Arizona Attorney General Urges FDA to Remove Restrictions on Mifepristone

Attorney General Kris Mayes of Arizona, along with 16 other states and the District of Columbia, has submitted a filing to the US Food and Drug Administration (FDA) urging the agency to remove burdensome restrictions on mifepristone, a medication used in abortion care. The coalition argues that the FDA's continued restrictions on mifepristone are unnecessary and unduly burden patient access. Despite the safety and efficacy of medication abortion being well-established by hundreds of scientific studies, the FDA has set restrictions on the drug that require providers to become registered prescribers, pharmacies to obtain special certification, and patients to sign a form agreeing to terminate their pregnancy.

Key Takeaways:

• The coalition's filing presents extensive evidence on the safety of medication abortion in their states and the burdens imposed by the FDA's continued restrictions on 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.
• More than 7.5 million women in the U.S. have safely used mifepristone for abortion care or miscarriage management.
• A combination of mifepristone and misoprostol was prescribed for 99.7% of Arizonans seeking medication abortion care or miscarriage management in 2023.
• The FDA's restrictions on mifepristone require providers to become a registered prescriber, pharmacies to obtain special certification, and patients to sign a form agreeing to terminate their pregnancy.
• The coalition requests that the FDA finally remove these onerous and unnecessary restrictions on mifepristone or stop enforcing the requirements in their states.

Statistics:

• More than 7.5 million women in the U.S. have safely used mifepristone for abortion care or miscarriage management.
• A combination of mifepristone and misoprostol was prescribed for 99.7% of Arizonans seeking medication abortion care or miscarriage management in 2023.
• The coalition consists of 18 states and the District of Columbia, including Arizona, Colorado, Connecticut, Delaware, Hawai'i, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Rhode Island, Vermont, the District of Columbia, Washington, and Pennsylvania.

Sources:

• Release from the office of the Arizona Attorney General.
• US Supreme Court Decision in Food and Drug Administration vs. Alliance for Hippocratic Medicine.
• [1] Office of Arizona Attorney General.
• [2] FDA approval of mifepristone (2000).
• [3] Report on medication abortion safety (hundreds of scientific studies).