from the list of Approved Drugs; 2) FDA’s 2016 Changes and 2019 Generic Approval [of mifepristone as Mifeprex]; and 3) FDA’s April 12, 2021, Letter and December 16, 2021 […] concerning the in-person dispensing requirement for mifepristone.”3

 

D.1 Alliance for Hippocratic Medicine Argument

The AHM argued that the FDA’s approval and subsequent actions violated the Administrative Procedure Act by “overlook[ing] important safety risks.”4 The Administrative Procedure Act gives federal courts the power to “hold unlawful and set aside agency action, findings, and conclusions found to be arbitrary, capricious, an abuse of discretion or otherwise not in accordance with the law.”4 The AHM’s alleged injury was specifically related to the impact of mifepristone’s complications. When AHM’s doctors treat individuals who are experiencing complications from mifepristone, they claim that they are required to take part in the process of either performing or facilitating an abortion. This practice violates their “sincerely held moral beliefs,” interferes with the time and resources needed for their other patients, creates “substantial mental and emotional distress,” and creates a higher risk for malpractice and insurance costs.4

 

D.2 District Court Ruling and Subsequent Stay Proceedings

Although Judge Kacsmaryk found that the AHM had standing to file their suit and satisfied all the conditions required for preliminary injunctive relief, he instead issued a stay under §705 of the Administrative Procedure Act. Under §705, the Court can postpone the challenged FDA’s mifepristone actions pending judicial review.3 This ruling blocked the FDA’s original approval of mifepristone in 2000.2 Before the stay went into effect, Judge Kacsmaryk stayed the applicability of his own decision to provide the federal government seven days to seek emergency relief from the Fifth Circuit Court of Appeals. On April 12, 2023, a panel of the Fifth Circuit issued a ruling that reversed the district court’s stay of the 2000 approval but reverted mifepristone access to pre-2016 FDA restrictions. However, the Supreme Court issued a stay on the decision pending their own review of the case.

 

D.3 Fifth Circuit Ruling 

In August 2023, after further briefing and oral argument, the Fifth Circuit issued an opinion largely similar to the Fifth Circuit stay panel’s decision. The Fifth Circuit found that the AHM had standing to challenge the FDA’s actions and had satisfied the requirements for a preliminary injunction on the 2016 and 2021 requirements. The Fifth Circuit thus affirmed the district court’s stay of the 2016 Amendments and of the 2021 non-enforcement of the in-person dispensing requirement.

 

D.4 Current Status

The Supreme Court agreed to review the case on December 13, 2023. Until the Supreme Court issues their decision (expected in summer 2024), Mifepristone remains accessible under current REMS requirements.

 

CONSIDERATIONS FOR POTENTIAL SUPREME COURT RULING

E.1 Likelihood of an Unfavorable Ruling For The FDA

In the post-Dobbs era, many are concerned that there may be no abortion restriction too extreme for the current 6-3 conservative majority on the Supreme Court. The Court’s recent prioritization of religious freedoms over other fundamental rights suggests they would be sympathetic to the AHM’s claim of moral injury.5 Even though the Alliance case concerns the Administrative Procedure Act (which makes the case about the Court’s review of FDA actions, not abortion), anti-abortion sentiment could influence the Supreme Court’s approach to the case in the same way it did the lower courts. Instead of the correct term for the mifepristone-misoprostol regimen (medication abortion), both lower-court opinions used the term “chemical abortion,” which ACOG explains is a “biased term” that makes medication abortion seem like a more dangerous procedure.1 Both rulings also described fetuses as “unborn babies” or “unborn humans” and emphasized how mifepristone “kill[s] the unborn human.”34 This biased characterization of abortion has no place in what should be the Court’s “careful” review of agency action under the Administrative Procedure Act.4 The Court’s recent Dobbs opinion was also full of terms such as “abortionist” and “unborn child” that ACOG describes as prejudiced.10

 

