WASHINGTON (OSV News) — A national pro-life organization and two Republican senators said Oct. 29 that they would push the Trump administration for more information regarding the Food and Drug Administration’s recent approval of a new generic form of mifepristone — a pill commonly, but not exclusively, used for early abortion.
In September, the FDA notified Evita Solutions that its generic version of mifepristone was approved, despite previous suggestions from FDA and Department of Health and Human Services officials that mifepristone would undergo a review. The approval of the drug sparked outcry from pro-life advocates, including Sens. Josh Hawley, R-Mo., and Bill Cassidy, R-La.
On a press call with those senators on Oct. 29, Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, which works to elect pro-life candidates to public office, said, “How did this administration, how did the FDA act when it was encountering a request for a generic new drug?”
“What they did was they approved a new generic abortion drug, then that abortion drug now makes the (abortion) pill far more available, far more accessible and far cheaper,” she said. “This is something that we should be outraged at, and we are.”
Dannenfelser argued any action that further expands the use of the drugs commonly used for abortion is “irresponsible.”
“I think the lack of response from the FDA, I can say this, from the FDA and from the HHS secretary, is just disrespectful to the American people, and to the women of America, and certainly disregards the lives of unborn children whom this administration purports to advance their cause,” she said.
Hawley and Cassidy both expressed concern about the FDA’s approval of the drug and said they had not yet received confirmation of a review of mifepristone pledged by Secretary of Health and Human Services Robert F. Kennedy Jr. and FDA Commissioner Dr. Martin Makary was underway — or would even take place at all, despite official inquiries.
“Both the secretary and the FDA commissioner pledged to me during their confirmation hearings — and have subsequently reiterated to others — that they will perform such a study,” Hawley said on the call. “Secretary Kennedy said as recently as this past month that the study was underway. I do not have an update, however, as I’ve not received one, of where the study is.”
“And what concerns me is that in the midst of this supposed study being performed, the FDA went and approved a new generic of the very drug that’s supposed to be being studied,” Hawley continued. “So this is, I think, deeply, deeply concerning.”
In comments posted on X earlier this month amid criticism from pro-life advocates over the drug’s approval, Kennedy said he and Makary in September sent a letter 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.”
Kennedy claimed 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.”
The Drug Price Competition and Patent Term Restoration Act of 1984, sometimes called the Hatch-Waxman Act, streamlined the approval process for generic drugs but still requires them to undergo a review to ensure they are “bioequivalent” to their name-brand counterparts and meet the FDA’s safety standards.
Cassidy, however, took aim at that argument on the press call, detailing the objections he made to the FDA about it.
“I was upset, I called them up,” he said. “‘Why are you doing this?’ ‘Well, we’re required to by law.’ ‘Hang on, like the Biden administration didn’t do it and you did?'”
Cassidy acknowledged that the ongoing government shutdown may delay a response from health officials, but said he planned to further question FDA officials about the approval.
“But (the) fact is, I thought it was unwarranted, and I let my displeasure be known,” he said. “That said, it’s going to be hard to reel back.”
On its website, Evita Solutions calls mifepristone “an effective, safe way to terminate early pregnancy.”
The Catholic Church teaches that all human life is sacred from conception to natural death, and as such, opposes direct abortion.
Approved by the FDA for early abortion in 2000, mifepristone — the first of two drugs used in a medication-based abortion — gained the moniker “the abortion pill.” However, the same drug combination has become used sometimes in recent years for miscarriage care, where an unborn child has already passed, a situation that Catholic teaching would hold as morally licit use.
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