FDA studying safety of abortion pill — report

The U.S. Food and Drug Administration (FDA) has launched a safety study of the abortion pill, also known as mifepristone, a move that could allow the Trump administration to impose new restrictions on its distribution and use, according to the Wall Street Journal on Thursday.

The FDA has maintained that mifepristone remains safe and effective when used as directed. Reuters could not immediately verify the report, and the FDA did not respond to a request for comment outside regular office hours.

In May, the U.S. Supreme Court restored a 2023 federal rule allowing the abortion pill to be prescribed through telemedicine and dispensed by mail. This decision ensures continued access to the medication while a legal challenge brought by Republican-led Louisiana works its way through the courts.

The study, which has the backing of the White House, will rely on existing drug-safety systems. It is expected to take six months and is designed to withstand legal scrutiny, the Journal reported. Officials also indicated that the FDA is considering hiring a contractor to gather and analyze data on mifepristone use.

Preliminary internal results are expected as early as July, but the full findings are unlikely to be released before the midterm elections in November, the report added.

Medical abortion, which typically involves a two-drug regimen of mifepristone followed by misoprostol, accounts for roughly two-thirds of U.S. abortions and is used to terminate pregnancies within the first 10 weeks.

Abortion rights advocates have described the legal challenges to mifepristone as the most significant threat to abortion access in the country. These battles follow the 2022 Supreme Court ruling that overturned Roe v. Wade, the precedent that had recognized a woman’s constitutional right to terminate her pregnancy.

-Reporting by Mrinmay Dey in Mexico City; Editing by Himani Sarkar and Kate Mayberry/Reuters