How the Supreme Court Could Rule in the Abortion Pill Case
The Supreme Court is taking up the abortion pill. The high court announced Wednesday that it would hear a pair of lawsuits brought by doctors and medical groups opposed to abortion, whose challenge to the abortion drug, known as mifepristone, resulted in a court order invalidating the Food and Drug Administration’s approval of the drug — one that was eventually partially struck down on appeal. This case would mark the first major abortion decision since the high court overturned Roe v. Wade last year.
Understanding Mifepristone and its Medical Use
Mifepristone, also known as RU-486, is a medication typically used in combination with misoprostol to bring about a medical abortion during pregnancy and manage early miscarriage. The reality is that mifepristone was approved after a politically fraught journey given intense opposition from anti-abortion groups. It took 4 years of FDA deliberations from submission to approval, despite a plethora of completed clinical studies, strong support from medical organizations, and over 10 years of safe use in Europe. Abortion medication is now used in over half of all pregnancy terminations.
The two-pill regimen (mifepristone and misoprostol) is highly safe and effective. Compared with surgical abortion, abortion medications promote privacy, dignity, and convenience. As highlighted in the clinical data:
| Metric | Rate of Occurrence |
|---|---|
| Serious complications requiring hospitalization | 0.3% |
| Ongoing pregnancy | 1.1% |
Notably, serious complications occur in fewer than Tylenol or Viagra cases. If FDA's approval of mifepristone is overturned, the drug would be unmarketable in all 50 states, and 65 million women of reproductive age would lose access to the most effective form of existing medication abortion care.
The Legal Challenge and FDA Authority
The hyper-conservative anti-abortion group Alliance Defending Freedom (ADF) is seeking to overturn the FDA's approval of mifepristone (Mifeprex), a medication in a two-pill regimen used to terminate pregnancies through the first 10 weeks gestation. ADF claims FDA exceeded its authority in approving mifepristone in 2000. FDA acted under a federal law authorizing the agency to grant "accelerated approval" to drugs "studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments."
A United States appeals court has already ruled to restrict access to the abortion pill mifepristone, ordering a ban on telemedicine prescriptions and shipments of the drug by mail. It also limited its use to up to seven weeks of pregnancy, rather than 10. “At this point, it’s really up in the air,” says Daniel Urman, director of hybrid and online programs in the School of Law.
Potential Rulings and Judicial Perspectives
While the court has yet to hear oral arguments, Dan Urman says he sees the justices siding with the Biden administration and the drug companies, which asked the Supreme Court to intervene to preserve access until the dispute is resolved. He suggests that “the court will likely rule for the FDA and the drug companies because upholding such a severe limitation on the FDA’s approval process would throw so much of the FDA’s work into question — including all sorts of life-saving drugs.”
Urman says that indicates that the justices may be concerned with issues of standing, or who can bring the lawsuit, not the merits. They might find a way to limit standing of doctors to sue. If they grant doctors standing, this means non-prescribing doctors could always try to invalidate the approval of drugs, which is unlikely to be something the justices want to do.
Wendy Parmet, a professor at Northeastern University School of Law, notes that the high court’s initial pause on the lower court’s changes, coupled with its decision not to grant the plaintiffs’ petition, suggests a reluctance to completely eliminate the drug from the market. However, because the Supreme Court took a narrower approach in reviewing the issue, it may signal that a Texas lawsuit could still be disastrous for effective abortion access and FDA's authority.