June 4 (Reuters) – The FDA has initiated a safety assessment of the abortion pill, known as mifepristone, which could lead to the Trump administration imposing restrictions on its distribution and use, according to a report by the Wall Street Journal on Thursday.
The FDA maintains that mifepristone remains safe and effective for its prescribed use when guidelines are followed.
Reuters has not yet confirmed the report. The FDA did not immediately respond to Reuters’ request for comment outside of regular business hours. In May, the U.S. Supreme Court allowed the continued prescription of the abortion pill via telemedicine and delivery by mail, following the reinstatement of a 2023 federal regulation that facilitated access to the drug while a legal challenge from Republican-led Louisiana proceeded through the courts.
Supported by the White House, the study aims to use existing drug-safety monitoring systems, is projected to last six months, and seeks to withstand any legal scrutiny, according to the report.
The FDA is also contemplating the engagement of a contractor to gather and evaluate data on the use of mifepristone, as cited by administration officials in the report.
The Journal mentioned that some officials expect initial internal findings to be ready by July, while complete results are not anticipated before Novemberâs midterm elections, the report noted.
Medical abortions, typically involving a two-drug combination of mifepristone followed by misoprostol, comprise approximately two-thirds of abortions in the U.S. and are used within the first 10 weeks of pregnancy.
Advocates for abortion rights have described the legal challenges to mifepristone as the most significant threat to abortion access in the U.S.
The ongoing debates over abortion rights follow a 2022 Supreme Court decision that overturned Roe v. Wade, a precedent that had affirmed a womanâs constitutional right to an abortion in the United States.
(Reporting by Mrinmay Dey in Mexico City; Editing by Himani Sarkar and Kate Mayberry)
