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The Case Against Mifepristone

Anshumi Jhaveri

Edited by Saniya Koppikar, Jia Lin, and Vedanth Ramabhadran


The fate of a commonly used abortion pill known as Mifepristone is again before the Supreme Court of the United States, more than a year and a half after it said it would leave the decision to the states. Mifepristone is a medication that has been at the forefront of legal controversies and battles in the past year, but what many don’t know is that mifepristone has been through many legal hurdles over the years. French researchers developed mifepristone in the 1980s as a form of abortion care to be taken alongside misoprostol, another abortion medication. Despite opposition to mifepristone from anti-abortion activists, France approved the use of mifepristone in 1988. However, mifepristone usage in the United States was much more complicated. The Federal Drug Administration banned mifepristone importation in 1989 [1]. This would lead to the first battle in the courts regarding abortion medication in the United States. 

An American woman bringing mifepristone from the United Kingdom was stopped by US Customs in 1992. Although she lost her legal battle, her case brought mifepristone into the national spotlight and jump-started the movement to overturn the FDA ban [1]. After eight years of work by health professionals and advocates, mifepristone was finally approved for medication abortion in the year 2000. It has become a commonly used medication over the past two decades. As of 2020, medication abortion accounted for over half of all abortions in the United States, and this number is only growing as access to many abortion services continues to be impaired nationwide [2]. Despite widespread acceptance of mifepristone as a safe medication, there are imminent threats to nationwide access to the drug due to new legal battles. As reproductive coercion and control are coming to the forefront of our nation’s legal and political landscape, cases such as Alliance for Hippocratic Medicine v. FDA are trying to force the FDA to remove mifepristone’s approval. Mifepristone has demonstrated safety and effectiveness, making it an indispensable medication for women’s reproductive health. Its continued accessibility to the general public is essential to ensure women’s reproductive autonomy and promote overall public health and well-being. 

While there have always been challenges to medication abortion, they became especially apparent after the overturning of Roe v. Wade (1973) in 2022, which dealt reproductive rights a massive blow by ending federal protections for the right to an abortion. Roe v. Wade (1973) was the original case that granted a national right to an abortion. Dobbs v. Jackson (2022) granted states the right to ban abortion entirely, allowing potential attacks on all forms of reproductive healthcare, including medication abortion. This has further exacerbated current inequities within access to reproductive healthcare, as women of reproductive age with incomes below the federal poverty level face many barriers to not only contraceptive use but also abortion methods [3]. As a result, low-income women have a much higher rate of unintended pregnancy, which inevitably leads to a greater need for abortion. Before Roe fell, many of these women were insured by Medicaid, which allowed lower-income women of reproductive age to have access to primary and gynecological care before pregnancy [3]. In 40 states across the nation, Medicaid also expanded access to abortion services due to Roe, including medication abortion such as mifepristone and misoprostol. However, since Dobbs went into effect, access under Medicaid for low-income women varies based upon the state and their respective bans on reproductive healthcare. Many women who have unplanned pregnancies are not able to obtain an abortion, resulting in those pregnancies being carried to term. This disproportionately affects lower-income families and marginalized racial and ethnic groups. 

That said, the fall of Roe has led to innovation in policymaking and the healthcare system. Telemedicine for abortion services has become a popular option, along with mail-in abortion pills such as mifepristone and misoprostol, which can safely be taken at home. One of the most recent and most significant developments is the availability of over-the-counter abortion medication in stores such as Walgreens and CVS. Walgreens has stated that it will be rolling out mifepristone dispensing in New York, Pennsylvania, Massachusetts, California, and Illinois with intentions to expand access to all states where permissible [4]. CVS plans to dispense the medication in Massachusetts and Rhode Island and has similar intentions to expand access to other legal states [4]. Previously, people had to pick up medication abortion at their health-care providers. With drug stores such as Walgreens and CVS being certified to sell mifepristone, more people will be able to access the abortion medication they need. While included states are quite pro-choice, people in states that are conservative regarding reproductive healthcare can safely get the medication mailed from CVS and Walgreens, further expanding access for those in need. 

The Alliance for Hippocratic Medicine v. FDA case, which has taken the country by storm, may end this expansion. Anti-abortion activists in Texas filed this lawsuit against the Food and Drug Administration and the U.S. Health and Human Services in November 2022, challenging the initial approval of mifepristone and recent actions to further expand access to the drug [5]. If the lawsuit ultimately succeeds, access to medication abortion would end, even in states where abortion rights are protected. After Dobbs went into effect, The Alliance for Hippocratic Medicine, along with other anti-abortion groups, challenged the FDA’s approval of mifepristone, “claiming inadequate consideration of the evidence” back in 2000 [6]. Mifepristone has been documented as an incredibly safe drug—millions of people have safely used the medication, and expansive research backs this claim. However, a federal district court judge sided with the plaintiffs in April 2023, suspending the FDA’s approval of mifepristone [6] [7]. After a hearing in August 2023, the US Court of Appeals for the 5th Circuit partially upheld this decision, maintaining the original approval by the FDA in 2000 but striking down the changes made in 2016 to increase access to the drug, also known as the Risk Evaluation and Mitigation Strategies [6]. The U.S. Supreme Court has granted review and announced that it will be hearing oral arguments on March 26, 2024. 

