AG Brown petitions the FDA to remove burdensome restrictions on mifepristone

SEATTLE – Attorney General Nick Brown and 16 other states, as well as the District of Columbia, are requesting 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.

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.

“Mifepristone has been safely used by millions of women in this country over the last 25 years,” Brown said. “In a post-Dobbs world, we should be removing unnecessary barriers to reproductive health care in states that protect abortion so people have the freedom to plan when and whether to have a family.”

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.

Data compiled by the Washington State Department of Health shows that of the nearly 30,000 medication abortions provided in Washington in 2023 and 2024, the overwhelming majority had no complications, and fewer than 0.2% resulted in a complication severe enough to warrant hospitalization.

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 declarations from Washington included with the filing, physicians say that the current registration requirement leaves providers feeling vulnerable to possible attacks by anti-abortion activists. The requirement serves as a disincentive, resulting in a reduced number of providers able to prescribe medication abortion, particularly in rural areas already contending with limited health care options.

In today’s filing, Brown 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.

In Washington, Assistant Attorney General Lauryn Fraas, Wing Luke Civil Rights Division Chief Colleen Melody, Deputy Solicitor General Tera Heintz, and Paralegals Jennah Williams and Nicole Beck-Thorne have handled the citizen petition.

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

A copy of the petition is available here.

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