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# 4 States Want Mifepristone REMS Ended
- URL: https://www.fdaweb.com/4-states-want-mifepristone-rems-ended/
- Published: 2025-06-05T12:00:00.000Z
- Updated: 2026-09-14T15:13:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159312

In a 6/5 petition, California, Massachusetts, New Jersey, and New York are asking FDA to remove the current shared risk evaluation and mitigation strategy (REMS) program for the abortion drug mifepristone (Mifeprex and its generics) in their states. The [petition](https://www.mass.gov/doc/rems-mifepristone-citizen-petition/download?ref=fdaweb.com) says it was submitted in response to HHS secretary **Robert F. Kennedy**, Jr.’s order to FDA commissioner **Martin Makary** to conduct a complete review of the drug and its labeling requirements.

“Since FDA approved mifepristone for early-stage abortion care in 2000,” the petition says, “approximately 7.5 million Americans have safely used the medication as part of a two-drug regimen. It is the primary form of abortion care in most petitioner states and has proven to be incredibly safe and effective. Given mifepristone’s well-established, 25-year safety record, FDA’s current restrictions on mifepristone are no longer justified by science or law, particularly in the petitioner states where the right to abortion is legal, protected, and comprehensively regulated by state law.”

The states say that if FDA decides not to end the REMS in their jurisdictions, it should use enforcement discretion and not enforce the REMS program or elements of it (prescriber certification, pharmacy certification, and patient agreement form) in the four states.