Comment from Arkansas Right to Life

Dear Comissionary Makary, Arkansas Right To Life opposes citizen petition FDA-2025-P-0377-0001. We urge the FDA not to remove the remaining Risk Evaluation and Mitigation Strategies (REMS) on mifepristone, and to reinstate prior safety standards, including in-person dispensing as well as follow up, reporting of ALL adverse events, and limiting use to 7 weeks gestation. Unrestricted access to mifepristone without an in-person physician visit to include an ultraound poses serious risk of harm to women. Mail order access to mifepristone creates opportunity for malintentioned individuals to obtain the drug and administer it to a pregnant woman against her will or without her knowledge. It is our belief that human life begins at conception and that the use of mifepristone for pregnancy termination should be limited only to those cases when maternal-fetal separation is necessary to protect the life of the mother. Such a serious undertaking should only be done under the supervision of a qualified physician, who is prepared to handle the known potential complications, including bleeding, hemorrhage, sepsis, surgical evacuation of the uterus, and emergency hysterectomy. We believe that all women deserve the best care and the best information about their care. An in person consultation with a physician, physical exam, and ultrasound are required before a woman can truly give informed consent for a pregnancy termination. The citizen petition put forth by ACOG inexplicably, ignores their own guidelines recommending first trimester ultrasound to confirm pregnancy dating, making it clear that ACOG is acting as a political entity rather than a scientific one. Their willingness to put women in danger is baffling. We urge the FDA to protect women by restricting access to mifepristone. Sincerely, Sharai Amaya MD BOARD PRESIDENT OF ARKANSAS RIGHT TO LIFE