Washington State AG Petitions FDA to Remove Burdensome Restrictions on Mifepristone

Strategic Insights -

Washington State Attorney General Nick Brown, along with 16 other states and the District of Columbia, has filed a petition with the FDA to remove burdensome restrictions on mifepristone, one of two drugs used in medication abortions. The coalition argues that these restrictions make it harder for patients to access medication abortions, particularly in rural and medically underserved areas. They point to extensive evidence of the safety of medication abortion and the burdens imposed by FDA restrictions on mifepristone.

Key Takeaways:

  • The coalition, led by Attorney General Nick Brown, has submitted a filing to the FDA requesting the removal of burdensome restrictions on mifepristone, a medication used in abortion procedures.
  • The restrictions, which include requiring providers to become registered prescribers, pharmacies to obtain special certification, and patients to sign a form agreeing to the abortion, discourage medical professionals from providing medication abortion.
  • The FDA's restrictions on mifepristone are not warranted by its long and well-documented history of safety, with over 7.5 million women in the US safely using the medication for abortion care or miscarriage management.
  • Data from 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.
  • The coalition is requesting that the FDA remove these unnecessary restrictions or stop enforcing them in their states, citing robust regulatory schemes to ensure patient safety.
  • The petition is supported by 16 other 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, and Pennsylvania Governor Josh Shapiro.

Statistics:

  • Over 7.5 million women in the US have safely used mifepristone for abortion care or miscarriage management.
  • Of the nearly 30,000 medication abortions provided in Washington in 2023 and 2024, the overwhelming majority had no complications.
  • Less than 0.2% of medication abortions provided in Washington in 2023 and 2024 resulted in a complication severe enough to warrant hospitalization.

Sources:

  • Washington State Department of Health
  • FDA approval of mifepristone in 2000
  • Citizen petition filed with the FDA by Massachusetts, California, New Jersey, and New York on June 5
  • Filing by the coalition of attorneys general requesting the removal of burdensome restrictions on mifepristone
  • Declaration from physicians in Washington included with the filing
  • Original text here: https://www.atg.wa.gov/news/news-releases/ag-brown-petitions-fda-remove-burdensome-restrictions-mifepristone