The U.S. Food and Drug Administration has launched a safety study of the abortion pill mifepristone, a move that could pave the way for the Trump administration to impose new restrictions on its distribution and use, according to a report by the Wall Street Journal on Thursday.
The FDA has repeatedly stated that mifepristone is safe and effective when used as directed. Reuters could not independently verify the report, and the FDA did not immediately respond to a request for comment outside regular business hours.
Background and Legal Context
In May, the U.S. Supreme Court upheld a 2023 federal rule that expanded access to mifepristone, allowing it to be prescribed via telemedicine and dispensed by mail. This decision came amid ongoing legal challenges from Republican-led states, including Louisiana.
The new study, which has the backing of the White House, will leverage existing drug-safety monitoring systems. It is expected to take approximately six months and is designed to withstand potential legal scrutiny, the Journal reported.
Study Details and Timeline
The FDA is also considering hiring a contractor to collect and analyze data on mifepristone usage, according to administration officials cited by the Journal. Preliminary internal results could be available as early as July, but full findings are unlikely to be completed before the November midterm elections.
Medical abortion, which typically involves a two-drug regimen of mifepristone followed by misoprostol, accounts for roughly two-thirds of all abortions in the United States. It is used to terminate pregnancies within the first 10 weeks.
Implications for Abortion Access
Abortion rights advocates have described the legal challenges to mifepristone as the most significant threat to abortion access in the country. The ongoing battles over abortion rights follow the Supreme Court's 2022 decision to overturn Roe v. Wade, which had previously recognized a constitutional right to abortion and legalized the procedure nationwide.
The FDA's safety study could lead to regulatory changes that may restrict how mifepristone is prescribed and dispensed, potentially impacting millions of women who rely on medication abortion. Critics argue that the study is politically motivated and could undermine evidence-based medical practices.
