Attorney General Tong Petitions FDA to Remove Burdensome Restrictions on Mifepristone

Strategic Insights -

Attorney General William Tong, along with 16 other attorneys general and Pennsylvania Governor Josh Shapiro, has submitted a petition to the U.S. Food and Drug Administration (FDA) to remove burdensome restrictions on mifepristone, a medication used in medication abortions. The coalition argues that the FDA's continued restrictions on mifepristone are not warranted by its safety record and unfairly burden patient access, particularly in rural and medically underserved areas.

Key Takeaways:

  • The petition, submitted on August 21, joins a citizen petition filed by Massachusetts, California, New Jersey, and New York on June 5, and urges the FDA to eliminate unnecessary restrictions on mifepristone.
  • The coalition argues that the FDA's restrictions on mifepristone, which include requiring providers to become registered prescribers, pharmacies to obtain special certification to dispense the drug, and patients to sign a form agreeing to voluntarily terminate their pregnancy, are unduly burdensome and discourage medical professionals from providing medication abortion.
  • Since receiving FDA approval in 2000, more than 7.5 million women in the U.S. have safely used mifepristone for abortion care or miscarriage management.
  • The coalition requests that the FDA remove these onerous restrictions on mifepristone or, alternatively, stop enforcing them 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 and has issued a Formal Opinion clarifying the status of the abortion drug mifepristone in light of various federal court rulings.

Statistics:

  • More than 7.5 million women in the U.S. have safely used mifepristone for abortion care or miscarriage management since its initial FDA approval in 2000.
  • The petition to remove burdensome restrictions on mifepristone was submitted on August 21 by a coalition of 17 attorneys general and Pennsylvania Governor Josh Shapiro.
  • The coalition argues that the FDA's restrictions on mifepristone, which apply to almost no other regulated drugs, discourage medical professionals from providing medication abortion.

Sources:

  • Connecticut Attorney General's Office, "Attorney General Tong Petitions the FDA to Remove Burdensome Restrictions on Mifepristone" (August 21) [1]
  • FDA, "Label: Mifepristone - Kit" [2]
  • Guttmacher Institute, "Medication abortion in the United States: History and current status" (2020) [3]