Future Challenges to Abortion Access: Implications Beyond FDA v. Alliance of Hippocratic Medicine

by Cecilia Giles, Associate Member, University of Cincinnati Law Review Vol. 92

Note: Since this article was written, the Supreme Court has ruled in favor of the FDA. The Court unanimously held that the plaintiff-doctors did not have proper standing to challenge the FDA’s actions regarding mifepristone regulation.1 FDA v. Alliance for Hippocratic Med., 602 U.S. No. 23-235 (2024). Because the plaintiff-doctors do not prescribe mifepristone, and the FDA is not requiring them to prescribe it, the plaintiffs failed to establish that they suffered an actual injury as required by Article III of the U.S. Constitution.2Id. 

I. Introduction

Abortion access has been a highly debated topic ever since the Supreme Court ruled that there is no constitutional right to abortion in 2022. Since this ruling, numerous lawsuits have been filed across the country challenging the legality of the procedure as well as access to the necessary medication. At the end of March, the Supreme Court heard oral arguments for one of these cases. FDA v. Alliance of Hippocratic Medicine pertains to the FDA’s actions regarding mifepristone, one of the medications commonly taken to induce an abortion.

Based on oral arguments, the Supreme Court seems prepared to dismiss this case for lack of standing because the plaintiffs have not alleged an injury that is directly attributable to them. However, reproductive healthcare advocates should not view this decision as a win for abortion access. During oral arguments, the Justices referenced other ways in which future plaintiffs could successfully bring a similarly situated case, and win.

Part II analyzes historical case law regarding abortion access, before walking through the current case, FDA v. Alliance of Hippocratic Medicine. Part II then discusses the Comstock Act, one of the laws broached by the Justices during oral arguments. Part III argues that even though it seems that the Court will dismiss this particular case for lack of standing, litigation about reproductive healthcare is far from finished. Part IV will conclude.

II. Background 

A. Case Law Regarding Abortion Access

The Supreme Court first addressed abortion access in 1973. In Roe v. Wade, the Supreme Court found that the constitutional right to privacy included a right to abortion.3Roe v. Wade, 410 U.S. 113, 153 (1973). In this case, the Court found that a Texas statute which limited abortions to only those medically necessary to save the life of the mother was unconstitutional.4Id. at 164. The Court established a test for determining whether or not the state could interfere with a mother’s decision to terminate her pregnancy based on what trimester she was in.5Id. at 163. In the first trimester, the decision to terminate a pregnancy rested solely with the mother.6Id. During the second trimester, the state could regulate, but not outlaw, abortions in consideration of the mother’s health.7Id. Finally, in the third trimester, the state could regulate or outlaw abortions in order to preserve the potential life.8Id.

The Court reaffirmed the constitutional right to an abortion in Planned Parenthood v. Casey.9See Planned Parenthood v. Casey, 505 U.S. 833 (1992). In Casey, the Court overturned Roe’s trimester framework in favor of an undue burden test to determine whether a regulation on abortion is constitutionally permissible.10Id. at 954. The undue burden test states that a statute is unconstitutional if it results in an undue burden to a person seeking an abortion.11Id. at 895. The Court in Casey found that a law requiring married women to notify their spouses before obtaining an abortion constituted an undue burden on her right to receive abortion care.12Id. Although disturbing the original framework laid out in Roe, the Casey Court ultimately still found that a woman’s right to an abortion remained constitutionally protected.13Id. at 954.

However, in 2022 all of that changed.14See Dobbs v. Jackson Women’s Health Org., 597 U.S. 215 (2022). The Supreme Court overturned Roe and Casey, in Dobbs v. Jackson Women’s Health Org., when it held that the constitutional right to privacy does not include a right to abortion.15Id. at 292. The court ruled that regulation of abortion should be left up to the states.16Id. at 301. Therefore, in a post-Dobbs society, there is no constitutional right to an abortion.17Id. at 292. By holding that the constitutional right to privacy does not encompass abortion, the Supreme Court has allowed the states to decide whether abortion is legal in their respective jurisdictions. This has led to a patchwork of laws across the country that vary in restrictiveness and access to reproductive healthcare services. Whether or not a woman can terminate her pregnancy depends on the laws of the state she is in.

