FOR IMMEDIATE RELEASE
August 6th, 2025
(Washington, D.C.): Last week, Americans United for Life (AUL) submitted two administrative comments to the Food and Drug Administration (FDA) opposing pro-abortion citizen petitions by the State of Massachusetts and GenBioPro, manufacturer of the generic form of the abortion drug, mifepristone.
AUL firmly stands behind protecting women from the harms of chemical abortion drugs and has asked the FDA to deny their petitions. Together, the petitions ask the FDA to remove the Risk Evaluation and Mitigation Strategies (REMS) from the mifepristone approval or, alternatively, refrain from enforcing the Elements to Assure Safe Use provisions in the petitioner states and refrain from implementing new or previously rescinded patient safeguards.
AUL also urges the FDA to implement additional safeguards that require the performance of an ultrasound before mifepristone is prescribed in order to confirm gestational age and verify that the pregnancy is not a life-threatening ectopic pregnancy.
Carolyn McDonnell, Litigation Counsel for Americans United for Life, stated, “Instead of removing or keeping inadequate safeguards on mifepristone, we urge the FDA to restore critical patient protections, including the adverse event reporting for non-fatalities and in-person dispensing requirement. These safeguards will defend patient safety and ensure that distribution of the drugs aligns with federal law’s restrictions on mailing or shipping abortifacient matter.”
Danielle Pimentel, Policy Counsel for Americans United for Life, emphasized, “After numerous women have died and thousands have suffered severe complications from mifepristone, these citizen petitions astonishingly ask the FDA to remove or only keep the minimum, insufficient safeguards on mifepristone. The FDA must deny these ill-conceived requests, which will only lead to more women harmed. Now is the time for the FDA to reinstate and strengthen mifepristone’s safeguards, not abandon women to dangerous, unregulated drugs.”
Read the comments for the Massachusetts and GenBioPro petitions.
For more information or to arrange an interview with AUL, contact Gavin Oxley at press@aul.org or 202-987-3321.
Since 1971, Americans United for Life (AUL) has advanced the human right to life in culture, law, and policy by equipping advocates and lawmakers with the facts and strategies that change hearts and minds and protect human life. The first national pro-life organization in the country, AUL is a nonprofit, public-interest law and policy organization with a four-star rating from Charity Navigator.