If the Supreme Court sides with the plaintiffs, not only will access to medication abortion effectively end, but the country’s maternal mortality crisis will worsen. Mifepristone is used to treat ectopic pregnancies, miscarriages, and other various health conditions that do not have to do with getting an abortion [8]. In addition to further worsening the already critical issue of maternal mortality, the Supreme Court upholding the Fifth Circuit's ruling will set a precedent for the FDA’s authority over the approval process regarding other medications. This can set the dangerous precedent of turning to the law and courts for answers regarding scientific methods rather than doctors, scientists, researchers, and healthcare professionals who are genuinely qualified to make these decisions. The Supreme Court's ruling on this case is of interest to many, as an audit by the Government Accountability Office in 2008 found that the FDA’s approval of mifepristone was consistent with the approval of many other drugs [9]. 

The case, which will be the first time the Supreme Court has returned to the issue of abortion since it overturned Roe v. Wade, could have catastrophic healthcare impacts for millions. The Justice Department has urged the Supreme Court to reverse the lower rulings, but what will happen in this case is quite unpredictable. The Supreme Court’s current makeup leans conservative, with a 6-3 majority. 5 Justices voted to overturn Roe v. Wade, with Chief Justice Roberts writing his concurrence on how Mississippi specifically should be allowed to make its own abortion restrictions while simultaneously supporting the conflicting federal precedent in place under Roe. In simple terms, Chief Justice Roberts’s concurrence advocates for two conflicting things at the same time. It’s unclear how the Supreme Court will rule, but it is evident that the three liberal Supreme Court Justices will not be ruling in favor of the plaintiffs, as they have openly spoken about the dangers of prohibiting access to reproductive healthcare. What is up for discussion is how the six conservative Justices will rule and what will be used as their reasoning for either argument. The Alliance for Hippocratic Medicine claims that the FDA exceeded its regulatory power in making the drug more accessible. In contrast, the government argues that mifepristone has been deemed safe and effective for almost 25 years and that the FDA should continue to approve medications independently [10]. Ultimately, this is an incredibly high-stakes decision that the nation is awaiting, as it will set a precedent for whether anyone with an issue with a particular medication can challenge its approval and usage. The fate of reproductive rights also hangs in the balance, as mifepristone is currently one of the only ways people in states where abortion is illegal can get an abortion. The facts remain, however, that mifepristone has been proven safe time and time again, and it will be abundantly clear that this is not about science if the Court chooses to uphold the ruling of the Fifth Circuit.

 

[1] Reproductive Health Access Project, The History of Mifepristone, Reproductive Health Access Project (2023), https://www.reproductiveaccess.org/2023/04/history-of-mifepristone/ (last visited Mar 19, 2024).

[2] Medication Abortion Now Accounts for More Than Half of All US Abortions | Guttmacher Institute, (2022), https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions (last visited Mar 19, 2024).

[3] S. Marie Harvey, Annie E. Larson & Jocelyn T. Warren, The Dobbs Decision — Exacerbating U.S. Health Inequity, 388 N Engl J Med 1444 (2023), http://www.nejm.org/doi/10.1056/NEJMp2216698 (last visited Mar 19, 2024).

[4] Mifepristone abortion pills to be carried at CVS, Walgreens. Here’s what could happen next, USA TODAY, https://www.usatoday.com/story/news/nation/2024/03/06/cvs-walgreens-sell-mifepristone-will-other-pharmacies/72841441007/ (last visited Mar 19, 2024).

[5] Alliance for Hippocratic Medicine v. FDA, Center for Reproductive Rights, https://reproductiverights.org/case/alliance-for-hippocratic-medicine-v-fda/ (last visited Mar 19, 2024).

[6] Food and Drug Administration v. Alliance for Hippocratic Medicine, Oyez, https://www.oyez.org/cases/2023/23-235 (last visited Mar 19, 2024).

[9] Food and Drug Administration, Approval and Oversight of the Drug Mifeprex , (2008), https://www.gao.gov/assets/gao-08-751.pdf.

[10] Nina Totenberg & Annie Gersh, Supreme Court to Hear Abortion Pill Case, NPR, Dec. 13, 2023, https://www.npr.org/2023/12/13/1218332935/mifepristone-abortion-pill-supreme-court (last visited Mar 19, 2024).

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