B. FDA v. Alliance for Hippocratic Medicine

Returning the decision of the legality of abortion to the states has opened the floodgates for a wave of litigation challenging various facets of abortion access across the country. One of these cases reached the Supreme Court in March 2024.18See Petition for Writ of Certiorari, U.S. Food and Drug Admin. v. All. for Hippocratic Med., 144 S. Ct. 537 (2023) (No. 23-10362). In FDA v. Alliance for Hippocratic Medicine, a group of doctors (“Plaintiffs” or “Doctors”) who oppose abortion brought suit seeking to limit the distribution of mifepristone, which is one of two medications commonly taken to induce abortion.19Id. at 2. Despite not prescribing nor being required to prescribe mifepristone themselves, the Plaintiffs argue that they have suffered harm by the FDA’s approval of the drug.20Id. These claims are baseless. There are various statues known as “refusal laws” that allow doctors to refuse to provide an abortion based on moral or religious objections.21Refusal to Perform Abortions, Policy Surveillance Program (2018), https://lawatlas.org/datasets/refusal-to-perform-abortions. The Plaintiffs in this case have never been required to provide abortion care.22Jesse Wegman, An Anti-Abortion Case Too Far Fetched for the Supreme Court, N.Y. Times (Mar. 26, 2024), https://www.nytimes.com/live/2024/03/26/opinion/thepoint/abortion-mifepristone-supreme-court?smid=url-share. They merely have generalized, speculative concerns that one day, they might have to prescribe mifepristone, despite not yet having to do so.23Id.

The Plaintiffs argue that the FDA acted “arbitrarily and capriciously” in approving various changes to the use of mifepristone.24Petition for Writ of Certiorari, supra note 16. The changes that the Plaintiffs are referencing occurred in 2016 and in 2021. In 2016, the FDA approved an application to change the use of mifepristone in three ways: by increasing the gestational age limit from seven to ten weeks, reducing the number of required clinical visits from three to one, and allowing non-licensed health care providers (such as nurse practitioners and physician assistants) to prescribe the drug.25See id. at 21-22. The Plaintiffs also challenged the FDA’s 2021 decision to remove the in-clinic dispensing requirement entirely.26Id. at 25. Removing the in-clinic dispensing requirement meant that people could use telehealth services to obtain a prescription for mifepristone. These changes broadly expanded mifepristone access making it easier to obtain and enabling more people to use the drug to terminate their pregnancies. If the Supreme Court were to rule in favor of the Doctors and hold that the FDA’s decisions were unlawful, access to abortion would be dramatically restricted.27Eve Espey, Tiffany Hailstorks, & Lisa Hofler, Understanding the Impacts of the Supreme Court Case FDA v Alliance for Hippocratic Medicine, J. of the Am. Medical Ass’n (Mar. 25, 2024), https://jamanetwork.com/journals/jama/fullarticle/2816816. By reinstating the pre-2016 rules, patients would be prevented from using telemedicine to obtain abortion medicine and from receiving that medicine by mail.28Id. The pre-2016 rules also prevent other types of providers, such as nurse practitioners and physician assistants, from prescribing mifepristone.29Id.

Lower courts ruled in favor of the Plaintiffs. A judge in Texas issued a decision that revoked the FDA’s approval of mifepristone (although it should be noted that the Plaintiffs purposefully filed this case in a court where they were guaranteed a judge who would be sympathetic to their point of view).30Id. The Fifth Circuit diluted this ruling.31All. for Hippocratic Med. v. U.S. Food & Drug Admin., 78 F.4th 210 (5th Cir. 2023). It did not entirely revoke the FDA’s approval of mifepristone, as the lower court did, but instead reinstated the FDA’s pre-2016 restrictions on mifepristone.32Id. However, the Supreme Court put this ruling on hold until it could decide on the case, meaning that the pre-2016 restrictions never officially went back into effect.

