While some Republicans have criticized the U.S. Food and Drug Administration’s recent move to approve an application for generic mifepristone tablets used to terminate early pregnancies, White House Press Secretary defended it Friday.
“It’s not an endorsement of this drug by any means, they are just simply following the law,” she said of the Health and Human Services Department, which oversees the FDA, and HHS Secretary Robert F. Kennedy Jr.
According to documents provided by the FDA, Evita Solutions, LLC submitted a risk evaluation and mitigation strategy in April. It’s abbreviated new drug application (ANDA) was approved Monday.
“We have completed the review of this ANDA and have concluded that adequate information has been presented to demonstrate that the drug meets the requirements for approval under the FD&C Act,” said the FDA. “Accordingly the ANDA is approved, effective on the date of this letter.”
Evita Solutions’ medication comes in the form of 200 mg mifepristone tablets and is equivalent to the Danco Laboratories reference drug, per the FDA. Evita’s website said the tablets were approved for use up to 70 days from the first day of the last menstrual period of the people who take them.
“Mifepristone blocks the hormone needed for pregnancy to continue, and misoprostol causes contractions to expel the pregnancy from the body,” Evita explained.
After news of the FDA’s decision this week came out, at least two Republicans criticized the move.
“I fully support President Trump’s Pro-Life, Pro-Family agenda, but the FDA approving one more tool to kill babies is a betrayal,” said U.S. Sen. Bill Cassidy (R-La.), a doctor who has also criticized Kennedy’s vaccine comments, in a Thursday X post. “This is not what Commissioner [Marty] Makary and Secretary Kennedy indicated they would do in their confirmation hearings.”
“FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution. I have lost confidence in the leadership at FDA,” said U.S. Sen. Josh Hawley (R-Mo.), also in an X post.
Previously, the conservative-leaning U.S Supreme Court (including three justices appointed by President Donald Trump) overturned longstanding abortion protections established by Roe v. Wade. Last March, Audacy reported that provisions for medications used for self-managed abortion increased after that ruling.
Though Trump has claimed the Supreme Court’s overturning of Roe v. Wade as a personal success, he also has said he believes some conservative pro-life stances go to far. For example, he said he thought Project 2025’s abortion policy – which called on the FDA to revoke approval of the abortion pill mifepristone that was granted in 2000 – was too extreme. First Lady Melania Trump has also defended women’s right to choose.