U.S. bishops: FDA approval of generic abortion drug is a ‘shocking inconsistency’

CNA Staff, Oct 8, 2025 / 09:00 am (CNA).

The U.S. Catholic bishops sharply criticized the Trump administration’s recent approval of the generic abortion drug mifepristone, saying that women and children deserve better care. 

The Food and Drug Administration (FDA) approved the drug even as the administration is currently investigating the abortion drug for safety concerns. 

U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. has previously acknowledged concerns over the safety of the drug and said in a hearing last month that the investigation is ongoing. Even so, the FDA’s approval of the generic version will make the drug even more accessible. 

“Mothers in need and their preborn children deserve better,” said Bishop Daniel Thomas, who heads the U.S. bishops’ pro-life committee, in response to the FDA’s decision. 

In a statement, Thomas called the decision “jarring” and “contradictory.”

“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,” Thomas said.

“The FDA took shortcuts in originally approving and loosening protocols for mifepristone, which enabled the killing of more children and placed the health of more women in danger,” he continued.

More than 1 in 10 women who take the abortion pill mifepristone to complete a chemical abortion will suffer a serious health complication within 45 days of taking the drug, a study by the Ethics and Public Policy Center found.

The study also found that the rate of serious adverse side effects occurs at 22 times the rate that the FDA-approved drug label currently indicates.

“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,” Thomas said. 

Dangers of drug 

Dr. Susan Bane, vice chair of the board of directors of American Association of Pro-life Obstetricians and Gynecologists, called the FDA’s decision “a serious misjudgment that will have deadly consequences.” 

Mifepristone poses a danger “not only to preborn babies but to unsuspecting pregnant women as well,” Bane, an OB-GYN with more than 25 years of experience in women’s health care, told CNA.

“When the side effects of this drug are already misreported and under-investigated, expanding access to it is the wrong course of action,” she said. 

Jennie Bradley Lichter, March for Life president, said she is “devastated” by the decision. 

“I’m devastated that this dangerous drug, which has serious adverse effects for 11% of women who take it, is getting a stronger and stronger foothold,” she said in a statement shared with CNA. 

Noting that the agency “has limited discretion under the law to decline approval for a generic that matches an approved name-brand drug,” Lichter expressed concerns for women and children.  

“Every day that mifepristone remains on the market, with very few safeguards in place around it, heaps danger upon danger for American women and results in more and more babies being killed,” Lichter said. 

Evita Solutions, LLC, the pro-abortion company producing the generic drug, has said it seeks to “normalize abortion.” 

But Thomas highlighted the importance of support and care for women and children.

Mothers and children “deserve the fullest, most authentic care that we can offer in all respects,” the bishop said.

Thomas looked ahead to the FDA investigation of the abortion drug mifepristone.

“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,” he said.

Source: https://www.catholicnewsagency.com/news/267025/us-bishops-fda-approval-of-generic-abortion-drug-is-a-shocking-inconsistency