Attorney General Tong Petitions the FDA to Remove Burdensome Restrictions on Mifepristone

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08/21/2025

Attorney General Tong Petitions the FDA to Remove Burdensome Restrictions on Mifepristone

(Hartford, CT) -- Attorney General William Tong, 16 other attorneys general and the governor of Pennsylvania this week petitioned the U.S. Food and Drug Administration (FDA) to remove burdensome restrictions on mifepristone, one of two drugs used in medication abortions, the most common means of abortion in the United States.

The coalition on Wednesday submitted extensive evidence on the safety of medication abortion as well as the burdens imposed by the FDA’s continued restrictions on mifepristone. In the filing, the states join and supplement a citizen petition filed with the FDA by Massachusetts, California, New Jersey, and New York on June 5. 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.

“Mifepristone is safe, legal and effective. Burdensome restrictions imposed by the FDA are about politics, not patient safety, and the extensive evidence we submitted this week demonstrates that. We’re going to keep fighting on every possible front to protect the rights of women and patients to make decisions free from needless political interference,” said Attorney General Tong.

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.

And yet, 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 and mislead pregnant patients regarding the safety of medication abortion.

In the filing, Attorney General Tong requests 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.

Attorney General Tong has taken numerous actions in courts across the country to preserve access to medication abortion, including joining 17 attorneys general in Washington federal court challenging other unnecessary and severe restrictions still imposed by the FDA. That case concluded in July, but the fight to ensure patients have access to medication abortion continues today. Mifepristone remains safe and accessible in Connecticut. Attorney General Tong has issued Formal Opinion 2023-03 clarifying the status of the abortion drug mifepristone, in light of various federal court rulings.

Joining Attorney General Tong in submitting the petition to the FDA are the attorneys general of Arizona, Colorado, Delaware, Hawai‘i, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Rhode Island, Vermont, the District of Columbia, Washington, and Pennsylvania Governor Josh Shapiro, on behalf of the Commonwealth of Pennsylvania.

Twitter: @AGWilliamTong

Facebook: CT Attorney General

Media Contact:

Elizabeth Benton
elizabeth.benton@ct.gov

Consumer Inquiries:

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attorney.general@ct.gov