Jun 26, 2019

Citizen Petition

Filed with the FDA

This past spring two prominent medical organizations filed a Citizen Petition with the Food and Drug Administration (FDA), asking it to protect women’s health from the dangerous abortion pill regimen called Mifeprex. The Petition, which you can read in its entirety here, asks the FDA to enforce the protections it created in the year 2000 to ensure women are not subjected to this drug without medical support.

The Petition summarizes elevated health risks that can occur from taking Mifeprex, including hemorrhage, incomplete abortion, a higher rate of emergency room visits after the abortion, and failure to detect ectopic pregnancy.

The Petition calls on the FDA to enforce its usage guidelines, known as REMS (Risk Evaluation and Mitigation Strategy), to protect women from these hazards. The REMS protections include such basic care as having the drug administered by a physically present and certified physician who can rule out the presence of an ectopic pregnancy.

The REMS are also designed to ensure that women or girls taking the drug have access to an emergency room if a complication occurs. Women also need to know how to file an adverse events report with the FDA, how to learn about other women’s experiences before taking this drug, and to avoid web sites that illegally offer Mifeprex and other hazardous drugs for sale online.