The Battle over the Abortion Pill: The War on Abortion Continues

In the coming weeks, the United States District Court for the Northern District of Texas will rule on Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration: the case that has thrown into question the validity of the FDA’s 20-year-long approval of the drug mifepristone, the essential medication for U.S. abortion services, which now accounts for 54% of abortions nationally.

Although it is colloquially known as the ‘abortion pill,’ mifepristone is not prescribed alone, or solely for abortions. To medically induce an abortion, physicians prescribe a regime of two prescription medications: mifepristone and misoprostol. Mifepristone is an oral abortifacient used to induce an abortion up to the tenth week of pregnancy by blocking the hormone progesterone. Misoprostol, taken two days later, then empties the uterus of the fetus and uterine lining. To clarify, mifepristone is not the ‘morning-after-pill,’ an emergency contraceptive which prevents conception after unprotected sex, it is prescribed after conception to terminate pregnancy. As a steroid, mifepristone is also used to manage hormonal disorders, like Cushing’s syndrome, and noncancerous uterine growths.

The Alliance for Hippocratic Medicine, the plaintiff in this case, is an anti-abortion advocacy group uniting several socially conservative, Christian medical associations under the banner of “promot[ing] the fundamental principles of Hippocratic medicine” for “the vulnerable at the beginning and end of life.” The Alliance incorporated in August 2022, a mere four months before filing suit against the FDA to reverse the approval of mifepristone and remove the medicine from the market. The Alliance founded its suit on three legal controversies:

First, the plaintiffs allege that, in order to “fast-track” the approval of mifepristone, FDA wrongfully characterized pregnancy as a “Serious or Life-Threatening Illness” in violation of Subpart H of the Administrative Procedures Act (APA). Second, the Alliance reasons that the approval of mifepristone was irresponsible and without sufficient scientific evidence, especially regarding the medicine’s safety and efficacy for the pediatric population. Although the FDA has conceded they employed Subpart H in the approval of mifepristone, they argue that the medication was approved after considerable research four years after GenBioPro filed for market distribution. Furthermore, under current FDA regulations, there was no requirement to study an abortifacient’s effects on pediatric patients. Finally, the plaintiffs employ a very literal interpretation of the 19th Century Comstock Act to argue that the mailing of contraception, abortifacients, or other “indecent” materials, like mifepristone, is still a crime in 2023. In December 2022, however, the Department of Justice published that the mailing of mifepristone or misoprostol does not constitute a violation of the Comstock Act as long as the sender lacks the intent that the medication will be used unlawfully.

Evaluating the arguments of the Alliance for Hippocratic Medicine and the FDA is U.S. District Judge Matthew J. Kacsmaryk, infamous for his anti-Roe learnings and popularity with conservative advocacy groups “forum-shopping”: the practice of choosing to pursue one’s claim in a court that will treat the claim most favorably, whether that court has a sympathetic judge, is located within a specific state, or is part of the state or federal jurisdiction. Judge Kacsmaryk is the only presiding federal judge in Amarillo, Texas, where The Alliance incorporated and filed their claim.

If the United States District Court for the Northern District of Texas rules on the side of the Alliance, the FDA approval of mifepristone may be invalidated and the medication removed from the market temporarily. In a more extreme turn of events, however, the 150-year-old Comstock Law may be reinterpreted literally to block the distribution of medication abortion pills through the mail. This would end the ability to access abortion medicine through mail-order telehealth consultations: a method established during the COVID-19 pandemic that has since become common practice, due to its ease and discreteness. Contraceptives, like condoms and ‘birth control’ pills, and materials deemed “indecent” or “pornographic,” like sexual education pamphlets, could also be subject to this mail ban like they were in 1873. This limitation will not end at distribution through direct mail order, but extend to pharmacies, hospitals, clinics, and clinicians, ultimately limiting access to medical abortion for all people, even those in states where abortion is protected.

Despite this threat to abortion access nationwide, the Biden administration has been on the offensive in expanding access to abortion medication. In January 2023, the FDA first approved a process for brick-and-mortar pharmacies to achieve special certification for stocking and dispensing mifepristone. Prior to this amendment, mifepristone was only to be distributed in person by one’s primary physician. While pharmacies in over twelve states with near-to-total abortion bans and those maintaining in-person dispensation laws are exempt from the change, the updated guideline has sparked significant legal controversy.

No matter Judge Kacsmaryk’s ruling, an appeal is expected and many predict this controversial abortion case will end up being heard by the U.S. Supreme Court in the coming years. As the post-Roe landscape in the United States continues to shift, however, one thing is certain: Dobbs was only the beginning.