The Supreme Court on Thursday morning unanimously dismissed a challenge brought by a doctors’ group against the FDA’s loosening of regulations on the abortion pill mifepristone, giving a victory to the agency.
The court held that those challenging the status of the pill lacked legal standing to do so.
The ruling was made two years after the Supreme Court’s pivotal 2022 decision in Dobbs v. Jackson Women’s Health Organization, which reversed Roe v. Wade and shifted the authority over abortion regulations back to individual 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 typically uses mifepristone, which blocks the hormone progesterone, and misoprostol, which causes contractions.
Misoprostol, widely used in medicine for various purposes, is not contested in the ongoing legal case. Mifepristone, also known as mifeprex or RU-486, is manufactured 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 followed a ruling by Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas, appointed by President Donald Trump, who in April 2023 declared that the FDA erred in approving mifepristone for public use in 2000. He alleged the FDA rushed the pill to market due to political pressures and intentionally delayed judicial scrutiny of the drug for many years thereafter.
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 revised the official label of the drug, extending the allowable period for its use from 49 days to 70 days of gestation.
Concurrently, the agency permitted the drug to be prescribed after just one in-person visit and discontinued the mandate for prescribers to 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 5th Circuit Court of Appeals declined to halt most of Judge Kacsmaryk’s decision, suggesting that the FDA’s actions in 2016 and 2021 might have been illegal.
The Supreme Court intervened to lift the injunction against the initial approval of the drug, permitting mifepristone to stay available, but notably declined to commit to reviewing the legality of its original approval in 2000.
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.
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