Senators Hassan, Shaheen Urge Drug Manufacturer to Update Medication Label to Protect Women Experiencing Early-Pregnancy Miscarriage
WASHINGTON – U.S. Senators Maggie Hassan (D-NH), Mazie K. Hirono (D-HI), and Elizabeth Warren (D-MA) led a push joined by Senator Jeanne Shaheen (D-NH) urging Danco Laboratories, a manufacturer of mifepristone – which is safely and legally used to manage miscarriages –to submit an application to the Food and Drug Administration (FDA) to add miscarriage management to the medication’s label. The label currently only includes medication abortion.
The push comes as many women experiencing early-pregnancy miscarriage are facing barriers to accessing this critical drug because of state efforts to ban abortions, including medication abortion. Updating mifepristone’s label would ensure health care providers can prescribe the drug for miscarriage management without fear of criminal action and will ensure that women can access the most safe and effective treatment for miscarriage.
“People experiencing miscarriage deserve access to safe and effective treatment, without added and unnecessary pain,” wrote the Senators. “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.”
Senator Hassan has been a leader in standing up for women’s reproductive freedoms and an outspoken advocate on the dangerous consequences of the Supreme Court’s decision to overturn Roe. Senator Hassan has also been a leader in the fight to protect Title X family planning centers.
Senator Shaheen is an unrelenting advocate for women’s reproductive rights. As it became clear last fall that the Supreme Court would likely overturn Roe, Shaheen held a press conference with the New Hampshire delegation and Planned Parenthood of Northern New England to discuss women’s freedoms and the implications for reproductive health with the overturning of Roe v. Wade. She later spoke on the Senate floor to urge lawmakers to vote in favor of legislation that would codify Roe. For years, Shaheen has fought to expand coverage of women’s preventative care, including through her legislation to reduce the cost of contraception for servicewomen and dependents in military families. She also penned an op-ed for the Union Leader underscoring the threats to women’s freedoms and rights in a post-Roe America. It can be read in full here.
Read the full text of the letter here or below.
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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