The U.S. Food and Drug Administration recently approved a second generic version of mifepristone, a drug used in combination with misoprostol for medication abortion up to 70 days of gestation.
The approval, which allows a lower-cost option for abortion care, comes as the Department of Health and Human Services (HHS) studies reported adverse effects to evaluate the FDA’s risk mitigation program.
Unlike typical significant drug approvals, the FDA did not issue a press release, drawing attention from both supporters and critics of the decision.
Mifepristone, which blocks progesterone to end a pregnancy, and misoprostol, which induces contractions, have been deemed safe and effective by peer-reviewed research, with serious adverse reactions considered rare.
Brittany Fonteno, CEO of the National Abortion Federation, emphasized that the approval reinforces decades of research showing medication abortion’s safety and efficacy.
The drug’s expanded use, enabled by 2016 and 2021 rule changes allowing use up to 10 weeks and telehealth prescribing, has made it accessible to millions.
The approval has faced strong opposition from anti-abortion groups.
Marjorie Dannenfelser, president of SBA Pro-Life America, criticized the decision, citing assurances from HHS Secretary Kennedy and FDA Commissioner Makary for a thorough safety review.
Critics point to a non-peer-reviewed report from the Ethics and Public Policy Center, which claims higher complication rates than FDA data.
Reproductive health experts have dismissed the report as unreliable.
In July, 22 Republican attorneys general urged Kennedy and Makary to scrutinize mifepristone’s safety, prompting a response last month.
Anti-abortion activists, wary of Kennedy’s past abortion rights stance, continue to push for revoking generic mifepristone approvals, intensifying the debate over its regulation.