In its ongoing efforts to increase access to reproductive health care, the Center for Reproductive Rights has joined with some of the nation’s leading medical and scientific associations, research institutions, and advocacy organizations to petition the U.S. Food and Drug Administration (FDA) to increase access to mifepristone for the treatment of miscarriages.
The citizen’s petition—led by the American College of Obstetricians and Gynecologists (ACOG)—calls on the FDA to:
- Work with the drug’s manufacturer, Danco Laboratories, to add miscarriage management to the drug’s label;
- Eliminate mifepristone’s unduly burdensome Risk Evaluation and Mitigation Strategy (REMS), which restricts who can prescribe the medication; and
- Immediately exercise enforcement discretion so that providers can offer mifepristone for miscarriage management care.
Mifepristone is currently labeled for use in medication abortion, but not miscarriage management—even though scientific evidence supports mifepristone for treating miscarriages. When mifepristone is used in combination with misoprostol—a drug that has become the standard treatment for miscarriages—it is more effective than misoprostol used alone to safely and effectively complete an early miscarriage without a medical procedure.
Politically Imposed Barriers Have Increased Since Roe Was Struck Down
Since the Supreme Court overturned Roe v. Wade and took away the constitutional right to abortion in June, anti-abortion lawmakers have rushed to enforce abortion bans—and abortion is now illegal in 13 states. Increasingly, patients, providers, and pharmacists have feared legal risks of managing or helping someone manage a miscarriage, including possible imprisonment and the loss of their professional licenses.
“People experiencing a miscarriage should have access to the full range of safe and effective treatment options—and their providers should not have to risk imprisonment for simply providing medical care to their patients,” said Jenny Ma, senior staff attorney at the Center. “We call on the FDA to take action now to eliminate unnecessary legal barriers so more health care providers can offer safe, effective options for miscarriage care without fear.”
Miscarriage affects people of every age, race/ethnicity, and socioeconomic status, but is more common among groups negatively impacted by societal dynamics of power and oppression, such as pregnant people who are Black, poor, or exposed to environmental pollutants.
Promoting access to mifepristone as part of miscarriage management care expands patient choice and ensures access to the safest and most effective treatments regardless of geographic location, race, ethnicity, and socioeconomic status.