U.S. Senators Urge FDA Update to Mifepristone Label for Miscarriage Use: ‘Patients Should Have Access to the Most Effective Medication Available’

Adding mifepristone is more effective for the management of miscarriage than taking misoprostol alone. But because of legal concerns about mifepristone, healthcare providers are instead prescribing high doses of misoprostol, resulting in severe cramping and “making it a longer, more dangerous and psychologically taxing process.” (Robyn Beck / AFP via Getty Images)

The drug mifepristone is widely used for abortion, but is also highly effective at treating incomplete miscarriages. While the U.S. Food and Drug Administration (FDA) has approved mifepristone for pregnancy termination, it does not explicitly label the drug for use in miscarriage care.

For years doctors have prescribed mifepristone off-label for miscarriage treatment, a practice allowable by the FDA. But now, the proliferation of new state bans and restrictions on medication abortion has raised concerns that prescribing mifepristone could lead to criminal prosecution of healthcare providers. As a result, reproductive health advocates are now urging the FDA to specifically label mifepristone for miscarriage treatment.

Last October, the American College of Obstetricians and Gynecologists, the American Medical Association and 47 other organizations representing reproductive healthcare providers, researchers and advocates filed a citizen petition urging the FDA to relabel mifepristone for miscarriage treatment. In early January, the FDA rejected the petition, stating that the drug manufacturers would have to submit an application to change the label.

On Feb. 1, eight U.S. senators, led by Mazie K. Hirono (D-Hawaii), Maggie Hassan (D-N.H.) and Elizabeth Warren (D-Mass.) sent an open letter to Danco Laboratories, which makes the brand name mifepristone Mifeprex, urging them to submit an application to the FDA to add miscarriage management to the medication’s label. The letter was also signed by Sens. Richard Blumenthal (D-Conn.), Jeanne Shaheen (D-N.H.), Ron Wyden (D-Ore.), Kirsten Gillibrand (D-N.Y.) and Alex Padilla (D-Calif.).

“Currently, access to abortion has been restricted, or will likely be restricted, in 24 states. Not only do these laws take away the reproductive rights of women, but they also endanger the lives of people experiencing early-pregnancy miscarriage,” said the senators.

Because of legal concerns about mifepristone, they noted, healthcare providers are instead prescribing high doses of misoprostol to ensure effectiveness, resulting in severe cramping, “making it a longer, more dangerous and psychologically taxing process.”

“People experiencing miscarriage deserve access to safe and effective treatment, without added and unnecessary pain,” said the lawmakers. “Women in need of mifepristone for early-pregnancy miscarriages are experiencing barriers to effective and safe treatment because this drug is commonly used in medical abortions. Updating mifepristone’s label will make this drug accessible for miscarriage management without fear of criminal action against healthcare providers.”

The senators implored Danco to submit a request to the FDA to add miscarriage management as an indication to the mifepristone label.

Over one million women in America experience a miscarriage every year—as many as 26 percent of all pregnancies. Miscarriage is more common among Black and low-income women. Research shows the combination of mifepristone and misoprostol significantly improves the management of early pregnancy loss, resulting in fewer complications and reducing the likelihood of patients needing an additional procedure.

 “Patients experiencing an early miscarriage should have access to the most effective medication available,” said Kirsten Moore, executive director of Expanding Medication Abortion Access (EMAA) Project. “Given the uncertain and hostile legislative climate in some states, it is vitally important to add miscarriage to the mifepristone label.” 

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Carrie N. Baker, J.D., Ph.D., is the Sylvia Dlugasch Bauman professor of American Studies and the chair of the Program for the Study of Women and Gender at Smith College. She is a contributing editor at Ms. magazine. You can contact Dr. Baker at cbaker@msmagazine.com or follow her on Twitter @CarrieNBaker.