Story perspectives

5th Circuit Halts FDA’s Mifepristone REMS Over Safety Gaps

5/4/2026

Summary

Story summary

The U.S. 5th Circuit Court of Appeals suspended the FDA’s 2023 REMS, ending mifepristone prescriptions because the agency stopped safety reporting and treated data gap as proof of safety.
Louisiana’s 2025 lawsuit claimed the FDA acted arbitrarily, citing 1,000 abortions and $92,000 in Medicaid costs.
The FDA said it has not studied prescribing, began a 2025 review with no completion date, and that medication abortions exceed 60 percent of U.S. abortions.

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Story summary

The U.S. 5th Circuit Court of Appeals suspended the FDA’s 2023 REMS, ending mifepristone prescriptions because the agency stopped safety reporting and treated data gap as proof of safety.
Louisiana’s 2025 lawsuit claimed the FDA acted arbitrarily, citing 1,000 abortions and $92,000 in Medicaid costs.
The FDA said it has not studied prescribing, began a 2025 review with no completion date, and that medication abortions exceed 60 percent of U.S. abortions.