Hirono, Hassan, Warren Lead Senate Colleagues in Urging Drug Manufacturer to Update Medication Label to Protect Women Experiencing Early-Pregnancy Miscarriage

WASHINGTON, D.C. – U.S. Senators Mazie K. Hirono (D-HI), Maggie Hassan (D-NH), and Elizabeth Warren (D-MA) led 5 of their Senate colleagues in sending a letter to Danco Laboratories, a manufacturer of mifepristone, urging them to submit an application to the Food and Drug Administration (FDA) to add miscarriage management to the medication’s label—which currently only includes medication abortion but can also be safely and legally used for miscarriage management. Given that many states are trying to limit the use of medication abortion, women experiencing early-pregnancy miscarriage are facing barriers to accessing this critical drug due to the fact that “miscarriage management” is not included on the label of the drug. Updating mifepristone’s label would make this drug accessible for miscarriage management without fear of criminal action against health care providers and will ensure women can access the most safe and effective treatment for miscarriage.  

“Following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, the reproductive rights of all Americans are under attack,” write the lawmakers. “Currently, access to abortion has been restricted, or will likely be restricted, in twenty-four 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.”

Following the reversal of Roe v. Wade, many states have restricted—and sometimes fully banned—the use of medication abortion. Due to these new restrictions, health care providers are limited in their ability to prescribe mifepristone for miscarriage management because of the drug’s current labelling. As a result, patients experiencing early-pregnancy miscarriages who need mifepristone cannot easily access the medication, placing them at risk of serious injury and death.

“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,” continued the lawmakers. “Updating mifepristone’s label will make this drug accessible for miscarriage management without fear of criminal action against health care providers.”

Last year, 49 organizations submitted a petition to the FDA requesting that the agency ask Danco and GenBioPro to submit a supplemental new drug application that seeks to add miscarriage management to the medication’s label. The FDA rejected this petition and responded that the agency would wait for the drug manufacturers to decide when to submit the application.

“Over a million women in America experience a miscarriage every year. People experiencing miscarriage deserve access to safe and effective treatment, without added and unnecessary pain,” concluded the lawmakers.

In addition to Senators Hirono, Hassan, and Warren, the letter was also signed by Senators Richard Blumenthal (D-CT), Jeanne Shaheen (D-NH), Ron Wyden (D-OR), Kirsten Gillibrand (D-NY), and Alex Padilla (D-CA). The letter is also supported by the EMAA project.

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

The full text of the letter is below and can be downloaded here.

Danco Laboratories, LLC

P.O. Box 4816

New York, NY  10185

To the Senior Leadership and Board of Directors of Danco Laboratories, LLC:

Following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, the reproductive rights of all Americans are under attack. Currently, access to abortion has been restricted, or will likely be restricted, in twenty-four 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. 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. To open up access to this treatment option, we urge you to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) to add miscarriage management as an indication to the mifepristone label.

Following the reversal of Roe v. Wade, several states have restricted—and sometimes fully banned—medication abortion, which requires the use of mifepristone and misoprostol. However, these drugs are also used for miscarriage management. Because miscarriage management is not included as an indication to the mifepristone label, health care providers are left without clear legal guidance. As a result, patients experiencing early pregnancy loss who need mifepristone cannot easily access this critical treatment, placing them at risk of serious injury and death.

Updating mifepristone’s label will make this drug accessible for miscarriage management without fear of criminal action against health care providers. Currently, some health care providers have instead prescribed a misoprostol-only regimen for miscarriage management to avoid the issue entirely. This treatment option requires patients take high doses of misoprostol to ensure effectiveness while creating serious side effects like severe cramping as a result—making it a longer, more dangerous, and psychologically taxing process. As a holder of the approved mifepristone NDA, it is your company’s authority—and responsibility—to submit an sNDA to the FDA to formally consider adding miscarriage management as an indication to the mifepristone label. The FDA has stated that it would review such an application and meet to discuss the potential submission. 

Studies estimate that as many as 26% of all pregnancies end in miscarriage, with 80% of miscarriages occurring in the first trimester.  Miscarriage is also more common among pregnant Black people, people who earn low-incomes, and people who are exposed to environmental pollutants.  Over a million women in America experience a miscarriage every year.  People experiencing miscarriage deserve access to safe and effective treatment, without added and unnecessary pain.

Despite its well-recognized safety and efficacy, physicians are not prescribing mifepristone in cases where it would be the best treatment option for people experiencing miscarriage.  We urge you to take action and submit an sNDA to add miscarriage management to the mifepristone label, ensuring that patients experience miscarriage will not be denied access to appropriate early pregnancy loss medication.

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