The Food and Drug Administration has begun a new review of mifepristone safety, with officials expected to examine telehealth prescribing, mail-order distribution and Biden-era changes that expanded access to the abortion drug.
By yourNEWS Media Newsroom
The Food and Drug Administration has launched a new safety review of mifepristone, the abortion pill whose expanded use through telehealth and mail-order distribution has drawn growing scrutiny from pro-life advocates and Republican lawmakers.
Trump administration officials told The Wall Street Journal that the review could take about six months and is expected to focus on mifepristone’s safety as chemical abortion has become more common across the country.
The review marks a major step for pro-life organizations that have urged the administration to reexamine federal policies allowing abortion pills to be prescribed without an in-person medical visit. Those groups have argued that the Biden administration weakened safeguards and that complications from chemical abortions are underreported.
The FDA currently says mifepristone is safe when used as directed. Abortion opponents, however, have pressed the agency to revisit its monitoring system and reinstate earlier restrictions, including in-person supervision requirements.
Sen. Bill Cassidy, R-La., chairman of the Senate Health Committee, said the administration should act quickly.
“We already know chemical abortions kill babies and endanger women,” Cassidy told the Journal. “The Trump administration needs to stop dragging their feet and immediately reinstate the in-person requirement.”
Many pro-life advocates are not focused primarily on removing mifepristone from the market, but on restoring safety rules that were relaxed in recent years. Their concerns have centered on telehealth prescribing, mail delivery and the ability of women to receive abortion drugs without an in-person examination.
Use of abortion pills increased after the Supreme Court overturned Roe v. Wade in 2022. Telehealth access also grew, allowing providers in states where abortion remains legal to prescribe and mail the drugs to women in states with tighter abortion limits.
Administration officials said the FDA had been collecting information and preparing the review for months. The process reportedly accelerated after discussions with pro-life organizations and an October deadline set by a Louisiana court overseeing litigation involving mifepristone.
Officials said preliminary findings could come as early as July, with the full review expected by the end of the year.
The review comes as some pro-life leaders have grown frustrated with the pace of federal action on abortion-pill regulation. Trump has generally said abortion policy should be handled by the states, but pro-life groups argue the federal government still has authority over abortion drugs through FDA regulation.
White House officials recently met with representatives from Susan B. Anthony Pro-Life America, one of the groups pushing for stronger federal review 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 abortion-pill regulations.
Acting FDA Commissioner Kyle Diamantas has reportedly told pro-life leaders that the agency remains committed to reviewing the issue. Public records also show that he met with Cassidy in May about the study.
Abortion-rights advocates criticized the new review and said existing research supports mifepristone’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.
The review could determine whether the Trump administration moves to restore in-person requirements or impose other limits on how mifepristone is prescribed and distributed. For now, the FDA’s study places the abortion pill back at the center of the national fight over federal abortion policy, state restrictions and the scope of agency authority over medication abortion.
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