Senators, pro-life group seek answers on FDA approval of abortion pill

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(The Center Square) – Two Republican U.S. senators and a national pro-life organization say they want the Trump administration to explain why the U.S. Food and Drug Administration approved a new generic version of the abortion pill mifepristone.

In September, the FDA notified Evita Solutions that its generic version of the drug was approved. The decision came despite earlier statements from the FDA and Department of Health and Human Services that the drug would be reviewed before any new approval.

The approval drew backlash from pro-life advocates, including U.S. Sens. Josh Hawley, R-Missouri, and Bill Cassidy, R-Louisiana, and Susan B. Anthony Pro-Life America President Marjorie Dannenfelser.

“How did this administration, how did the FDA act when it was encountering a request for a generic new drug?” Dannenfelser said during a media call Wednesday. “What they did was they approved a new generic abortion drug, then that abortion drug now makes the pill far more available, far more accessible, and far cheaper. This is something that we should be outraged at, and we are.”

Dannenfelser said the decision “disregards the lives of unborn children” and called it “disrespectful to the American people, and to the women of America.”

Hawley said he has not received any confirmation that the review of mifepristone promised by Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Martin Makary is underway.

“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. “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.

“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,” he added. “So this is, I think, deeply, deeply concerning.”

Kennedy said earlier this month that he and Makary had sent a letter to state attorneys general “pledging to review all the evidence – including real-world outcomes – on the safety of this drug.” 

Additionally, Kennedy said 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.”

Cassidy disputed that explanation.

“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 said he plans to question FDA officials further about the decision. 

“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.”

Mifepristone was first approved in 2000 for use in early abortions. Evita Solutions describes the pill on its website as “an effective, safe way to terminate early pregnancy.”