The Food and Drug Administration has quietly approved a generic form of mifepristone, one of the two medications used in most abortions in the U.S., and pro-lifers are sounding an alarm about the dangers of the pill.
The FDA announced in a letter to drugmaker Evita Solutions LLC., that it signed off on a low-cost version of mifepristone.
That's the drug most commonly used in chemical abortions, and it is now reportedly being used in more than 6 in 10 abortions in the United States.
The drugmaker previously sent an abbreviated drug application (ANDA) for mifepristone to the FDA on October 1, 2021. In the letter, the FDA outlined that the company could begin manufacturing generic 200 mg mifepristone tablets as of September 30, 2025.
"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," states the letter. "Accordingly the ANDA is approved, effective on the date of this letter. We have determined your Mifepristone Tablets, 200 mg to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Mifeprex (mifepristone) tablets, 200 mg, of Danco Laboratories, LLC NDA - 020687."
This marks the second time the Trump administration has approved the generic abortion drug for the market. Pharmaceutical company GenBioPro brought the first one to market after it was approved in 2019.
The FDA's approval comes weeks after Health and Human Services Secretary Robert F. Kennedy Jr. announced that the FDA would review the safety of mifepristone.
"HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug [mifpristone]," FDA Commissioner Martin Makary wrote in an earlier letter.
As CBN News reported, a new analysis of data from more than 800,000 women who were prescribed mifepristone found that many of the participants had serious adverse side effects from the drug, including sepsis, infection, hemorrhaging, or other serious adverse events within 45 days of taking the drug.
The FDA's announcement has been met with swift condemnation from pro-life advocates and politicians.
Most notably, former Vice President Mike Pence called for RFK Jr.'s resignation because of the move:
"The Trump Administration's approval of a generic chemical abortion drug is a complete betrayal of the pro-life movement that elected President Trump.... President Trump must immediately reverse this decision. RFK must resign and give President Trump the opportunity to appoint a new Secretary of HHS who will protect the sanctity of life. The fight for life continues."
The Trump Administration’s approval of a generic chemical abortion drug is a complete betrayal of the pro-life movement that elected President Trump.
Earlier this year, I opposed RFK’s nomination because he was unfit for the role and particularly over the concern that he would… https://t.co/B1rRgkF5iO
— Mike Pence (@Mike_Pence) October 2, 2025
In a series of posts on X, Sen. Josh Hawley (R-MO) shared that the move reveals regulatory failures:
"This is shocking. FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother. And of course 100% lethal to the child."
This is shocking. FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother. And of course 100% lethal to the child.
— Josh Hawley (@HawleyMO) October 2, 2025
In a follow-up tweet, he wrote, "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."
Susan B. Anthony Pro-Life America President Marjorie Dannenfelser issued a statement calling for the FDA to reinstate "commonsense safeguards" that were placed during Trump's first administration:
"This reckless decision by the FDA to expand the availability of abortion drugs is unconscionable. These dangerous drugs take the lives of unborn children, place women and underage girls at serious risk, empower abusers, and trample the pro-life laws enacted by states across the nation."
Pro-life advocates point out how dangerous the drug is for moms and their unborn babies.
Lila Rose, President of Live Action, wrote on X, "UNACCEPTABLE: The FDA just approved another generic of the abortion pill Mifepristone. This drug starves babies and harms mothers! The FDA just said it would do a new serious safety study—so why approve another generic now? @RobertKennedyJr must reverse this decision."
Students for Life for America, a pro-life advocacy group, explains bluntly that the drug kills people.
"It kills people on purpose and sometimes by accident. It exposes women to injury and infertility. It's an abuser's dream drug. Oh, and abortion water pollution. Your failure to start the evaluation doesn't justify allowing more on the market," it wrote in a statement to the FDA on X.
According to Evita's website, its mission is to "normalize abortion" and make it "accessible to all."
Andrew Nixon, a spokesperson for the Health and Human Services Department, told NBC the FDA does not endorse drug products and directs prescribers to follow all labeling.
"The FDA has very limited discretion in deciding whether to approve a generic drug. By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug," Nixon said in a statement.
"Generic applicants are not required to submit independent evidence proving safety and effectiveness," he added. "HHS is conducting a study of the reported adverse effects of mifepristone to ensure the FDA's risk mitigation program for the drug is sufficient to protect women from unstated risks."
In a separate post on X, Kennedy argued: "The Biden administration removed mifepristone's in-person dispensing rule without studying the safety risks. We are filling that gap."
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