Attorney General Ellison petitions FDA to remove burdensome restrictions on mifepristone

One of two drugs used in medication abortion, mifepristone has been approved for 25 years and is proven highly safe — but FDA has imposed restrictions on it under political pressure

Restrictions hit people in rural and underserved areas especially hard

August 22, 2025 (SAINT PAUL) — Minnesota Attorney General Keith Ellison has joined a multistate coalition of attorneys general and a governor in petitioning the U.S. Food and Drug Administration (FDA) to remove burdensome restrictions on mifepristone, a highly safe drug that is one of two drugs used in medication abortions, the most common means of abortion in the United States. Mifepristone has been approved for use for 25 years.

Attorney General Ellison and the coalition submitted a 55-page filing that presents extensive evidence on the safety of medication abortion in their states as well as the burdens imposed by the FDA’s continued restrictions on mifepristone. The coalition urges the agency to eliminate unnecessary restrictions on this safe medication that make it much harder for patients to access medication abortions, particularly in rural and medically underserved areas.

“Abortion care is healthcare, period. Every American should be able to make their own decisions about abortion or any kind of healthcare in the privacy of their home or medical office without any kind of interference or obstruction from politicians—from the president of the United States on down — hellbent on limiting their freedoms or those doing those politicians’ bidding,” Attorney General Ellison said. “It’s particularly galling when they have slapped unreasonable burdens on a highly effective drug with a 25-year proven history of safety. I will continue to stand unwaveringly for everyone’s freedom to make their own healthcare choices as they see fit without political pressure and bullying.”

In response to political pressure to restrict medication abortion, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. told a Senate committee in May that he had ordered the FDA to conduct a “complete review” of mifepristone. Since receiving FDA approval in 2000, the combination of mifepristone and misoprostol has been the only FDA-approved regimen to end an early pregnancy. The safety and efficacy of medication abortion are well established by hundreds of scientific studies, and more than 7.5 million women in the U.S. have safely used mifepristone for abortion care or miscarriage management.

In the petition, Attorney General Ellison highlights that in 2023, 65 percent of all abortions were medication abortions, and also highlights the many aspects of Minnesota’s health-licensing systems in state law that make the provision of medication abortion highly safe (see pp. 41-42 of the petition).

Despite this fact, the FDA has set restrictions on the drug not warranted by its long and well-documented history of safety. The FDA requirements for mifepristone unduly burden patient access by, among other things:

• Requiring providers to become a registered prescriber of mifepristone
• Requiring pharmacies to obtain special certification to dispense mifepristone
• Requiring patients to sign a form agreeing that they are voluntarily terminating their pregnancy before they can receive a mifepristone prescription

These extra and unnecessary requirements, which apply to almost no other drugs the FDA regulates, discourage medical professionals from providing medication abortion when they already have the appropriate training to administer the drug.

In today’s filing, Attorney General Ellison and the multistate coalition request that the FDA finally remove these onerous and unnecessary restrictions on mifepristone. Alternatively, they ask FDA to stop enforcing the requirements in their states because the states already have robust regulatory schemes to ensure patient safety.

The petition that Attorney General Ellison and the coalition have filed joins and supplements a citizen petition that Massachusetts, California, New Jersey, and New York filed with the FDA on June 5. Joining Attorney General Ellison in submitting the current petition to the FDA are the attorneys general of Arizona, Colorado, Connecticut, Delaware, the District of Columbia, Hawaii, Illinois, Maine, Maryland, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, and Washington, and Governor Josh Shapiro on behalf of the Commonwealth of Pennsylvania.