Four Democratic-controlled states seek FDA to remove limitations on the abortion pill
In a significant move, the attorneys general of New York, New Jersey, Massachusetts, and California have filed a petition with the Food and Drug Administration (FDA) to remove remaining restrictions on the abortion pill mifepristone. This petition challenges the FDA's existing Risk Evaluation and Mitigation Strategy (REMS) which imposes certification requirements on pharmacies dispensing mifepristone.
The states argue that mifepristone, a medication used in combination with misoprostol to terminate a pregnancy within 10 weeks of gestation, is safe and effective. Since its approval in 2000, more than 7.5 million American women have safely used mifepristone, and in 2023, medication abortions account for more than half (63%) of all abortions in the U.S.
The petition asserts that the extensive evidence supporting mifepristone's safety and efficacy warrants the lifting of restrictions. The move aims to make access easier, especially through pharmacies without the need for special certification, thus expanding availability.
If the FDA declines to remove REMS, the petition asks the agency not to enforce some or all of the restrictions in these states, as they already have "rigorous restrictions" around the practice of medicine. California Attorney General Rob Bonta stated that mifepristone is a crucial healthcare option, especially for low-income women and those living in rural and underserved areas.
The push to lift restrictions is not new. Leading medical organizations have called on the FDA to remove REMS restrictions on mifepristone for years. However, the current environment following the Supreme Court's overturning of Roe v. Wade has made medication abortion via telehealth and pharmacy access more critical. Since the overturning, 17 states have banned medication abortions, and an additional 10 states have placed restrictions on them.
The petition is not without opposition. Health and Human Services Secretary Robert F. Kennedy Jr. ordered a safety review of the abortion pill in May. Despite this, the petition reflects confidence among abortion rights supporters that the drug’s safety profile justifies easing restrictions.
This petition is a current and active effort as of June 2025. Seventeen other Democratic-led or -leaning states, plus Washington D.C., are also suing the FDA to loosen restrictions on mifepristone. The outcome of this petition could significantly impact the availability and accessibility of medication abortions in the U.S.
- The ongoing petition, filed by the attorneys general of several states, seeks to remove the remaining restrictions on the abortion pill mifepristone, arguing that its safety and efficacy are well-established due to extensive scientific evidence.
- Since its approval in 2000, mifepristone, a critical healthcare option particularly for low-income women and those in rural areas, has been used safely by over 7.5 million American women.
- In the context of the recent Supreme Court decision overturning Roe v. Wade and subsequent state bans and restrictions on medication abortions, the petition to lift FDA restrictions on mifepristone is gaining momentum and significance.
- Notably, leading medical organizations have been advocating for the removal of REMS restrictions on mifepristone for years, citing its safety and the need for expanded access through pharmacies and telehealth.
- The current policy-and-legislation environment surrounding women's health and general news is closely focused on this petition and the future accessibility of medication abortions in the United States.
