(Washington, D.C.): Yesterday, Americans United for Life (AUL) submitted an administrative comment to the Food and Drug Administration (FDA) opposing the citizen petition by Washington, sixteen other states, and the District of Columbia, which joins the previous comment led by Massachusetts to remove the remaining Risk Evaluation and Mitigation Strategies (REMS) for the chemical abortion drug mifepristone.
The petition also alternatively asks the FDA to not enforce certain “Elements to Assure Safe Use,” including essential regulatory safeguards such as the prescriber certification, patient agreement forms, and pharmacy certification requirements which provide valuable informed consent safeguards and health and safety protections.
AUL firmly stands behind protecting women from the harms of chemical abortion drugs, asking the FDA to deny the dangerous Washington-led citizen petition and instead reestablish safeguards that have previously been stripped away, including the in-person dispensing requirement and mandated adverse event reporting for non-fatal adverse events. AUL also urges the FDA to implement an additional safeguard that requires the performance of an ultrasound before mifepristone is prescribed in order to confirm the gestational age and verify that the pregnancy is not a life-threatening ectopic pregnancy.
Carolyn McDonnell, Litigation Counsel for Americans United for Life, stated, “When the FDA approved mifepristone, it recognized that the chemical abortion drug regimen required heightened safeguards, especially since it has serious and sometimes fatal risks of bleeding or infections. The FDA should strengthen, not remove, these patient protections for women seeking a chemical abortion.”
Danielle Pimentel, Policy Counsel for Americans United for Life, emphasized, “As the FDA’s own data and recent studies have shown, chemical abortion drugs have severely endangered pregnant women. The FDA should deny Washington’s citizen petition, which seeks the removal of all of mifepristone’s safeguards. Such reckless requests will only lead to more women being harmed by unregulated, dangerous drugs.”
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.
