Statement | Healthy America

AFPI Opposes FDA Approval of Generic Abortion Drug

October 3, 2025

Washington D.C.— Recently, the U.S. Food and Drug Administration (FDA) approved the second generic version of the abortion drug known as mifepristone. The America First Policy Institute (AFPI) issued the following statement in response:

“President Trump has been the greatest ally of the pro-life movement to ever grace the Oval Office. He was the first U.S. President to attend the March for Life and, among other things, has recently championed unborn human life by ending abortion funding domestically and overseas.”

“While we are grateful for the excellent work the FDA has done under President Trump’s leadership in recent months to make Americans safer and improve the quality of our food products and medicines, we are disappointed and concerned that the FDA approved a second generic version of the dangerous drug mifepristone, especially considering the FDA’s promised re-review of the safety data has not been completed.”

“It was the Obama and Biden administrations that stripped safeguards and allowed for mifepristone to be prescribed later in a woman’s pregnancy, received in the mail, and prescribed through telemedicine. Women deserve better than the recklessness of past presidents, and the FDA should work to ensure all the medicine they approve is safe. Mifepristone has been shown to be dangerous to women and is unworthy of broader distribution.”

“A letter sent from Secretary Kennedy to state attorneys general stated that ‘the FDA has received reports of serious adverse events in patients who took mifepristone.’ The FDA collected data from 2000 to 2012 that ‘indicated 2,740 adverse events, including 416 events involving blood loss requiring transfusions.’ The risk of this drug to women is too high. Other studies have also found mifepristone to be dangerous to women's health, sometimes causing death or serious medical complications.”

“Secretary Kennedy also explained that the Biden Administration had a pattern of neglecting the evidence that these drugs were harming women. Women have been lied to and told that chemical abortions are as safe as common medications like penicillin. Immediate action is needed to protect women.”

“Earlier this year, AFPI applauded the Secretary’s commitment to making American women healthy again by reviewing the safety concerns and his promise to do a thorough safety review of chemical abortion drugs like mifepristone.”

“Now, we urgently call on Secretary Kennedy and Commissioner Makary to complete the re-review of the safety data within the next 90 days and reapply the safety requirements under the Risk Evaluation Mitigation Strategy (REMS) to mifepristone, including the generic versions. If it is once again shown that mifepristone is dangerous, the drug should be restricted accordingly.”

“AFPI will conduct a study of women who are negatively impacted by this drug and demonstrate how the liberal abortion agenda of recklessly expanding telehealth abortion facilitation and mail-order abortion drugs are harming women and girls.”

Join The
Movement



By providing your information, you become a member of America First Policy Institute and consent to receive emails. By checking the opt in box, you consent to receive recurring SMS/MMS messages. Message and data rates may apply. Message frequency varies. Text STOP to opt-out or HELP for help. SMS opt in will not be sold, rented, or shared. View our Privacy Policy and Mobile Terms of Service.