A top Catholic bishop decried the U.S. Food and Drug Administration’s approval of a new generic version of the abortion drug mifepristone as a “shocking inconsistency” that endangers women and facilitates the “killing of more children,” urging a swift reversal amid a pending federal safety review.
The FDA’s Octover 1 approval of the generic from Evita Solutions LLC — a company whose mission is to “normalize abortion” and make it “accessible to all” — comes as chemical abortions now account for 63% of all abortions in the United States, according to recent data, killing millions of babies
Pro-life advocates warn the move will flood the market with a cheaper, more readily available option for killing babies, potentially increasing the already staggering toll: over 1 million abortions annually nationwide, with mifepristone involved in more than half.
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“It is jarring and contradictory that, at the same time that the Food and Drug Administration is conducting a much-needed review of the supposed safety of the abortion pill for women, it is nonetheless approving a new generic for this deadly drug,” said Bishop Daniel E. Thomas of Toledo, Ohio, chairman of the U.S. Conference of Catholic Bishops’ Committee on Pro-Life Activities.
The USCCB, which has long championed the protection of unborn life as the foundational human right, highlighted the timing as particularly egregious.
Just last month, on September 19, the U.S. Department of Health and Human Services confirmed it would launch a study on the real-world harms of abortion drugs, responding to an inquiry from Republican attorneys general critical of the Biden administration’s rollbacks of safety protocols.
Bishop Thomas blasted the FDA’s original 2000 approval of mifepristone and subsequent loosening of restrictions under the Biden administration as shortcuts that “enabled the killing of more children and placed the health of more women in danger.”
“Even if it eventually had to be approved as a generic version of the same drug, to do so now and make it more available before a recently-announced safety study can be completed and potentially save lives, is a shocking inconsistency,” he said. “Mothers in need and their preborn children deserve better. They deserve the fullest, most authentic care that we can offer in all respects. I pray that the forthcoming review of mifepristone will undo many of these tragic developments and that we may, instead, meet women with hope and meaningful support.”
The approval arrives against a backdrop of mounting evidence on the drug’s risks.
Data cited by HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary indicate that 11% of women experience severe adverse events, including hemorrhaging, infection and sepsis — complications that pro-life groups say are exacerbated by the removal of in-person medical oversight, such as ultrasounds to detect ectopic pregnancies or confirm gestational age.
In September, Kennedy accused the prior administration of twisting data to “bury one of the safety signals,” assuring Congress that a thorough review was underway given “credible evidence of the harm inflicted by these drugs.” Makary echoed the call for urgency, especially now that the generic approval threatens to “flood the market with a cheap abortion drug.”
The USCCB’s pro-life arm had already sounded the alarm in July, joining a letter to the FDA commissioner with a Catholic Medical Association paper detailing mifepristone’s dangers to women. The bishops’ intervention underscored the church’s view that true compassion demands rejecting chemical abortions, which they describe as a violent assault on the most vulnerable.
As the safety study progresses, pro-life advocates are pressing for immediate action to restore Trump-era protections, including mandatory physician involvement and in-clinic dispensing. Both would protect women and likely save thousands of babies from abortions.
They frame the fight as essential to safeguarding both maternal health and the innocent lives of the unborn, estimated at over 63 million lost to abortion since Roe v. Wade was overturned in 2022.Bishop Thomas concluded with a call to hope: “I pray that the forthcoming review of mifepristone will undo many of these tragic developments.”
