The Food and Drug Administration has launched a new safety review of the abortion pill mifepristone, a move welcomed by pro-life advocates who have been urging the Trump administration to take a closer look at the drug and the Biden-era policies that expanded access to it.
Administration officials told The Wall Street Journal the study could take about six months to complete and is expected to focus on the safety of mifepristone, particularly as its use has increased through telehealth appointments and mail-order distribution.
The review marks a significant development for pro-life groups and congressional Republicans who have argued that federal regulators should reexamine policies that allow women to obtain abortion pills without an in-person doctor's visit.
"We already know chemical abortions kill babies and endanger women," Sen. Bill Cassidy, R-La., chairman of the Senate Health Committee, told the Journal. "The Trump administration needs to stop dragging their feet and immediately reinstate the in-person requirement."
The FDA currently states that mifepristone is safe when used as directed. Pro-life advocates, however, have long argued that the agency's safety monitoring is inadequate and that complications associated with chemical abortions are underreported.
Rather than seeking to remove the drug from the market entirely, many abortion opponents are focused on restoring safeguards that were relaxed in recent years, including requirements for in-person medical supervision.
Use of abortion pills increased sharply after the Supreme Court overturned Roe v. Wade in 2022. Telehealth prescribing also expanded, allowing providers in abortion-friendly states to prescribe and mail the drugs to women living in states with tighter abortion restrictions.
Administration officials said the FDA had been gathering data and preparing for the study for months. The effort reportedly accelerated following discussions with pro-life organizations and an October deadline imposed by a Louisiana court overseeing litigation involving mifepristone.
Officials said they expect preliminary findings as early as July and expect to complete the review by the end of the year.
The review comes amid growing frustration among some pro-life leaders, who have pressed the Trump administration to take stronger action on abortion-pill regulation. While President Donald Trump has generally supported allowing states to set abortion policy, many pro-life groups have argued that the federal government still has authority to regulate abortion drugs nationwide.
White House officials recently met with representatives of Susan B. Anthony Pro-Life America, one of the organizations urging greater federal scrutiny of mifepristone.
Earlier this year, the Supreme Court left broad access to mifepristone in place while legal challenges continue. A Louisiana judge also ordered the FDA to provide an update by October on its review of the agency's abortion-pill regulations.
Acting FDA Commissioner Kyle Diamantas has reportedly reassured pro-life leaders that the agency remains committed to reviewing the matter. Public records show he also met with Cassidy in May regarding the study.
Abortion-rights groups criticized the review and maintained that existing research supports the drug's safety.
"Hopefully they will adhere to FDA's gold standard for science, and we will learn once again that mifepristone is a safe and effective medicine, and the telehealth model of care is also safe and effective," Kirsten Moore, director of the Expanding Medication Abortion Access Project, told the Journal.
Nicole Weatherholtz ✉
Nicole Weatherholtz, a Newsmax general assignment reporter covers news, politics, and culture. She is a National Newspaper Association award-winning journalist.
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