I. Introduction

It is without contest that the issue of abortion sparks enormous controversy in the United States. Abortion was widely criminalized for over a century until 1973, when Roe v. Wade set the precedent that women were entitled to agency over their reproductive rights under the condition that the government retained the right to regulate abortion after a particular stage of pregnancy.¹Roe v. Wade and Supreme Court Abortion Cases, https://www.brennancenter.org. Since then, the controversy continues to be debated in political and social settings. In June of 2022, Dobbs v. Jackson Women’s Health Organization overruled Roe and another case that upheld its holding: Planned Parenthood of Southeastern Pennsylvania v. Casey. Dobbs held that abortion is indeed not a constitutional right, setting both the pro-choice and pro-life movements ablaze.²Dobbs v. Jackson Women’s Health Organization, No. 19-1392, 597 U.S. 215 (2022). Now, in a post-Roe state, pro-choice and pro-life movements remain incredibly vocal about their respective beliefs. In Dobbs’s wake, convoluted cases regarding personhood have shaken state legal systems, such as Brandy Bottone of Plano, Texas, claiming that she was permitted to drive in the High-Occupancy Vehicle lane on the highway as her fetus counted as a human person.³Vanessa Romo, Pregnant Woman Who Claimed Her Fetus Was an HOV Lane Passenger, https://www.npr.org. Another such case was decided in the Alabama Supreme Court, ruling that embryos are legally considered to be babies.⁴Kim Chandler, Alabama Hospital Puts Pause on IVF in Wake of Ruling, https://apnews.com. These rulings showcase the extent to which today’s legal system values the lives of unborn children more than the agency of women and families. For many people in America, this is a dark new reality filled with anger, fear, and uncertainty.

This is where the discussion of mifepristone, a widely used abortion drug, enters the discourse. The Dobbs decision revoked women’s reproductive agency on a federal and constitutional level, but on the state level, the debate is still alive and well. Sixteen states have outlawed abortion at conception or after six weeks, and only 26 states–excluding Washington, DC, Puerto Rico, and the U.S. Virgin Islands– retained their abortion legalization. The rest of the states have partial bans or the legislative debate over abortion is ongoing.⁵Carter Sherman, et al., Abortion Rights Across the US, https://www.theguardian.com. Mifepristone is a crucial aspect of current abortion accessibility, as it is a reliable option for people who live in states where abortion is legal, and for those who are able to travel to said states. Thus, mifepristone and any bioequivalents must be safeguarded by law if there is to be a semblance of bodily autonomy for women in this post-Roe United States.

II. Background on the Development of Mifepristone

Mifepristone is a pill that, when taken along with misoprostol, safely ends pregnancy; it is mainly effective within the first seven weeks of pregnancy.⁶Petition for a Writ of Certiorari, Alliance for Hippocratic Medicine v. Food and Drug Administration. Mifepristone was first developed in France in the 1960s. This was a time where contraceptive pills were being developed, and there was certainly negative backlash to the development of these drugs. Across the globe, religion was closely associated with access to abortion and contraception, causing those drugs to be criminalized by governments who feared upsetting major religious institutions, such as the Catholic Church. When the development of mifepristone was finalized in the 1980s, along with new legalization of birth control in Europe, women were able to reclaim agency over their lives and make their own decisions about their family planning and life trajectories. In the early stages of being tested for distribution, mifepristone proved to be an extremely effective means for having a safe and non-invasive abortion.⁷R. Alta Charo, A Political History of RU-486, 1991, https://www.ncbi.nlm.nih.gov.

While the use and distribution of mifepristone was approved in France in 1988, it was prohibited from being imported into the United States just the following year.⁸Reproductive Health Access Project, The History of Mifepristone, https://www.reproductiveaccess.org. This was fifteen years after Roe, so it did not take long for the drug to enter the spotlight of the American legal system as an option for abortion. President Bill Clinton authorized mifepristone to be a method of medicated abortion in 1993. After twelve years of reproductive activism, advocating for the approval of mifepristone for use in medicated abortion, those same activists’ dreams became a reality when the FDA approved mifepristone in September of 2000.⁹Ibid. Since then, mifepristone has continued to be a hot-topic for anti-abortion activists and a treasure for pro-choice activists.

