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4 States Ask FDA to Lift Rules on Abortion Pill Mifepristone

By I. Edwards HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on June 6, 2025.

FRIDAY, June 6, 2025 — Attorneys general from four states are asking the U.S. Food and Drug Administration (FDA) to lift restrictions on mifepristone, a pill used in medication abortions.

The request came Thursday from top officials in California, Massachusetts, New Jersey and New York.

They said in a petition that the current rules make it too hard for doctors to prescribe the pill — even though studies show it is safe, NBC News reported.

“Given mifepristone’s 25-year safety record, there is simply no scientific or medical reason to subject it to such extraordinary restrictions,” New York Attorney General Letitia James said.

Mifepristone is one of two pills used in a medication abortion and is often targeted in legal battles over abortion rights.

The FDA now includes mifepristone in a special safety program called Risk Evaluation and Mitigation Strategies (REMS). This program is used for drugs that may have serious health risks, NBC News added.

As part of REMS, only certified health care providers can prescribe mifepristone, and certified pharmacies must fill the prescription. Patients must also sign a form confirming they are choosing to end their pregnancy.

The attorneys general say these rules are burdensome and deter many family doctors from offering the medication. They also say doctors worry about being added to local and national lists of abortion providers.

Studies show mifepristone is very safe. Fewer than 0.5% of people who take it have serious side effects, according to research. It is also just as safe and effective when prescribed via telehealth and sent by mail.

The states' petition comes as the FDA plans to review the safety of mifepristone. That review was requested by U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and Sen. Josh Hawley (R-Mo.).

Their concerns are based on a report that claimed to show high rates of serious side effects. But many experts say the study, which was not peer-reviewed, is junk science. It was released by a conservative group linked to Project 2025, which wants to overturn FDA approval of the drug.

Researchers who study reproductive health say the report does not meet basic research standards, uses unclear definitions and fails to identify the database studied.

Over the years, the FDA has removed some restrictions on mifepristone.

In 2016, it extended its use from seven to 10 weeks into pregnancy. In 2019, it approved a generic version of the medication. And in 2021, it allowed the pill to be prescribed via telehealth instead of requiring in-person visits.

Anti-abortion groups have tried to get those changes reversed, often pointing to studies that exaggerate risks, NBC News said.

In 2022, a group of anti-abortion organizations sued the FDA to take mifepristone off the market. They used two studies from the Charlotte Lozier Institute, an anti-abortion group.

The U.S. Supreme Court later threw out the case, and the studies were retracted by a medical publisher.

Last month, the Charlotte Lozier Institute released another report claiming emergency room visits after abortions are being mislabeled as miscarriages. Experts say the data is flawed.

“The anti-choice people are really going after medication abortion," said Rachel Jones, a scientist at the Guttmacher Institute, a group that supports abortion access.

"[They are] doing whatever they can to get the FDA under the Trump administration to revisit the availability of the drug,” she added.

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2025 HealthDay. All rights reserved.

Posted June 2025

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