Access to Mifepristone Could Hinge on Whether Pregnancy is "Illness"—What History Says

In November 2022, a group of physicians filed a lawsuit against the U.S. Federal Drug Administration (FDA) seeking to revoke their approval of mifepristone, one of the medications in the abortion regimen that accounts for more than half of abortions in the U.S.

The plaintiffs argue that the FDA was remiss in approving the drug in 2000 through its accelerated approval process. This rushed process, they assert, did not allow sufficient time to investigate the side effects of the drug, side effects that have harmed women’s health in the two decades since its approval. Moreover, the plaintiffs continue, mifepristone should never have been eligible for the accelerated process, which is reserved for drugs that treat “serious or life-threatening illnesses,” because “pregnancy is not an illness.”^[1]

This latter part of the lawsuit’s argument—whether or not pregnancy should be classified as an illness—is a linchpin of the plaintiffs’ case. As an historian of ancient Greek and Roman medicine, I’m keenly interested in the historical precedent of this question. Especially since the plaintiffs, medical professionals who call themselves the Alliance for Hippocratic Medicine, self-consciously position themselves as heirs of a long-standing medical tradition. Their name suggests that their stance aligns with medical precedent, but does it?

In their complaint, the mifepristone plaintiffs define “illness” as a condition that affects day-to-day functioning; a condition that, if left untreated, will progress from a less to a more serious condition; or a condition that threatens one’s survival. HIV, tuberculosis, and cancer, the plaintiffs argue, meet these criteria. Pregnancy, on the contrary, merely involves “normal physiological processes.”^[2]

The U.S. District Judge Matthew J. Kacsmaryk who heard the case in early April 2023 agreed with the plaintiffs. Although Kacsmaryk acknowledged that complications sometimes arise from pregnancy, he ultimately concluded that “pregnancy is a normal physiological state most women experience one or more times during their childbearing years — a natural process essential to perpetuating human life.”^[3]

And in the May 2023 appeals court hearing, Judge Ho—one of the three judges hearing the appeal—seemed to indicate his agreement when he asked: “We just celebrated Mother’s Day. Were we celebrating illness?”^[4] As we wait for the determination of the appellate court, it’s clear that their ruling will hinge on whether or not to categorize pregnancy as an illness.

When we turn to ancient Greek and Roman medicine, we find wide acknowledgment that women’s health takes a sharp turn downward when they become pregnant. The 6th-century medical writer Aëtius of Amida, for example, detailed numerous symptoms of pregnancy that affected women’s health. Beginning around forty days after conception, he explains, pregnant people experienced an upset stomach, nausea, and aversion to food that, in turn, can cause pain, vomiting, and feelings of anxiety.^[5] Moreover, dozens of Hippocratic case histories documented additional health risks. For example, one case described the experiences of a woman who hemorrhaged in the tenth month of her pregnancy and again shortly before childbirth.^[6] In another case, the sister of Harpalides experienced swelling around her ankles and feet in her fourth or fifth month of pregnancy, as well as breathing troubles that lasted for nearly two months of her pregnancy.^[7] Many ancient medical case histories document pregnancies that resulted in death. One case describes the debilitating nausea, heartburn, lack of appetite, weakness, and fever that seized the wife of Antimachus about fifty days into her pregnancy. Soon thereafter, the case reports, “She died in the middle of the night.”^[8]