The Food and Drug Administration (FDA) approved a generic form of mifepristone; one of the two medications used in most U.S. abortions.
The Evita Solutions’ generic form of the drug is the second to be approved, with the first from GenBioPro in 2019. Mifepristone is often used in combination with misoprostol to induce abortions. Nearly two-thirds of abortions in the U.S. are attributed to mifepristone.
In Texas, it is illegal to perform an abortion by administering mifepristone except in life-threatening cases - because abortion was all but outlawed in the state under a law that took effect in 2022, with a newer law to further restrict abortion-inducing medications, including those that are mailed. While mifepristone is an FDA-approved drug, Texas law prohibits dispensing or mailing it for abortion purposes.
A law passed in September 2025 builds on the state’s existing ban by targeting the mailing of abortion-inducing drugs like mifepristone. While a Supreme Court decision in 2024 upheld the legality of mifepristone access federally, it did not override Texas’s state-level abortion bans and state law allows private citizens to sue anyone who manufactures, distributes, or mails abortioninducing drugs in the state.
The FDA approval comes less than two weeks after Health and Human Services Secretary Robert F. Kennedy Jr. told Republican state attorneys general in a letter that the FDA would review mifepristone’s safety because the FDA’s past decisions to roll back restrictions on mifepristone had not been given adequate consideration. Andrew Nixon, a spokesperson for the Health and Human Services Department (HHS), said the FDA does not endorse drug products and directs prescribers to follow all labeling, stating that 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.
According to HHS, generic applicants are not required to submit independent evidence proving safety and effectiveness, adding that 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. SBA Pro-Life America president Majorie Dannenfelser criticized the speedy approval as nothing more than approval to flood the market with a cheap abortion drug.
Anti-abortion groups have been skeptical of Kennedy as were conservatives during his Senate confirmation hearing. Over the last several months 22 attorneys general have sent Kennedy and HHS letters concerning mifepristone’s safety.