GOOD ARGUMENTS, BAD STANDING: THE STATUS OF MEDICATION ABORTION IN THE UNITED STATES

I. HISTORICAL AND LEGISLATIVE BACKGROUND

Food and Drug Administration v. Alliance for Hippocratic Medicine is best understood after considering several other relevant cases and legislation. Below, I briefly explain the Comstock Act and Subpart H of the CFR’s Title 21, which are central to understanding the June 2024 decision. Afterwards, I give a broad overview of the historical background of the case, namely the process of medical abortion and the FDA’s history of dealing with citizen petitions against mifepristone.

A. The Comstock Act and 21 CFR §§ 314 Subpart H

The Comstock Act, passed in 1873, banned various materials deemed “obscene or indecent” from being disseminated in the United States, specifically by selling or mailing such offensive materials. The current revised version of the Act includes a prohibition against the mailing of anything designed to cause abortion. In its extreme, the Act can be viewed as an outright ban of abortion, or, at the very least, a ban against circulating abortion-related materials across state lines. 

Despite its clearly worded language seemingly banning the dissemination of abortion medication, the Comstock Act has never been used to ban such drugs. Classically, the Act is viewed as strictly an obscenity statute, concerned with the prohibition of materials on grounds of decency. Banning abortion-related materials on ethical grounds, aside from issues of lewdness and vulgarity, has been seen as being outside of the Comstock Act’s legal purview. 

B. 21 CFR § 314.500 Subpart H 

Subpart H— “Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses,” allows expedited approval for the circulation of “new drug products that have been studied for their safety treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments.” The drug that the FDA plaintiffs sought to revoke access to, mifepristone, was approved in 2000 under this subpart, raising questions about what serious illness the FDA viewed the abortion drug as treating that permitted the usage of Subpart H to hasten its approval.

C. Medical Abortion and Dobbs

The Association of American Medical Colleges (AAMC) describes medication abortion as a two-step process. First, a mifepristone pill is administered to the pregnant woman, terminating her pregnancy. 24 to 48 hours after her consumption of mifepristone, the woman is given misoprostol, a series of four pills inducing contractions that expel the fetus from the uterus. Some doctors prescribe a second round of misoprostol pills to be taken four hours after the first round in longer-lasting pregnancies.

With abortion no longer recognized as a constitutional right after the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, pregnant women seeking to terminate their pregnancies are increasingly reliant on medication abortion, in no small part for its ability to be mailed across the country to states restricting or banning abortion. This shift makes the Alliance for Hippocratic Medicine’s attempt to completely block mifepristone access immensely consequential.

D. Mifepristone Approval and Citizen Petitions

The story of mifepristone’s FDA approval provides necessary legal precedent to wholly flesh out the context of Alliance for Hippocratic Medicine. The contested abortion medication was approved in 2000 under the brand name Mifeprex using Title 21 Subpart H of the CFR. The 2000 approval came with several restrictions surrounding Mifeprex’s use: it could only be used on pregnancies within 7 weeks when prescribed by a doctor having three in-person visits with a prospective patient. The prescribing doctor would be required to supervise the usage of the drug, reporting instances of hospitalizations, blood transfusions, and other severe side effects from its usage.

In 2016, the FDA significantly loosened restrictions governing Mifeprex. The drug could now be used in pregnancies up to 10 weeks, prescription privileges were extended to healthcare providers other than doctors, such as nurse practitioners, and the visit requirement was lowered to just one in-person visit. Additionally, only fatalities linked to Mifeprex usage had to be reported by prescribers; wide-ranging harmful effects stemming from the drug no longer legally necessitated such a report.

A 2019 amendment to Mifeprex legislation approved generic mifepristone tablets, albeit while being subject to the same restrictions as its brand-name counterpart. In 2021, the in-person requirement governing both brand-name and generic mifepristone was removed altogether. In spite of the 2022 Dobbs decision, mifepristone usage surged nationwide, with a reported 63% of abortions—a whopping 642,700 cases—being performed medically.

This dramatic rise in mifepristone usage did not occur uncontested. Several groups have aired their grievances to the FDA over the span of mifepristone’s decades-long span of approval, but their pleas have consistently been denied. In 2002, three pro-life associations submitted a joint citizen petition to the FDA, asking for a full revocation of mifepristone approval, a request denied by the FDA. Another citizen petition was filed in 2019 by two pro-life medical associations, seeking to remove the 2016 modified mifepristone regulation, a request also denied by the FDA. FDA v. Alliance for Hippocratic Medicine occurs precisely within the framework of a burgeoning national availability of mifepristone and a series of failed FDA appeals to limit its access.

II. FDA V. ALLIANCE FOR HIPPOCRATIC MEDICINE

In 2022, four pro-life medical associations and several individual doctors—the Alliance for Hippocratic Medicine—jointly sued the FDA in the Northern District of Texas for purported injuries stemming from the FDA’s mifepristone approval, aiming to force an injunction requiring the removal of the abortion drug from the market. Additionally, the plaintiffs claimed the abortion medication’s approval and distribution was in direct violation of the Comstock Act and Subpart H, providing another reason to permit a court injunction against the medication.

