The Trump administration is under fire from pro-life advocates after the U.S. Food and Drug Administration (FDA) quietly approved a new generic version of the abortion drug mifepristone on Tuesday, Sept. 30.
The drug is manufactured by Evita Solutions LLC, a company that openly declares its mission is to “normalize abortion” and make it “accessible to all.”
Health Secretary Robert F. Kennedy, Jr. indicated in a statement on the evening of Oct. 2 that he stands by his past criticism of the Biden administration for nixing mifepristone’s “in-person dispensing rule without studying the safety risks.”
“We are filling that gap,” Kennedy wrote. “Last month, I joined [FDA Commissioner Dr. Marty Makary] in writing to state attorneys general, pledging to review all the evidence — including real-world outcomes — on the safety of this drug. Recent studies already point to serious risks when mifepristone is used without proper medical oversight.”
The FDA “only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug,” Kennedy wrote.
The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap. Last month, I joined @DrMakaryFDA in writing to state attorneys general, pledging to review all the evidence — including real-world outcomes — on… pic.twitter.com/G0eE4H4y42
— Secretary Kennedy (@SecKennedy) October 2, 2025
Kennedy’s explanation will likely do little to quell pro-life leaders’ concerns.
Earlier in the day, Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, blasted the FDA’s move as “unconscionable,” warning it will expand the reach of abortion pills that already account for nearly two-thirds of all abortions nationwide.
“These dangerous drugs take the lives of unborn children, place women and underage girls at serious risk, empower abusers, and trample the pro-life laws enacted by states across the nation,” Dannenfelser said in a statement.
She pointed to September testimony from Kennedy and Makary, who acknowledged evidence of “safety signals” tied to the drugs and promised a deeper review. “The prompt completion of the review is made more urgent given this approval to flood the market with a cheap abortion drug,” Dannenfelser added.
The pro-life leader demanded the reinstatement of safeguards in place during the first Trump administration, including a return to in-person medical oversight.
“Women are endangered by taking the drugs without a sonogram to check for ectopic pregnancy and confirm the gestational age of the child,” she said. “President Trump believes states have the right to pass and enforce pro-life protections. Yet every day this right is being trampled upon by the abortion industry.”
Data cited by the Foundation for the Restoration of America and the Ethics & Public Policy Center indicate that 11% of women who undergo chemical abortions experience severe adverse events such as hemorrhage, sepsis, and infection.
Last month, the Department of Health and Human Services announced it would open a study into the real-world harms of abortion drugs, following pressure from Republican attorneys general after the Biden administration dismantled safety rules.
Pro-life advocates warn the mail-order distribution of abortion pills has turned them into tools of coercion. Abusive partners have slipped the drugs to women without their knowledge, while other women have been pressured into taking the drugs discreetly by boyfriends or family members.
The reality, Dannenfelser said, is grim: “With abortion drugs now accounting for 63% of all abortions, these pills are responsible for the deaths of millions of Americans.”
News of the FDA’s decision sparked many other strong reactions across social media, with pro-life leaders and concerned citizens voicing outrage.
In a press release sent to CatholicVote via email, John Mize, the CEO of Americans United for Life (AUL), commented on the FDA’s announcement: “Americans United for Life is deeply disappointed and concerned at the decision by the FDA, especially considering data highlighting the increased complication rate for women ingesting the medication without physician oversight or even the original REMS required for medications that provide potential risks.”
Republican Sen. Josh Hawley of Missouri posted on X: “This is shocking. FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother. And of course 100% lethal to the child.”
“FDA had promised to do a top-to-bottom safety review of the chemical abortion drug,” Hawley added, “but instead they’ve just greenlighted new versions of it for distribution. I have lost confidence in the leadership at FDA.”
Students for Life President Kristan Hawkins denounced the fact that “the FDA just gave the abortion industry exactly what it wanted: more pills, less oversight, more dead children. This isn’t healthcare—it’s abandonment of women.”
On her X account, Lila Rose of LiveAction called the move “UNACCEPTABLE,” adding: “This drug starves babies and harms mothers! The FDA just said it would do a new serious safety study—so why approve another generic now? @RobertKennedyJr must reverse this decision!”