This week, the U.S. Food and Drug Administration approved a new generic version of the dangerous abortion pill Mifepristone that could increase both the number of babies killed by abortions as well as medical complications for women.

The approval allows telehealth company Evita Solutions, which has a purported mission to “normalize abortion” and make it “accessible to all,” to manufacture the new generic version of Danco Laboratories’ harmful drug Mifepristone. Mifepristone is currently marketed under the brand name Mifeprex that comes with the FDA’s strongest warning for drugs with major health risks—a “black box warning” that includes potential for heavy bleeding, infection, and incomplete abortion, which may necessitate surgical intervention. Recent studies show that nearly 11 percent of women are harmed after just one dose of this harmful drug.

In a September 30 letter, the FDA told Evita Solutions that its generic 200 mg Mifepristone tablets were “bioequivalent and therapeutically equivalent” to Mifeprex.

The approval marks the second time that the FDA has given the green light to a generic abortion pill since it approved GENBIOPRO’s version in 2019. Since Mifepristone’s original approval in 2000, chemical abortion drugs have become the most common early-term abortion method accounting for at least 63 percent of all abortions nationwide despite the health risks. 

U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., who oversees the FDA, stated on social media that the FDA only approved the new generic pill “because federal law requires approval when an application proves the generic is identical to the brand-name drug.” 

However, on September 19, Secretary Kennedy and FDA Director Dr. Martin Makary acknowledged that recent studies have raised “concerns about the safety of Mifepristone” whereby the FDA committed to “conducting its own review of the evidence.” Secretary Kennedy and Director Makary made this announcement of a new Mifepristone safety review in a response letter to 22 state attorneys general who had asked the FDA to restore abortion pill safety standards that had been incrementally removed under the Biden administration.

“…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,” reads the letter. “This review will help ensure that the FDA's decisions are grounded in Gold Standard Science and rigorous, transparent, and objective evidence.” 

Liberty Counsel Founder and Chairman Mat Staver said, “A new generic abortion drug will increase chemical abortions that harm women physically and emotionally and cruelly kill defenseless children in the womb. The FDA needs to review the evidence that shows Mifepristone is dangerous and then remove the drug from the market. The FDA needs a complete overhaul and a return to sound science.”