The Supreme Court heard oral arguments for this case on March 26, 2024.33Transcript of Oral Argument, Food and Drug Admin. v. All. for Hippocratic Med., 144 S. Ct. 537 (2024) (No. 23-235). The Justices seemed skeptical of the Doctors’ arguments that they had valid standing.34Id. at 26, 47-49, 73-77. In order to have standing to sue, a plaintiff must show that they personally have suffered an actual injury that can be traced back to the actions of the defendant, and that injury can be redressed by a favorable decision.35U.S. Const. art. III, § 2, cl. 1. In this case, it is hard to argue that the Doctors meet these requirements. The Doctors’ claim of harm is based on the notion that one day, in some hypothetical hospital, with some hypothetical patient, they might be forced to prescribe mifepristone. This hypothetical harm is not concrete or imminent enough to meet the basic standing requirement.

The Supreme Court seems prepared to dismiss this case for lack of standing.36See Transcript of Oral Argument, supra note 31, at 26, 47-49, 73-77 . However, even if the Court dismisses the case, that does not mean that reproductive healthcare access is protected. During oral argument, the justices signaled other ways that abortion could be restricted.37Id. These involve using the idea of fetal personhood38Fetal personhood is the idea that life starts at conception. This idea is outside the scope of this article, but more information can be found at Madeline Carlisle, Fetal Personhood Laws Are a New Frontier in the Battle Over Reproductive Rights, Time (June 28, 2022), https://time.com/6191886/fetal-personhood-laws-roe-abortion/. or the Comstock Act to restrict abortion access.

C. The Comstock Act

The Comstock Act (“Act”) is a federal law that criminalizes sending “obscene” materials through the mail.39What are the Comstock Laws?, Planned Parenthood (May 12, 2023), https://www.plannedparenthood.org/blog/what-are-the-comstock-laws. It authorizes the post office to search mail for any “obscene, lewd, lascivious, indecent, filthy, or vile article, matter, thing, device, or substance” including items related to abortion, birth control, or sexual health.40Id. Under the Act, the post office has the ability to seize not only items related to sexual healthcare, but also art, novels, plays, or even medical textbooks with sexual content.41Id. The law was created by Anthony Comstock, who convinced Congress to pass the Act in 1873.42Id. Comstock had moral objections to sexual content “corrupting” society, and wanted to outlaw it all together. At Comstock’s persuasion, Congress passed the Act, and even went so far as to appoint Comstock as a Special Agent of the U.S. Post Office so that he personally could enforce the law.43Id.

This Act is still on the books today, but has remained largely dormant. Although it has not been explicitly repealed, courts reached an informal consensus that the Act should be interpreted narrowly by the middle of the twentieth century.44Memorandum Opinion for the General Counsel United States Postal Service on the Application of the Comstock Act to the Mailing of Prescription Drugs That Can Be Used for Abortions, Op. O.L.C. (Dec. 23, 2022), https://www.justice.gov/olc/opinion/file/1560596/dl. Specifically, the Act could not be used to prosecute anyone who mailed “obscene” material, unless the material was intended to be used unlawfully. Therefore, with the Supreme Court ruling that abortion was constitutionally protected in Roe v. Wade, the Act officially could not be used to prosecute anyone who sent abortion medication through the mail.

However, now that Roe has been overturned, anti-abortion groups are calling for a revival of the Comstock Act.45Emily Bazelon, How a 150-Year-Old Law Against Lewdness Became a Key to the Abortion Fight, N.Y. Times (May 16, 2023), https://www.nytimes.com/2023/05/16/us/abortion-comstock-act.html. The groups argue that on its face, the Act statutorily prohibits mailing “abortion-causing” materials, and allows up to five years in prison for anyone who does.46Id. Because the law is technically still on the books, it could be enforced by a willing president and Department of Justice. The current administration has no interest in enforcing this Act against abortion. However, a future willing president could order the Department of Justice to start interpreting the Comstock Act to mean that it is illegal to mail mifepristone without any congressional action.47Tina Smith, I Hope to Repeal an Arcane Law That Could Be Misused to Ban Abortion Nationwide, N.Y. Times (Apr. 2, 2024),https://www.nytimes.com/2024/04/02/opinion/comstock-act-abortion-repeal.html.

