By Bethany Jewison*

While many people in the United States are still reeling from the Dobbs decision, another blow could soon be dealt to abortion and reproductive health access. Several anti-abortion organizations have sued to repeal the FDA’s approval of an important abortion drug, mifepristone.^[1] The case is being heard in a Texas court by a federal judge who was appointed by Donald Trump.^[2] If the plaintiffs prevail, the drug would have to be taken off the market.^[3]

What is Mifepristone?      

Mifepristone is a drug which is used in conjunction with another medication (misoprostol) to induce an abortion or taken in the wake of a miscarriage.^[4] This type of abortion is known as a medication abortion which is more common today than a surgical abortion.^[5] Medications such as mifepristone have extended access to abortions because they are more easily administered to people seeking an abortion who do not have access to an abortion clinic.^[6] These medications have only become more vital to reproductive access in the wake of Dobbs, because clinics in states where abortion has remained legal are dealing with an influx of out-of-state patients.^[7] Mifepristone and misoprostol together are the “gold standard” method of abortion that can be used up until the tenth week of pregnancy.^[8]

The Lawsuit

The plaintiffs in this lawsuit are four healthcare organizations led by the Alliance for Hippocratic Medicine, an anti-abortion association of doctors, as well as four doctors suing in their individual capacities.^[9] The plaintiffs argue that the drug should not have been granted FDA approval because of the medical risks associated with it.^[10] They have also challenged the initial approval process that the drug went through over twenty years ago and the lack of restrictions on how the drug can be distributed.^[11] For example, as telehealth appointments have become more common,^[12] patients seeking mifepristone and who live in a state where abortion is legal can receive the drug after consulting with a provider remotely.^[13]

The complaint alleges, in part, that the FDA wrongfully accelerated its approval process under 21 C.F.R. § 314, Subpart H (Subpart H).^[14] Plaintiffs claim that the FDA did not have the legal authority to give expedited approval because this regulation only allows a sped-up approval process for drugs that treat “serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments.”^[15] Astonishingly, the plaintiffs claim pregnancy is not a serious or life-threatening condition because “following delivery, almost all women return to a normal routine without disability.”^[16] This statement obscures the fact that approximately 900 women in the United States die each year as a result of pregnancy or delivery complications.^[17]

While mortality and long-term disability rates could be considered relatively low in the U.S. compared to history or other countries, Black and Latinx people are significantly more likely to die as a result of pregnancy or childbirth than white people in the U.S.^[18] Also, these data were measured when abortion access was still federally protected.^[19] Less abortion access and therefore more demand for OB-GYN services and more strain on hospital resources may raise maternal mortality rates in the U.S. Furthermore, approximately one out of every seven women who give birth in the United States will experience postpartum depression,^[20], which is certainly disruptive to their lives. Perhaps the most shocking assertion in this excerpt of the complaint is the assumption that being forced into raising an unwanted child could constitute returning to a “normal routine.”^[21]

Is There Hope for the Future of Reproductive Healthcare?

If the judge in this case rules in favor of the anti-abortion plaintiffs, the results will be disastrous for people seeking abortions, even those in states where it is legal.^[22] Wait times for an abortion would likely become even longer as clinics would struggle even more than they already do to keep up with demand. Also, more women would probably have to endure the difficult and intrusive surgical abortion procedure without the availability of mifepristone.

While anti-abortion groups continue to launch attacks on the rights of people to make decisions about their reproductive health, pro-choice advocates have remained determined in their fight to protect these rights. This month, 20 governors of states where abortion has remained legal have formed a coalition called the Reproductive Freedom Alliance.^[23] Their aim is to work collaboratively to continue protecting the rights of citizens in their states to choose, as well as to provide safe harbor and care for those coming from states where abortion is illegal seeking an abortion.^[24] As of now, it is unclear exactly what that will mean or look like in practice, but according to the president of Planned Parenthood, this unified front is needed “now more than ever.”^[25]

* Staff Member; J.D. Candidate, UMN Law School – Class of 2024

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^[1] Complaint, Alliance for Hippocratic Med. v. U.S. Food and Drug Admin., No. 2:22-CV-00223-Z (N.D.Tex. Nov. 18, 2022), available at https://adfmedialegalfiles.blob.core.windows.net/files/AllianceForHippocraticMedicineComplaint.pdf.

^[2] Sarah McCammon, A Trump-Appointed Texas Judge Could Force a Major Abortion Pill Off the Market, NPR (Feb. 10, 2023) https://www.npr.org/2023/02/01/1153593174/mifepristone-abortion-pill-federal-texas-lawsuit-restrict-access-nationwide.

^[3] Id.

^[4] Haley Weiss, The Most Common Abortion Method Is in Danger in Every State, Time (Feb. 15, 2023) https://time.com/6255625/abortion-pills-mifepristone-texas-lawsuit/.

^[5] Id.

^[6] Id.

^[7] Gianna Mellilo, These sSates Saw the Biggest Increase in Abortions After Roe’s Overturn, The Hill (Oct. 31, 2022) https://thehill.com/changing-america/respect/accessibility/3712474-these-states-saw-the-biggest-increase-in-abortions-after-roes-overturn/.

^[8] Weiss, supra note 4.

^[9] Complaint at 8-9, Alliance for Hippocratic Med. v. U.S. Food and Drug Admin., No. 2:22-CV-00223-Z (N.D.Tex. Nov. 18, 2022), available at https://adfmedialegalfiles.blob.core.windows.net/files/AllianceForHippocraticMedicineComplaint.pdf.

^[10]See id.

^[11] Id. at 2.

^[12] Government Accountability Office, Telehealth in the Pandemic—How Has It Changed Health Care Delivery in Medicaid and Medicare?, GAO (Sept. 29, 2022) https://www.gao.gov/blog/telehealth-pandemic-how-has-it-changed-health-care-delivery-medicaid-and-medicare.

^[13] Complaint at 83, Alliance for Hippocratic Med. v. U.S. Food and Drug Admin., No. 2:22-CV-00223-Z, at 5 (N.D.Tex. Nov. 18, 2022), available at https://adfmedialegalfiles.blob.core.windows.net/files/AllianceForHippocraticMedicineComplaint.pdf.

^[14] Id. at 15.

^[15] Id.

^[16] Id.

^[17] Donna L. Hoyert, Maternal Mortality Rates in the United States, 2020, CDC (2020), https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2020/maternal-mortality-rates-2020.htm.

^[18] Id.

^[19] Id.

^[20] Saba Mughal, Postpartum Depression, CDC (Oct. 7, 2022) https://www.ncbi.nlm.nih.gov/books/NBK519070/.

^[21] Complaint at 15, Alliance for Hippocratic Med. v. U.S. Food and Drug Admin., No. 2:22-CV-00223-Z, at 15 (N.D.Tex. Nov. 18, 2022), available at https://adfmedialegalfiles.blob.core.windows.net/files/AllianceForHippocraticMedicineComplaint.pdf.

^[22] Weiss, supra note 4.

^[23] Christine Fernando, 20 Democratic Governors Form Abortion-Rights Coalition Amid ‘Unprecedented Assault’, USA Today (Feb. 21, 2023) https://www.usatoday.com/story/news/nation/2023/02/21/reproductive-freedom-alliance-democrat-governors-abortion-rights/11312622002/.

^[24]Id.

^[25]Id.