Abortion pill case built on faulty science
The Supreme Court heard arguments Tuesday in a case that never should have seen the inside of a courtroom: Alliance for Hippocratic Medicine v. Food and Drug Administration.
While the case moved through lower courts and had multiple rulings, the Supreme Court is focused on whether the plaintiffs — a group of anti-abortion rights physicians and organizations — have standing to challenge the FDA’s approval of mifepristone (one of two drugs used in most medication abortions in the country) and if the agency’s 2016 and 2021 amendments to expand access to the drug should be upheld.
Without legal standing, this case will not move forward. With standing, the entire drug regulatory system in the U.S. could be upended. And all of it hinges upon faulty science that calls the safety of mifepristone into question.
Mifepristone was initially developed as an abortifacient by French scientists and approved for use in France in 1988. In 2000, after more than a decade of use and research on safety and effectiveness in Europe and elsewhere, mifepristone was approved by the FDA for use in the U.S. In subsequent reviews of new evidence, the FDA modified the on-label use of mifepristone to ease access in 2016 and 2021 — increasing the approved use of mifepristone from seven to 10 weeks of pregnancy, expanding the cadre of providers that can prescribe the drug beyond physicians to include advanced practice clinicians and to allow for mailing of pills (rather than requiring in-person dispensing). These decisions were based on comprehensive reviews of scientific literature.
The plaintiffs in the Supreme Court case, however, are using discredited science in an attempt to revoke FDA approval of mifepristone. Despite decades of rigorous scientific data from over 100 studies demonstrating the safety and effectiveness of mifepristone, and nearly a quarter century of widespread use in the U.S., the plaintiffs claim that their evidence suggests otherwise — relying on just a handful of outlier papers that question the safety of medication abortion.
As epidemiologists, we joined with hundreds of other scientific community members to voice concerns about the data cited in the case. In February, two of the most heavily referenced studies in the plaintiff ’s argument (along with one additional study cited in the case) were retracted from the scientific journal Health Services Research and Managerial Epidemiology. Retractions are rare and only occur after careful external review demonstrating serious concerns such as lack of scientific rigor, conflicts of interest or falsification of data. In this case, the retracted studies presented spurious and unfounded conclusions about the safety of mifepristone based on an inappropriate study design.
Currently, for someone who wants to end their pregnancy with pills (rather than a procedure), there are two main medication regimens recommended by the World Health Organization and other clinical bodies: The combined regimen, which uses mifepristone followed by misoprostol, or the misoprostol-only regimen. In the U.S., only the combined regimen has FDA approval. While misoprostol-only can be offered through clinicians’ standard off-label prescribing authority, nearly all medication abortion prescriptions in the U.S. use the combined regimen.
What makes this case critical in the fight for reproductive health care access is, that if the court sides with the plaintiffs, the most commonly used drug in the country for medication abortions goes away or is even further restricted.
Multiple decades of clinical and epidemiologic data on the use of mifepristone demonstrate its robust safety profile. A Centers for Disease Control and Prevention report on the nearly 6 million people who have used mifepristone showed extremely low rates of infection, blood transfusion and risk of death. These low safety event risks are concordant with findings of a 2022 Cochrane Review of medication abortion safety and effectiveness.
Mifepristone is one of the most examined medications on the market in the U.S. In the 24 years since the FDA granted its original approval of mifepristone, the agency has reviewed the drug no fewer than four times, reaching the same clear and fullthroated conclusion: Mifepristone is safe and effective.
Looking at the data, there is only one conclusion we can draw — medication abortion, with mifepristone and/ or misoprostol, is safe, effective and a critical part of reproductive health care.
False claims driven by political viewpoints not grounded in science have landed this case at the Supreme Court, with dangerous implications that could upend abortion care and all medication development and regulation in the U.S. We hope that as the justices consider the case, science will prevail, facts will outweigh politics and FDA approval of mifepristone will remain intact.