III. Discussion 

The Supreme Court seems to be prepared to dismiss FDA v. Alliance of Hippocratic Medicine for lack of standing. Justice Kagan called the events described by the Plaintiffs as “probabilistic” (as opposed to the “concrete” Article III requirement).48Transcript of Oral Argument, supra note 31, at 74. However, even if the Court dismisses this case for lack of standing, that does not necessarily mean that the Court believes that healthcare providers should be able to provide mifepristone, or that abortion access is protected. The holding would be limited to the notion of standing. It would merely mean that the Court does not think that these particular Plaintiffs have the proper standing necessary to bring this case.

One idea that should be questioned is why the Court decided to take up this case in the first place. If it is so obvious to the Court that the Plaintiffs did not have proper standing, and wanted to overturn the case on this issue rather than on the merits, why did the Court hear oral argument? The Court could have merely issued a brief denying the case for lack of standing, and reversed the Fifth Circuit’s holding without expending judicial resources on oral argument. Instead, it appears the Court went forward with oral argument in order to leave a metaphorical trail of breadcrumbs for future potential anti-abortion groups who want to try to bring this case again. In a way, the Court is providing tips to future plaintiffs on how to properly bring this case again, and win.

First, the justices posed questions to FDA attorney Solicitor General Elizabeth Prelogar about who an ideal plaintiff with legitimate standing for this case might be.49Id. at 6. In fact, after General Prelogar’s opening statements, the first question asked was who might have standing to challenge these FDA actions.50Id. By posing these questions, the Court is attempting to signal to anti-abortion groups exactly what kind of plaintiffs they would need in the future to properly bring a similar case. To her credit, the Solicitor General refused to identify an ideal plaintiff, and instead reminded the Court how important it is to comply with Article III standing principles.51Id. at 7.

Second, Justices Alito and Thomas themselves brought up the Comstock Act.52Id. at 26-27. Neither party addressed it until the Justices prompted the matter.53See Transcript of Oral Argument, supra note 31. If enforced, this Act would allow a willing president to put abortion providers in jail without any congressional action. Because the Justices themselves broached the Comstock Act, the most powerful Court in the country is providing merit and validation to any anti-abortion group who believes that the Comstock Act should ban the mailing of mifepristone, further encouraging restrictions on abortion access.   

IV. Conclusion

While the Court seems prepared to dismiss FDA v. Alliance for Hippocratic Medicine for lack of standing, this case should not be viewed as the finale to litigation over access to abortion medication. A willing future president could decide to enforce the Comstock Act, which would make the mailing of mifepristone illegal. Because the Justices indicated that there are other ways to properly bring this case, this case should not be viewed as the Supreme Court putting a hard stop to litigation on this topic. It should instead be viewed as a window into future arguments for further restrictions on abortion access.  


Cover Photo by Christine Sandu on Unsplash

Author

  • Cecilia received her bachelor’s degree in psychology from the University of Florida. Now in her final year of law school, she serves as the Managing Editor for Volume 93 of the University of Cincinnati Law Review.

