Study finds patient agreement forms match knowledge surveys, urging greater transparency in FDA’s mifepristone REMS

A randomized controlled trial published in JAMA Internal Medicine examined how well patients understood medication abortion when they signed the FDA’s risk evaluation and mitigation strategy (REMS) patient agreement form (PAF) for mifepristone and misoprostol. The study compared these patients with a group that completed a knowledge survey before reviewing and signing the PAF.

Results showed that both groups were equally knowledgeable about medication abortion, indicating that the PAF does not diminish patient understanding. However, the authors argue that the findings highlight gaps in data collection and transparency within the REMS program.

The researchers call for more robust monitoring and clearer reporting mechanisms to ensure the REMS program effectively safeguards patient safety while maintaining access to the medication.

These insights may inform future regulatory adjustments and encourage stakeholders to improve data sharing practices around FDA‑mandated risk mitigation strategies.