(Oregon Right to Life) — The U.S. Food and Drug Administration last week confirmed it is moving forward with its safety review of the abortion drug mifepristone. The update reportedly marks the next phase of the review, which the FDA announced last year.
The Wall Street Journal was the first outlet to report on the development on June 4, framing it as the launch of the mifepristone review and “a step that could pave the way for the Trump administration to restrict how it is distributed and used.”
In comments to CBS News, a senior FDA official confirmed that the agency was moving forward with the study – though the outlet noted that “[a]dministration officials dispute the study is just starting.” Spokespeople for both the White House and the FDA stated that the review has been in progress for months, with the FDA spokesperson asserting that “[a]ny 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.”
A spokesperson for the White House told CBS that the review is now entering into a new phase with a focus on data analysis.
In response to the reporting, National Right to Life issued a press release commending the FDA for pursuing the research.
“For years, pro-life advocates, medical professionals, and members of Congress have raised serious concerns about the weakening of safety protections surrounding chemical abortion. We welcome a thorough and transparent review of the evidence,” said Carol Tobias, president of National Right to Life. “The abortion industry has repeatedly insisted that the safety issues surrounding chemical abortion are settled science. Yet the FDA itself has determined that additional review is appropriate.”
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“Each abortion takes the life of a preborn child and places her mother at risk. Women aborting at home are also more likely to be traumatized when they realize that they aborted a living child and not just ‘tissue’ or ‘products of conception’ as the abortion industry claims,” she said. “When the health and safety of women are involved, no legitimate scientific question should be off limits.”
“Every woman deserves the highest standard of medical care,” Tobias concluded. “The FDA has both the authority and the responsibility to act. We encourage the agency to conduct this review with transparency, scientific integrity, and an unwavering commitment to protecting women.”
The first drug in the abortion pill regimen, mifepristone blocks the action of the growth hormone progesterone, causing the growing human fetus or embryo to die of starvation. A second drug, misoprostol, is taken to expel the unborn baby’s body. Chemical abortion now accounts for well over half of all U.S. abortions amid the rollback of federal regulations over the past decade, especially the Biden-era elimination of rules prohibiting the online prescription of mifepristone and its distribution through the mail.
Pro-life advocates have long raised the alarm that – in addition to their intended lethality for the unborn – the ready availability of abortion drugs poses serious risks of adverse events, puts women at increased risk of coercion and forced abortion, and undercuts state laws protecting unborn lives.
RELATED: U.S. Senate Committee Launches Investigation into Sales of Dangerous Chemical Abortion Drugs
Last year, the Ethics and Public Policy Center (EPPC) released a bombshell study calculating the severe complication rate associated with the drug to be twenty-two times the one currently listed on its official FDA label, raising serious concerns for the safety of women who consume the drugs and renewing calls for a restoration of regulations.
The FDA’s announcement that it would conduct its safety review of the drug came in the wake of the EPPC report.
Since the FDA announcement, however, pro-life advocates have expressed frustration with the agency for approving a generic version of the abortion pill and for failing to quickly produce a report. A December Bloomberg report sparked additional controversy for reporting – citing individuals familiar with the matter – that then-FDA Commissioner Marty Makary had told officials to slow-walk the review until after the 2026 midterm elections.
Dr. Makary denied the allegations in comments to The Daily Signal at the time.
READ: Pro-Life Advocates Increase Pressure on FDA to Conduct Abortion Pill Review: FDA Head Responds
Meanwhile, the most recent statements from the FDA concerning mifepristone come after a federal appellate court in late April issued a decision that would have effectively reinstated the in-person dispensing requirement for the abortion drug. The U.S. Supreme Court quickly issued a stay against the decision, later issuing an order permitting the distribution of dangerous abortion pills through the mail pending the resolution of the original suit.
In its June 5 report, CBS said the FDA’s interim study results could be released as early as next month.
