FDA says its abortion pill safety review will continue into next year
Summary
The Food and Drug Administration (FDA) said its safety review of mifepristone, the main abortion pill in the U.S., will continue into next year. The final report on the review is expected by March 2027, after which the FDA will decide if any new rules are needed for the drug’s use.Key Facts
- Mifepristone was first approved by the FDA in 2000 and has been confirmed safe and effective multiple times since then.
- The FDA has eased some rules for mifepristone, including allowing mail delivery and online prescriptions.
- The current safety review was ordered by Health Secretary Robert F. Kennedy Jr. and started under President Donald Trump’s administration.
- The FDA expects to finish a safety study of mifepristone by mid-December 2026.
- A full report on the review results is due by March 2027, after which changes to the drug’s rules may be made.
- Several states have sued to restrict mifepristone, arguing that mail delivery violates state abortion bans.
- The U.S. 5th Circuit Court of Appeals is currently considering one such case from Louisiana, but the Supreme Court has paused changes to the drug pamphlet until further review.
- The FDA is using large databases of medical reports to find any unknown safety issues with the drug.
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