A. Ruling and Rationale of the District Court

In the District Court case, Judge Matthew Kacsmaryk agreed with the plaintiffs’ claims of mifepristone approval contradicting the Comstock Act and Subpart H. Judge Kacsmaryk determined that the FDA’s December 2021 amendment removing the in-person dispensation requirement directly violated the Comstock Act’s clear prohibition against mailing abortion materials. Violations of Subpart H were found to be even more blatant by the District Court than those of the Comstock Act. Judge Kacsmaryk stressed that pregnancies are not “serious or life-threatening illnesses” that would warrant Subpart H approval for drugs, such as mifepristone, to treat such illnesses by medication abortion. Additionally, the judge noted the subpart’s stipulation that expedited prescription approval was allowed only in the absence of less effective “existing treatments.” Alternatives to medication abortion, namely surgical abortion, were viewed by the court as “a statistically far safer procedure” than mifepristone. Kacsmaryk thus viewed Subpart H as “doubly foreclos[ing] FDA’s approval of mifepristone”: the drug was neither approved to primarily treat severe illnesses nor proven to be a superior alternative to existing abortion methods. The District Court ultimately enjoined FDA’s approval of mifepristone, essentially removing it from the drug market.

B. Appellate Status upon Reaching the Supreme Court

By the time the Supreme Court heard the case in March of 2024, FDA had moderate success in appealing the District Court ruling. The Fifth Circuit Court of Appeals granted a partial stay on Judge Kacsmaryk’s ruling, undoing the removal of FDA’s 2000 and 2019 mifepristone regulations but retaining the enjoinment of its 2016 and 2021 actions. In other words, following the Circuit Court’s decision but before the Supreme Court’s ruling, mifepristone and Mifeprex were approved to be on the drug market, but only under the original regulatory framework instated in 2000: within 7 weeks of pregnancy, after three in-person doctor visits, and with a requirement to report all adverse abortion-medication effects to the FDA. 

C. Article III Standing and the Merits

The Supreme Court reversed the appellate court’s decision, resulting in the reinstatement of all FDA mifepristone regulatory actions, including those passed in 2016 and 2021. The reason for their decision was not based on the merits of the case, which the court purposely did not consider in its judgement, but rather stemmed from technical issues of standing under Article III of the Constitution. Article III standing requires plaintiffs suing the United States to prove that they suffered harm directly attributable to governmental actions that can be redressed through judicial intervention. In order to establish standing in this case, the plaintiffs had to prove they were injured by the “unlawful regulation (or lack of regulation) of someone else.” The Supreme Court found the plaintiffs’ attempts to establish causality as overly attenuated, speculative, and unpredictable, making their claims of injury and FDA wrongdoing irrelevant to the Court’s ultimate judgment.

Although the court did not formally evaluate the Alliance for Hippocratic Medicine’s claims, they did address them. Justice Brett Kavanaugh’s majority opinion described the viewpoints of the plaintiffs as “sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used.” Had it not been for their lack of Article III standing, the plaintiffs might have found some success in reversing increasingly-lax mifepristone approval.

CONCLUSION

The possibility of the Supreme Court hearing a similar case—one with the legal merits of FDA v. Alliance for Hippocratic Medicine but without any Article III standing roadblocks—has not been lost on the legal community. This possibility seems even more likely in the wake of Loper Bright Enterprises v. Raimondo, the 2024 Supreme Court case overturning Chevron Doctrine, effectively reversing four decades of precedent granting deference to the legal interpretations of government agencies. Without the assumption of this “agency deference,” the FDA’s dubious applications of Subpart H and the Comstock Act, as noted by Judge Kacsymark, are more likely to be successfully challenged. The combination of prospective plaintiffs’ solid Article III standing with the Court’s increasingly critical view towards the FDA’s interpretation of the agency’s governing statutes could signal the abrupt cessation of mifepristone legality.

Conversely, there are clear signs that the ruling in FDA v. Alliance for Hippocratic Medicine could be indicative of momentum in the FDA’s favor, as seen in a pair of abortion-related cases. Moyle v. United States and Idaho v. United States were each dismissed on technicalities: both were deemed to be improvidently granted, and the merits of both cases, as in Alliance for Hippocratic Medicine, were not considered. While the outcome of future FDA suits where plaintiffs’ merits are considered is certainly up for debate, the continued dismissal of medical abortion-related cases on procedural grounds allows mifepristone approval to continue uncontested. This, combined with the FDA’s continued apathy towards citizen petitions against mifepristone, paints a picture of the future of mifepristone legislation where plaintiffs are perpetually unable to undo any of FDA’s regulatory actions. FDA v. Alliance for Hippocratic Medicine’s long-term impact on medication abortion has clearly yet to be seen, but it has the potential to shift the fate of nationwide medical abortion access in either direction.