The Supreme Court is taking up the abortion pill: One way the justices could rule on access
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 Supreme Court has agreed to take up a case clarifying the availability of a widely used abortion pill after a series of rulings this year resulted in restricted access to the drug, though it remains on the market.
The Legal Challenge to FDA Approval
The high court announced that it would hear a pair of lawsuits brought by doctors and medical groups opposed to abortion, whose challenge to the abortion drug resulted in a court order invalidating the Food and Drug Administration’s approval of the drug. A United States appeals court has 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.
Following an appeal from the Justice Department, the Supreme Court temporarily halted any changes to the drug’s availability. Mifepristone’s availability remains unchanged for now, following an emergency order from the US Supreme Court in April preserving the status quo during the appeal. The case would mark the first major abortion decision since the high court overturned Roe v. Wade last year.
Potential Impact on the Pharmaceutical Industry
The Supreme Court on Tuesday will hear oral arguments in an abortion medication case that pharmaceutical companies warn could upend the industry and paralyze new drug development. Jeremy Levin, one of hundreds of pharmaceutical executives who have since signed onto amicus briefs and open letters, said: “This is a dagger at the heart of the entire industry.” He added, “I would venture to guess that if [the ruling stood], the industry will be thrown into complete disarray.”
Dan Urman, director of the law and public policy minor at Northeastern, says: “I think 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.”
History of Mifepristone Regulation
The following table outlines the regulatory timeline for mifepristone as managed by the Food and Drug Administration:
| Year | FDA Regulatory Action |
|---|---|
| 2000 | Approved for abortion up to seven weeks of pregnancy. |
| 2016 | Extended approval to 10 weeks of pregnancy. |
| 2021 | Removed the in-person dispensing requirement, citing years of data showing the drug’s relative safety. |
Questions of Standing and Future Access
Consolidating the two lawsuits, the court denied a third cross-petition from the Alliance for Hippocratic Medicine. Urman says that indicates that the justices may be concerned with issues of standing—or who can bring the lawsuit—not the merits of the FDA’s initial and subsequent approvals of mifepristone. He continues: “They might find a way to limit standing of doctors to sue — in this case, doctors who were not treating patients were given the right to challenge the FDA approval of mifepristone. If they grant doctors standing, this means non-prescribing doctors could always try to invalidate the approval of drugs. That’s unlikely to be something the justices want to do.”
Wendy Parmet, a professor at Northeastern University School of Law, says 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. At the same time, because the Supreme Court took a narrower approach in reviewing the issue, the final ruling could impact how the industry and federal agency operate moving forward.