“A few members of Congress” were reportedly told that the U.S. Food and Drug Administration (FDA) will finish its safety review of the abortion pill mifepristone by September.
A lawmaker who requested to remain anonymous told the Daily Signal of the development, as conservatives and pro-life advocates push the agency to undo a Biden-era regulation that allows abortion pills to be sent via mail without an in-person appointment.
The FDA first approved mifepristone in 2000 by classifying pregnancy as an “illness.” At the time, guardrails for the drugs — called Risk Evaluation and Mitigation Strategies (REMS) — required that only doctors could prescribe the drug, mandated three in-person visits before they could do so, and directed they report serious adverse events.
Since then, safety regulations have been slowly chipped away, including in 2016, when the agency said healthcare workers need to report only fatalities.
The pro-abortion Biden administration temporarily suspended the in-person requirement in 2021 and made the change permanent in 2023 as an act of defiance after the Supreme Court overturned Roe v. Wade. The FDA’s mail-order scheme has enabled abortionists in blue states to mail abortion drugs into states with pro-life laws, and blue states have passed “shield laws” protecting abortionists from adverse legal action in red states.
Many cases have also subsequently arisen of abusers obtaining abortion pills online and coercing or forcing women to take the drugs.
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According to the Signal report:
Pro-life members on the House Appropriations Committee earlier this month considered a provision in a bill funding the Agriculture Department and the FDA that would nullify a Biden-era rule allowing the abortion pill to be dispensed in the mail. However, they decided to instead wait for the FDA to release the safety review report.
“If the FDA finds that the abortion pill is unsafe, according to its review of data, it could then update its program for high-risk drugs, the Risk Evaluation and Mitigation Strategy, to restore the in-person dispensing requirement for mifepristone,” the report details.
Pro-life advocates and conservative Republicans pressed the FDA under President Trump to undertake a safety review of mifepristone after the release of a report last April suggesting that 11 percent of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a chemical abortion — which is significantly higher than the less than 0.5 percent in clinical trials reported on the FDA-approved drug label.
The State of Louisiana, along with Rosalie Markezich — a woman who alleges her boyfriend was able to order abortion drugs online from California and coerce her into taking the pills — are also suing the FDA over the mail-order regulation.
The Supreme Court in May allowed the mail-order abortion scheme to continue as litigation plays out in lower courts. Conservative-leaning Justices Samuel Alito and Clarence Thomas dissented, with Thomas writing that the two drug companies, Danco Laboratories and GenBioPro, are not entitled to the court’s action to prevent “lost profits from their criminal enterprise.”
The FDA under the Trump administration has not done much to confront the merits of the case but has instead asked the courts to allow the mail-order abortion scheme to continue while the agency conducts a safety review of mifepristone — a position that has drawn the ire of the pro-life community. Drug manufacturers Danco Laboratories and GenBioPro have intervened as defendants in the case and have argued that pausing mail-order abortions would cause them financial harm. The drug companies appealed to the Supreme Court after the Fifth Circuit paused the mail-order abortion rule.
The Department of Health and Human Services (HHS) did not respond to the Daily Signal’s request for comment. Breitbart News also reached out for comment and did not receive a response by time of publication.
White House spokeswoman Allison Schuster told the outlet that the Trump administration is “pursuing a rigorous review of mifepristone in response to widespread safety concerns, adhering to the highest scientific standards.”
“This Gold Standard Science-based safety review led by the FDA, which remains ongoing, is just one example of President Trump’s total commitment to thoroughly evaluating emerging drugs to ensure the health and safety of all Americans,” Schuster said.
In 2023, the Guttmacher Institute estimated that medication abortions accounted for 63 percent of all abortions within the formal U.S. healthcare system. That percentage was up from an estimated 53 percent in 2020 and 39 percent in 2017. The report did not account for abortion pills obtained through underground national and international networks, including those that send pills to women in states with abortion restrictions.
The pro-abortion organization estimated that 91,000 telehealth abortions were provided in 2025 under blue state shield laws to people in states with abortion restrictions.
In a medication abortion, mifepristone blocks the action of progesterone, which the mother’s body produces to nourish the pregnancy. When progesterone is blocked, the lining of the mother’s uterus deteriorates, and blood and nourishment are cut off to the developing baby, who then dies inside the mother’s womb. The drug misoprostol (also called Cytotec) then causes contractions and bleeding to expel the baby from the mother’s uterus.
Katherine Hamilton is a political reporter for Breitbart News. You can follow her on X @thekat_hamilton.
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