The Supreme Court unanimously rejected a challenge Thursday morning brought by a doctors’ group against the Food and Drug Administration’s (FDA) loosening of regulations of the abortion pill mifepristone, handing a win to the agency.
The court held that those challenging the status of the pill lacked legal standing to do so.
The decision came two years after the court’s landmark 2022 ruling in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and returned the regulation of abortion to the states.
The 9–0 opinion was written by Justice Brett Kavanaugh. Justice Clarence Thomas filed a concurring opinion.
Medication abortions are reportedly lawful in 36 states and the District of Columbia.
A medication abortion generally involves the use of mifepristone, which blocks progesterone, a hormone, and misoprostol, which induces contractions. Misoprostol, which is widely available because it has many medical uses, isn’t an issue in the current litigation. Also known as mifeprex and RU-486, mifepristone is made by Danco Laboratories.
Advocates for mifepristone said the current system by which the drug is provided is safe, while opponents said it puts women at risk by ignoring safety measures that used to be in place.
The Biden administration and pro-abortion groups warned that the Supreme Court’s eventual decision in the case could affect the drug’s availability.
The case is actually two appeals that the court consolidated - Food and Drug Administration (FDA) v. Alliance for Hippocratic Medicine (AHM) and Danco Laboratories LLC v. AHM.
The Supreme Court case came after Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas, an appointee of President Donald Trump, held in April 2023 that the FDA was wrong to approve mifepristone for public use in 2000. He said the FDA was under political pressure to get the pill on the market and then, after that, had deliberately dragged out judicial review of the drug for years.
Judge Kacsmaryk found the FDA had improperly lifted restrictions related to accessing the drug and issued a preliminary nationwide injunction retroactively staying the FDA’s approval.
In 2016, the FDA changed the drug’s official label, extending the cutoff for use from 49 days of gestation to 70 days. At the same time, the agency allowed the drug to be prescribed with only one in-person visit and halted the requirement that prescribers report nonfatal adverse events.
In 2021, the agency allowed patients to receive the drug by mail instead of having to pick it up in person from a specially certified health care provider.
The U.S. Court of Appeals for the 5th Circuit refused to block most of Judge Kacsmaryk’s ruling, holding that the FDA’s actions in 2016 and 2021 were probably unlawful. The Supreme Court blocked the injunction over the original approval of the drug, allowing mifepristone to remain on the market, but pointedly refused to agree to commit to examining whether the original approval of the drug in 2000 was lawful.
During oral arguments at the Supreme Court on March 26, much of the discussion focused on legal standing, that is, the connection a litigant has to a controversy before the court.
This is a developing story...