References

  • 1
    FDA v. Alliance for Hippocratic Med., 602 U.S. No. 23-235 (2024).
  • 2
    Id.
  • 3
    Roe v. Wade, 410 U.S. 113, 153 (1973).
  • 4
    Id. at 164.
  • 5
    Id. at 163.
  • 6
    Id.
  • 7
    Id.
  • 8
    Id.
  • 9
    See Planned Parenthood v. Casey, 505 U.S. 833 (1992).
  • 10
    Id. at 954.
  • 11
    Id. at 895.
  • 12
    Id.
  • 13
    Id. at 954.
  • 14
    See Dobbs v. Jackson Women’s Health Org., 597 U.S. 215 (2022).
  • 15
    Id. at 292.
  • 16
    Id. at 301.
  • 17
    Id. at 292.
  • 18
    See Petition for Writ of Certiorari, U.S. Food and Drug Admin. v. All. for Hippocratic Med., 144 S. Ct. 537 (2023) (No. 23-10362).
  • 19
    Id. at 2.
  • 20
    Id.
  • 21
    Refusal to Perform Abortions, Policy Surveillance Program (2018), https://lawatlas.org/datasets/refusal-to-perform-abortions.
  • 22
    Jesse Wegman, An Anti-Abortion Case Too Far Fetched for the Supreme Court, N.Y. Times (Mar. 26, 2024), https://www.nytimes.com/live/2024/03/26/opinion/thepoint/abortion-mifepristone-supreme-court?smid=url-share.
  • 23
    Id.
  • 24
    Petition for Writ of Certiorari, supra note 16.
  • 25
    See id. at 21-22.
  • 26
    Id. at 25.
  • 27
    Eve Espey, Tiffany Hailstorks, & Lisa Hofler, Understanding the Impacts of the Supreme Court Case FDA v Alliance for Hippocratic Medicine, J. of the Am. Medical Ass’n (Mar. 25, 2024), https://jamanetwork.com/journals/jama/fullarticle/2816816.
  • 28
    Id.
  • 29
    Id.
  • 30
    Id.
  • 31
    All. for Hippocratic Med. v. U.S. Food & Drug Admin., 78 F.4th 210 (5th Cir. 2023).
  • 32
    Id.
  • 33
    Transcript of Oral Argument, Food and Drug Admin. v. All. for Hippocratic Med., 144 S. Ct. 537 (2024) (No. 23-235).
  • 34
    Id. at 26, 47-49, 73-77.
  • 35
    U.S. Const. art. III, § 2, cl. 1.
  • 36
    See Transcript of Oral Argument, supra note 31, at 26, 47-49, 73-77 .
  • 37
    Id.
  • 38
    Fetal personhood is the idea that life starts at conception. This idea is outside the scope of this article, but more information can be found at Madeline Carlisle, Fetal Personhood Laws Are a New Frontier in the Battle Over Reproductive Rights, Time (June 28, 2022), https://time.com/6191886/fetal-personhood-laws-roe-abortion/.
  • 39
    What are the Comstock Laws?, Planned Parenthood (May 12, 2023), https://www.plannedparenthood.org/blog/what-are-the-comstock-laws.
  • 40
    Id.
  • 41
    Id.
  • 42
    Id.
  • 43
    Id.
  • 44
    Memorandum Opinion for the General Counsel United States Postal Service on the Application of the Comstock Act to the Mailing of Prescription Drugs That Can Be Used for Abortions, Op. O.L.C. (Dec. 23, 2022), https://www.justice.gov/olc/opinion/file/1560596/dl.
  • 45
    Emily Bazelon, How a 150-Year-Old Law Against Lewdness Became a Key to the Abortion Fight, N.Y. Times (May 16, 2023), https://www.nytimes.com/2023/05/16/us/abortion-comstock-act.html.
  • 46
    Id.
  • 47
    Tina Smith, I Hope to Repeal an Arcane Law That Could Be Misused to Ban Abortion Nationwide, N.Y. Times (Apr. 2, 2024),https://www.nytimes.com/2024/04/02/opinion/comstock-act-abortion-repeal.html.
  • 48
    Transcript of Oral Argument, supra note 31, at 74.
  • 49
    Id. at 6.
  • 50
    Id.
  • 51
    Id. at 7.
  • 52
    Id. at 26-27.
  • 53
    See Transcript of Oral Argument, supra note 31.

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