E.2 Argument For A Favorable Ruling For The FDA

AHM and Other Associations Lack Standing6

AHM and the other associations challenging the FDA lack standing because their risk of future injury is incredibly low and relies on “a series of contingencies.”20 Mifepristone’s adverse complication rate is 0.3%, and it results in a complete end of pregnancy 96%-97% of the time.31,5 The AHM’s stated future injury thus assumes that 1) enough women will have a complication to be seen by multiple doctors part of these associations; 2) the women experiencing incomplete abortions will require surgical abortion rather than another dose of misoprostol; 3) the women will go to the emergency room instead of the provider who prescribed the mifepristone; and 4) “despite federal conscience protections,” the doctors part of the AHM will be “forced to provide the care rather than referring the woman to a non-objecting doctor.”20 Standing based on a “speculative chain of possibilities” (Clapper v. Amnesty Int’l USA (2013))8 and “unfettered choices made by independent actors” (Lujan v. Defenders of Wildlife (1992))16 has been rejected by the Court.20 There is also no “substantial risk” of future injury to establish associational standing because only some members of these associations may be injured.20 Prospective relief cannot be based simply on their stated “past injur[ies]” (Summers v. Earth Island Institute (2009).25 After more than 23 years of mifepristone use, the Fifth Circuit only cited three doctors who had experienced conscience injuries. The AHM’s risk of future injuries is thus speculative at best and insufficient to establish standing.

Furthermore, the FDA did not impose direct injury on the AHM. The FDA’s actions do not force emergency room doctors to prescribe the drugs or to take care of patients with post-mifepristone complications.20 The FDA’s changes also do not require patients to take mifepristone or to go to the emergency room if they experience a complication or incomplete abortion.20 Thus, the AHM also does not have standing because their risk of future harm is not “fairly traceable” to the FDA’s mifepristone REMS changes.20

 

Even if the Supreme Court Were To Find That The AHM Has Standing, The AHM Fails to Meet The Requirements for Preliminary Injunctive Relief7

The FDA’s actions were not “arbitrary and capricious,” and thus the AHM is not likely to succeed on the merits.20 The FDA’s changes to their mifepristone REMS were based on extensive data from the US and other countries over more than twenty years. The FDA examined studies that took into account the impact of their proposed changes on an individual basis and grouped together. Mifepristone was shown to be safe in every study. The lower courts’ disregard for the FDA’s expertise in conducting scientific research and drug trials reflects an overly-activist approach. The Court has recognized that when parties disagree about public health matters, ““courts owe significant deference to the politically accountable entities with the ‘background, competence, and expertise to assess public health” (FDA v. American Coll. of Obstetricians & Gynecologists (2021), Roberts concurring).12 Instead of following this logic, the lower courts ignored the clear facts showing the FDA’s careful reasoning for their mifepristone changes.

Reverting mifepristone access back to pre-2016 restrictions would create a substantial harm to “the government, mifepristone’s sponsors, women seeking medication abortions, and the public” that outweighs the AHM’s potential injury.20 The FDA and drug sponsors would be forced to re-label all mifepristone to pre-2016 conditions, so current “extant” mifepristone could no longer be offered.20 Women and physicians would be forced to comply with requirements (such as reducing eligibility to 7 weeks and requiring multiple in-person visits) that the FDA has found unnecessary.20 The “disruptive alteration of the status quo” of the last seven years would not serve the public interest.20 Instead, the 54% of women who use medication abortion to terminate their pregnancies would experience further barriers to accessing an effective and safe drug.13

 

POLICY PROPOSALS TO MITIGATE AN UNFAVORABLE RULING

If the Supreme Court rules in favor of the AHM, Congress could take action to mitigate the reduced access to mifepristone. The Protecting Access to Medication Abortion Act (S. 237 and H.R. 267) would codify the current FDA REMS by mandating that the FDA allow patients to obtain mifepristone from telehealth and certified pharmacies.29 The Protecting Reproductive Freedom Act would limit states’ authority to restrict the mailing of medication abortion across state lines or to impose requirements for in-person dispensing or prescribing.24 The Freedom to Decide Act would codify the DOJ’s interpretation of the Comstock Act (an archaic law criminalizing mailing of medications used for abortion materials and invoked by the district court in the Alliance case) as not prohibiting the sending of medication abortion when the sender does not know whether the recipient will use the medication abortion regimen unlawfully.28 Although these proposals all effectively target clear implications of the Alliance case, their biggest problem is their odds of success. Although 69% of Americans believe abortion should be legal in the first trimester (thus encompassing the period of medication abortion eligibility), the intense political polarization in Congress suggests that a bill protecting medication abortion is unlikely to succeed.30

Certain states have taken action to protect medication abortion access. State governors in Massachusetts, Washington, and New York requested that their states stock doses of mifepristone to avoid the risk of potential shortages should a ruling disrupt the pharmaceutical industry. California governor Newsom announced plans to buy “up to 2 million doses of misoprostol” to be used in case mifepristone access is restricted.19 Illinois governor Pritzker announced that the state is offering “providers Medicaid advances for both mifepristone and misoprostol to ensure they have abortion medication.”19

