FDA Commissioner Marty Makary promised to conduct a full review on the harms of mifepristone. Given what we know concerning the harms to the unborn and women’s health and lives when mifepristone is ingested, it is imperative that mifepristone is reviewed as has been promised. Recently, however, to our disappointment and great concern, the FDA quietly approved a new generic version of mifepristone. In addition to ending countless unborn lives, this abortion drug puts women and girls at serious risk. It is unclear why this happened.

In his stated commitment to follow the science to ensure the safety and well-being of women and unborn children alike, we ask that the FDA remove this generic version of mifepristone from the market and conduct the full review on mifepristone. We also urge the FDA to immediately reinstate reporting of ALL adverse events related to mifepristone use and reinstate the pre-2016 Risk Evaluation and Mitigation Strategies (REMS), including limiting use of the drug to seven weeks gestation and requiring in-person dispensing as well as follow up. We also urge the FDA to require ultrasounds to confirm gestational age (crucial to accurately dating a pregnancy and determining the risk of complications) and to rule out ectopic pregnancy, which is a life-threatening condition.