PHOENIX — Attorney General Kris Mayes and 16 other states, as well as the District of Columbia, are urging the U.S. Food and Drug Administration (FDA) remove burdensome restrictions on mifepristone, one of two drugs used in medication abortions, the most common means of abortion in the U.S.
"Women in Arizona have used Mifepristone safely and effectively for more than two decades. The FDA is folding to anti-abortion politicians and activists," said Attorney General Mayes. "The FDA should immediately remove these unnecessary restrictions and allow Arizonans to access the reproductive healthcare they have a right to. I will never stop fighting to uphold the will of the voters and ensure every Arizonan has the right to make their own decisions about their healthcare and family."
The coalition today submitted a filing presenting 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. In today’s 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.
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 Arizona, a combination of mifepristone and misoprostol was prescribed for 99.7% of Arizonans seeking medication abortion care or miscarriage management in 2023.
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.
In today’s filing, Attorney General Mayes and the coalition of attorneys general 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.
Joining Arizona in submitting the petition to the FDA are Colorado, Connecticut, 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.
Since taking office, Attorney General Mayes has fought to preserve access to medication abortion, including as a plaintiff alongside 16 other states and the District of Columbia in a federal lawsuit in Washington state to protect access to mifepristone. In April 2023, the court in the Eastern District of Washington enjoined the FDA from restricting access to the drug in Arizona and other plaintiff states. The Arizona Attorney General's Office also filed an amicus brief in the case decided by the US Supreme Court last year upholding access to Mifepristone, US Supreme Court Decision in Food and Drug Administration vs. Alliance for Hippocratic Medicine.
A copy of the filing is available here.