III. The Evolution of FDA Regulations on Mifepristone

Mifepristone taken along with misoprostol, is an effective, safe, and prevalent method for medicated abortion.¹⁰Rachel K. Jones, et al., Medication Abortion Now Accounts for More than Half of All US Abortions, https://www.guttmacher.org. Since the FDA approved mifepristone, it has been used by 5.9 million people, from 2000 until the end of 2022. The vast majority of people who have taken this pill experience no adverse side effects, while the tiny fraction of people who did experience negative effects did not necessarily do so directly because of their consumption of mifepristone.¹¹Food and Drug Administration, Mifepristone U.S. Post-Marketing Adverse Events Summary through 12/31/2022, https://www.fda.gov. Potential adverse effects have included ectopic pregnancies, infections, blood loss, and hospitalization. Though, as I stated above, these side effects have not been directly caused by the patient’s consumption of mifepristone. When the FDA first approved mifepristone, they imposed regulations called “Subpart H.”¹²Petition for a Writ of Certiorari, Alliance for Hippocratic Medicine v. Food and Drug Administration. This classified the drug as “a new drug… that [has] been studied for [its] safety and effectiveness in treating serious or life-threatening illnesses.”¹³Laurie Sobel, et al., Legal Challenges to the FDA Approval of Medication, https://www.kff.org. The Subpart H regulation required for mifepristone to be picked up from the pharmacy and to be prescribed only by doctors with “special qualifications.”¹⁴Petition for a Writ of Certiorari, Alliance for Hippocratic Medicine v. Food and Drug Administration. Congress then established a new regulatory plan for FDA approved drugs still enduring testing and restrictions–this structure is called Risk Mitigation and Evaluation Strategy, or REMS. So, when the REMS framework was adopted in 2007, it made those drugs with Subpart H regulations–including mifepristone–subject to REMS, though the regulations themselves did not change.¹⁵Ibid.

In 2016, many restrictions placed upon mifepristone as a result of its REMS status were lifted. The FDA declared that people could take mifepristone when they were ten weeks pregnant instead of seven, it reduced the amount of times a person needed to consult with their doctor before being prescribed mifepristone, and other healthcare professionals such as nurse practitioners could now prescribe the drug. The FDA additionally required less reporting by physicians about any adverse effects people were experiencing from mifepristone, as it consistently saw safe and effective results from the drug over the fifteen years it was approved.¹⁶Ibid. This was a leap forward in terms of the FDA’s declaration of mifepristone as a safe drug, and for the widespread accessibility of the drug.

However, controversy ensued as a result of mifepristone’s REMS status during the COVID-19 pandemic. With its REMS status, delivery of mifepristone was prohibited–this caused people to face the risk of contracting COVID-19 to pick up their medication, or to find another way of ending their pregnancy.¹⁷Reproductive Health Access Project, supra note 8. Other drugs under REMS status were granted special permission from the FDA to be delivered during the pandemic to lessen exposure to COVID–mifepristone was not one of those drugs. The American Civil Liberties Union (ACLU) sued the FDA in the Spring of 2020, driving them to extend their special permission to Mifepristone. That July, the federal district court where the case was being argued granted a temporary injunction, ensuring that mifepristone would be able to be delivered to people with a prescription.¹⁸Ibid. In 2023, this injunction was made permanent and mifepristone could be delivered and used within the first ten weeks of pregnancy.¹⁹Ibid. The lifting of these regulations was a victory for reproductive activists and low-income communities who bore the brunt of the restrictions placed upon mifepristone during the pandemic.²⁰Reproductive Health Access Project, supra note 8, 17.

IV. Alliance for Hippocratic Medicine v. Food and Drug Administration

The FDA approval of mifepristone did not come without its consequences. Since then, the war between pro and anti choice sentiment in this country rages on, with mifepristone at the center of it. The case that has brought the most attention to this issue is the unprecedented case of Alliance for Hippocratic Medicine et al. v. Food and Drug Administration.²¹Petition for a Writ of Certiorari, Alliance for Hippocratic Medicine v. Food and Drug Administration. This case was filed in November of 2022 in the U.S. District Court for the North Texas Amarillo Division by the Alliance for Hippocratic Medicine, and other anti-abortion advocacy groups and a few individual physicians.²²Sobel, supra note 13. They sued the FDA for their original approval of mifepristone in 2000, the lifting of various restrictions in 2016, the creation of a generic version of mifepristone (Mifeprex) in 2019, the 2021 injunction allowing delivery of the drug, and the FDA’s striking down of previous petitions by the plaintiffs in 2016 and 2021.²³Petition for a Writ of Certiorari, Alliance for Hippocratic Medicine v. Food and Drug Administration. Their grounds for suit are that their approval of mifepristone was not within their authority, and that, based on the Comstock Act of 1873, they are barred from allowing the delivery of any drug that ends pregnancy. Additionally, the plaintiffs requested for the District Court to issue a preliminary order forcing the FDA to halt all distribution of mifepristone.²⁴Andrea Frey, et al., Understanding Standing with AHM v. FDA, https://www.reuters.com. This is the first time a court has been asked to reconsider the FDA’s previous approval of a drug, especially one that has such widespread and vetted use.²⁵Ibid.

