In April, we reported on the Alliance for Hippocratic Medicine (AHM) and other doctors suing the FDA over the abortion pill, mifepristone. In this report, we follow up on what has happened in the legal case since then, and what lies ahead.
After months of uncertainty, the Supreme Court finally announced on December 13 that it will hear FDA v. Alliance for Hippocratic Medicine next spring.
The AHM, a recently established group with ties to conservative and religious organizations represented by the same legal group involved in overturning Roe v. Wade, launched a lawsuit against the FDA challenging its 2000 approval of the drug mifepristone (Mifeprex), which is commonly used in medication abortion regimens as well as for miscarriage management. What started as a case in Amarillo, Texas will now be heard by the Supreme Court, according to the recent announcement.
Greer Donley, JD, a professor at the University of Pittsburgh School of Law in Pennsylvania, told MedPage Today that she wasn’t surprised the Supreme Court accepted the case for a number of reasons. The case is hugely impactful. But also, if the Supreme Court didn’t intervene, lower court rulings would go into effect. At this point, mifepristone will remain available and approved; it’s a matter of how many hoops people will have to jump through to get it, and if the Supreme Court will interject itself into the FDA’s regulatory process.
The case began in an Amarillo, Texas district court in April 2023, when Judge Matthew J. Kacsmaryk, who was appointed by Donald Trump, ruled in favor of AHM and the physician plaintiffs. Under this ruling, mifepristone’s more than 20-year approval was upended.
“If this case hadn’t been filed in front of an activist, anti-abortion judge in Texas, then it would have been laughed out of court,” Donley said. “There’s no precedent for a court removing the approval of an FDA-approved drug on the basis of safety and efficacy against the FDA’s recommendations.”
But abortion is often treated as an exception to normal legal proceedings by some judges, she said.
Next, the case moved to the Fifth Circuit, an appellate court that oversees district courts in several states, including Texas. Donley noted that the Fifth Circuit is “one of the most conservative appellate courts in the country.”
In August 2023, that court ruled that the statute of limitations on challenging mifepristone’s FDA approval had passed. However, mifepristone was ruled back to pre-2016 restrictions.
Kirsten Moore, director of the Expanding Medication Abortion Access (EMAA) Project, said mifepristone prescribing underwent major changes in 2016, when the FDA dropped the requirements that a patient take the pill in the clinic. Then in 2021, providers were allowed to prescribe it after telehealth visits rather than requiring in-person visits. The FDA cited decades of research indicating the safety of these changes.
Now, the Supreme Court has only accepted the Fifth Circuit’s ruling, which means they won’t be considering the Texas district court’s ruling at all. Donley explained that next year, the Supreme Court could go back to pre-2016 or pre-pandemic changes, or dismiss the lawsuit entirely.
“The question … has to do with whether or not the Supreme Court that overturned Roe v. Wade is going to be willing to kind of engage in the gymnastics of the Fifth Circuit and the district court to issue an anti-abortion decision, or whether they’re going to follow traditional legal rules and dismiss this lawsuit,” Donley said.
Throughout this process, established medical societies have remained steadfast. The American College of Obstetricians and Gynecologists (ACOG) released a statement earlier this month urging the Supreme Court to protect mifepristone access and “return medical decisions to where they belong: to patients and their doctors.” ACOG, alongside the American Medical Association, the Society for Maternal-Fetal Medicine, and other medical and public health societies, also filed an amicus brief in October.
“This Court should not allow the speculative fears of a handful of doctors to deprive patients throughout the country of an essential medication that is proven safe for use in early pregnancy,” they wrote.
Donley sees wider-reaching ramifications if the court rules against the FDA. She said it could “potentially open up the floodgates for similar lawsuits to be filed.” Those lawsuits might challenge other evidence-based but politically polarizing medical care, such as contraception, gender-affirming care, [sexually-transmitted infection] treatments, vaccines, or COVID-related care.
“I think all physicians should be concerned about the Supreme Court kind of intervening in the practice of medicine in this way when, of course, the Supreme Court is not full of doctors, it’s full of lawyers,” Donley said.