 

POLICY RECOMMENDATIONS TO IMPROVE CURRENT MIFEPRISTONE ACCESS

Increasing the availability of medication abortion will mitigate women’s privacy, cost, and logistical concerns. Ensuring more pharmacies are certified to stock mifepristone and misoprostol is key. 74.3% of women would recommend receiving medication abortion from pharmacies, and 62% would rather have it available at pharmacies through prescriptions by primary care clinics.14 ACOG and other medical groups have called for the Biden administration to end their pharmacy certification requirement, which would allow all pharmacies to dispense mifepristone like any other drug. Telemedicine is another potential solution. Seymour et al (2022) found that removing all state bans on telemedicine for abortion and expanding telemedicine services would significantly improve abortion accessibility.22

 

LEGAL STRATEGY TO CHALLENGE STATE RESTRICTIONS ON MIFEPRISTONE

By limiting mifepristone in a manner inconsistent with the FDA’s REMS, states “thwart FDA’s mission to promote public health through helping to ensure the availability of safe and effective drugs.”31 Zettler, et al. (2022) explains that courts could find states’ authority to regulate medicine does not extend to the “power to regulate medical practice in ways that make compliance with FDA requirements impossible.”31 However, if challenges fail in the courts, they could create a precedent that undermines the FDA’s power to regulate mifepristone and other drugs. On the other hand, a successful challenge could have unintended negative implications on states’ role in regulating other drugs, such as opioids.

 

CONCLUSION

Mifepristone is a widely used, highly efficacious, favored, and low-risk drug for medication abortion. A Supreme Court ruling limiting mifepristone would only exacerbate existing disparities in abortion care. Patients will have to resort to misoprostol-only medication abortion, which will cost more (due to more rounds) and be less effective.9 Women will experience more pain when repeated doses of misoprostol are necessary. Women may have to wait longer to have abortions due to these limitations, leading to riskier second-trimester abortions. The FDA has a strong legal argument against the AHM, and the Court’s restriction of access to mifepristone based on the AHM’s speculative injury would be unprecedented.

===FOOTNOTES===

1 Disclaimer: Although not every person who wants or has an abortion identifies as a “woman,” this is the term I used in this paper to remain consistent with the majority of the studies I found, which for the most part used the terms “women” and “patients” to describe individuals eligible for abortion care.

2 Dobbs has drastically limited abortion access. The majority of the studies discussed in this section are limited because they only examine pre-Dobbs use of medication abortion. Many expect Dobbs to decrease medication abortion use, but this data has not been adequately collected in the short timeline since the ruling.

3 On Standing: The AHM’s suit first relied on the court ruling in their favor on a key legal standard: standing. Article III of the Constitution’s case-or-controversy requirement means that AHM must have standing to sue the FDA. Specifically, the AHM must have a clear injury traceable to the FDA’s conduct and redressable by the Court’s decision.4 Furthermore, the AHM needed to prove associational standing to sue on behalf of their members.

4 On Preliminary Injunctive Relief: The standard for preliminary injunctive relief requires “1) a substantial likelihood of success on the merits, 2) a substantial threat of irreparable harm, 3) that the threat of injury outweighs any harm than an injunction would cause, and 4) that the public interest is not disserved by an injunction” (Garcia v. Jones, 910 F.3d 188, 190 (5th Cir. 2018)).

5 As exemplified by Burwell v. Hobby Lobby, 573 U.S. 682 (2014),7 (finding for-profit companies could not comply with the ACA’s contraceptive coverage requirement for their employees if it violated the company’s religious beliefs), Masterpiece Cakeshop v. Colorado Civil Rights Commission, 138 S. Ct. 1719 (2018),17 (finding “religious and philosophical objections to gay marriage are protected views and in some instances protected forms of expression” by the Free Exercise Clause of the First Amendment), and 303 Creative v. Elenis, 600 U.S. 570 (2023)32 (finding that public accommodations could not be required to comply with anti-discrimination law in their expression if it violated their religious beliefs).

6 See citation 9 on standing.

7 See citation 10 on preliminary injunctive relief.

 

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  31. Zettler, P. J., Beckmeyer, A., Brown, B. L., & Sarpatwari, A. (2022). Mifepristone, preemption, and public health federalism. Journal of Law and the Biosciences, 9(2). https://doi.org/10.1093/jlb/lsac037.
  32. 303 Creative v. Elenis, 600 U.S. 570 (2023).
Catherine Kawaja