(Fixes typo in paragraph 6)
June 5 (Reuters) – The FDA has launched a safety study of the abortion pill, also called mifepristone, a step that could pave the way for the Trump administration to restrict how it is distributed and used, the Wall Street Journal reported on Thursday.
The FDA has said mifepristone continues to be safe and effective for its intended purpose when used as directed.
A spokesperson for the U.S. Department of Health and Human Services, which oversees the FDA, refuted reporting that a study was just being started, saying that the agency “has been actively working on a science-based safety review of the mifepristone REMS for months”.
The study, which has the White House’s backing, would use existing drug-safety systems, is expected to take six months and is intended to withstand legal criticism, the report said.
The FDA is also considering hiring a contractor to acquire and analyze data on mifepristone use, the report added, citing administration officials.
On Friday, Alexis McGill Johnson, president and CEO of Planned Parenthood Action Fund, said the review was a “politically motivated farce” and that “mifepristone is safe and effective.”
“The Trump administration is bulldozing the overwhelming body of medical research and evidence to try to make it harder for everyone, everywhere to get an abortion,” Johnson said in a press release.
In May, the U.S. Supreme Court ensured the abortion pill could continue to be prescribed through telemedicine and dispensed by mail when it restored a 2023 federal rule that had made access to the medication easier while a challenge brought by Republican-governed Louisiana made its way through the courts.
The Journal said some officials expected preliminary, internal results to be available in July. The full results are unlikely to be completed before November’s midterm elections, the report added.
Medical abortion, typically a two-drug regimen consisting of mifepristone followed by misoprostol, accounts for about two-thirds of U.S. abortions and is used to terminate a pregnancy within the first 10 weeks.
Abortion rights advocates have called the legal challenges to mifepristone the biggest threat to abortion access in the U.S.
The battles over abortion rights follow a 2022 Supreme Court ruling that overturned Roe v. Wade – a precedent that had recognized a woman’s constitutional right to terminate her pregnancy and legalized abortion in the United States.
(Reporting by Mrinmay Dey in Mexico City; Editing by Himani Sarkar, Kate Mayberry and Aurora Ellis)
