FDA Issues Formal REMS for Mifepristone Under FDAAA Framework

The FDA formally approves a Risk Evaluation and Mitigation Strategy for mifepristone under the authority granted by the FDA Amendments Act of 2007, replacing the informal safety protocols in place since the drug''s 2000 approval. The REMS requires in-person dispensing at certified facilities and mandates that providers sign a prescriber agreement. The formalization gives the restrictions explicit statutory grounding and creates a defined regulatory target: advocates seeking to expand access must now formally petition the FDA to modify the REMS, while opponents must block any modification. The REMS framework transforms mifepristone access into a recurring site of agency rulemaking and litigation.