The plaintiffs claim that the FDA has overstepped the bounds of their power by approving mifepristone. They claim that they have had patients who experienced adverse side effects after taking mifepristone, and that treating and educating them about the “risks” of medicated abortion takes time away from treating other patients they have.²⁶Ibid. Thus, they contend that the FDA is overstepping their reach and wrongly disrupting the work of the plaintiffs.²⁷Ibid.

The FDA asserted that the plaintiffs have suffered no injury; the FDA additionally warned against finding standing in the plaintiff’s case as setting this precedent could cause a slippery slope regarding the legality of other FDA approved drugs, and how physicians are supposed to view the adverse effects a drug may have. This case would additionally strongly undermine the FDA’s authority.²⁸Sobel, supra note 13, 22.

In April of 2023, the district court judge in Texas found for the plaintiffs, determining that the FDA wrongfully approved mifepristone. Following this ruling, a federal district court judge in Washington, DC issued a ruling that upheld the FDA’s approval of mifepristone. The Biden Administration jumped in, temporarily blocking any effects on the availability of mifepristone.²⁹Sarah Tibbits, Thomas Thai, Mifepristone: Where Things Stand in Legal Battle, https://www.lwv.org. The Fifth U.S. Circuit Court of Appeals then decided that the plaintiffs had standing to bring this case forward.³⁰Frey, supra note 24.

A contentious issue in this case is whether or not the plaintiffs have legal standing to sue the FDA for their actions. Legal standing is usually confirmed when the plaintiff demonstrates that they were injured, the defendant injured them, and the injury would be mended by the compensation or judicial act they are requesting.³¹Ibid. The plaintiffs assert that they have been harmed by the FDA because of a hypothetical situation where a patient who was prescribed mifepristone experienced adverse effects of the drug, and sought their medical care, taking time away from their treatment of other patients. The Fifth Circuit affirmed their statements, granting standing on the basis that the plaintiffs had valid reason to experience emotional turmoil from any complications that may arise from a patient suffering from adverse effects of mifepristone. Another reason for their standing determination was the organizational upheaval of modifying their research and spending more time treating patients who might suffer from complications of using the drug. The Fifth Circuit’s final point was that the plaintiffs were in the zone of interest because they are merely attempting to reassure their patients who are seeking safety in the procedures they endure.³²Ibid.

In reality, the plaintiffs are on uneven ground in their assertions of standing in this case. Doctors in the Alliance for Hippocratic Medicine do not provide abortion care to their patients, so they would not be prescribing mifepristone to anyone. This causes confusion about why a patient would seek out their care while experiencing adverse effects from mifepristone, if they did not prescribe it to this patient. There is no concrete evidence that suggests any of the doctors in the Alliance for Hippocratic Medicine have needed to provide emergency care to a patient in this position.³³National Women’s Law Center, FDA v. Alliance for Hippocratic Medicine, https://nwlc.org.

Notwithstanding this, the Fifth Circuit ruled that in the meantime, mifepristone could only be used within the first seven weeks of pregnancy instead of the first ten weeks, and it imposed restrictions similar to those imposed on the drug before 2016.³⁴Tibbitts & Thai, supra, note 29. The federal government sought for the Supreme Court to take action–as a response, the Court maintained the status quo, ensuring that mifepristone remains available for the time being. In August of 2023, the Fifth Circuit ruled against the plaintiff’s complaints, but they enforced past restrictions on mifepristone.³⁵Ibid. The FDA appealed to the Supreme Court, and the case was granted certiorari; oral arguments were heard on March 26, 2024.³⁶Center for Reproductive Rights, AHM v. FDA, https://reproductiverights.org.

V. Conclusion

This case wields the power to eradicate a safe and vetted FDA approved medication, limiting already curbed access to abortion post Dobbs. The current Supreme Court, who is about to decide the fate of this case, has not only a conservative majority, but a pro-life majority. Justices Thomas and Alito already fought against the Supreme Court ruling to temporarily maintain mifepristone’s status prior to the Fifth Circuit’s ruling–they are guaranteed to uphold that opinion when the time comes to decide the case.³⁷Tibbits & Thai, supra note 29, 34. If the Supreme Court affirms the Texas district court’s decision, medicated abortion will be outlawed nationwide.

Alliance for Hippocratic Medicine v. Food and Drug Administration is just one piece in the convoluted puzzle that is the American abortion debate. However, its outcome will have a fierce ripple effect on the whole country. The availability of mifepristone allows women living in states where abortion is illegal to travel and obtain the drug from a state where it is legal. This case shines a light on the long and grueling path the United States is on to taking back agency of women’s bodies on a federal level. Though that path may be long, I remain hopeful that success awaits at the end, but it will not come without devastating consequences to our country and our people.

Edited by Annie Cayer and Emma Morgan

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Notes from the Author