The Food and Drug Administration announced Friday that it is moving ahead with a safety review of the abortion pill mifepristone, responding to months of pressure from anti-abortion lawmakers and activists who have urged the federal government to take a closer look at the drug’s oversight and availability.
According to an administration official, the review is a retrospective analysis of existing data and is expected to take approximately six months to complete. However, preliminary findings could be released before the full review is finished.
The official also pushed back against criticism from anti-abortion lawmakers who have accused the administration of delaying the process. According to the administration, work on the review has already been underway for several months.
The announcement comes amid continued debate over abortion policy following major shifts in state laws across the country. While some states have moved to restrict or ban abortion access, medication abortion has remained widely available through alternative channels, creating ongoing legal and political battles over federal oversight and enforcement.
In a statement released Friday, the FDA emphasized that the review is being conducted according to established scientific standards and rejected suggestions that the agency had only recently begun the process.
“The FDA has been actively working on a science-based safety review of the mifepristone REMS for months, as the agency has stated publicly and in court filings,” the agency said.
The agency also criticized reports suggesting the review was only now getting underway.
“Any reporting suggesting otherwise, including that a study is just being started, is either false or based on a fundamental misunderstanding of how complex scientific safety studies work,” the statement added.
Pressure on the White House has intensified in recent months as anti-abortion lawmakers and advocacy groups have called for tighter restrictions on mifepristone. One of the primary concerns raised by critics is that the drug can be distributed through the mail, allowing access even in states where abortion is heavily restricted or prohibited altogether.
The review reportedly gained momentum following a leadership change at the FDA. Marty Makary was removed as commissioner last month and replaced by acting Commissioner Kyle Diamantis.
According to the administration official, the transition in leadership helped accelerate the review process. Diamantis has reportedly maintained regular communication with leaders in the anti-abortion movement during his tenure as acting commissioner.
His appointment was not without controversy. Some Republicans questioned the selection because Diamantis previously worked as a private attorney and had co-led legal representation for Florida’s Planned Parenthood chapter.
Trump allies quickly sought to reassure critics, arguing that Diamantis removed himself from that case because of his anti-abortion beliefs.
Mifepristone was first approved by the FDA in 2000 as a method for ending early pregnancies. The drug is commonly used in combination with a second medication, misoprostol.
Today, medication abortion represents the most common method of pregnancy termination in the United States. Access has expanded in part through mail-order pharmacies and through legal protections enacted in some states. So-called “shield laws” in certain states protect clinicians from prosecution, helping maintain access for women even as several conservative-led states have sharply restricted abortion clinics or banned abortion procedures altogether.
As the FDA continues its review, the findings are likely to be closely watched by lawmakers, activists, and healthcare providers on both sides of one of the nation’s most enduring political debates. The agency has indicated that its analysis will be guided by scientific data as it evaluates the existing safety framework surrounding mifepristone.
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