Four States Urge FDA to Relax Restrictions on Mifepristone, the Abortion Pill

Attorneys general from California, Massachusetts, New Jersey, and New York have collectively petitioned the U.S. Food and Drug Administration (FDA) to lift existing restrictions on mifepristone, a medication used in abortion procedures. Their request highlights that current regulations significantly hinder healthcare providers from prescribing the drug, despite extensive evidence confirming its safety. Over the past 25 years, mifepristone has demonstrated a strong safety record, with studies indicating less than 0.5% of users experiencing serious side effects.

Currently, the FDA classifies mifepristone under the Risk Evaluation and Mitigation Strategies (REMS), a program designed for medications with substantial health risks. This classification limits prescriptions to certified providers and pharmacies, requiring patients to sign forms affirming their decision to terminate pregnancy. Critics argue that these burdensome rules discourage many general practitioners from offering the medication and create fears of professional repercussions.

The petition comes amid ongoing FDA reviews prompted by concerns raised by federal officials and conservative groups citing reports of high adverse event rates. However, many researchers dismiss these reports as flawed and unscientific, originating from non-peer-reviewed sources linked to anti-abortion organizations. Historically, the FDA has eased restrictions, extending the use period, approving generics, and allowing telehealth prescriptions. Anti-abortion groups have actively sought to reverse these regulatory relaxations, often citing exaggerated risks.

Meanwhile, the FDA's review of mifepristone’s safety is underway, following initial requests from U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and Senator Josh Hawley. Numerous studies and health authorities continue to affirm the drug’s safety and efficacy, including its suitability for remote prescriptions and mailing. Despite legal challenges and misinformation campaigns, experts agree that mifepristone remains a safe, effective option for medication abortion with decades of proven safety.

This ongoing debate underscores the importance of evidence-based policies in reproductive health, balancing safety concerns with access to essential medication. The outcome of the FDA's review could significantly impact abortion access across the country, reaffirming the need for scientific integrity in healthcare decisions.