U.S. Senator Kirsten Gillibrand joined 7 of her 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. Following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, a number of states have restricted or banned medication abortion, which requires the use of mifepristone. However, mifepristone is also used as a safe and effective treatment for women experiencing early-pregnancy miscarriage. Because miscarriage management is not listed as an indication on the label, health care providers’ ability to prescribe it for miscarriage management is limited. Gillibrand and her colleagues are urging Danco Laboratories to update mifepristone’s label to help ensure that women experiencing a miscarriage have access to this treatment.
“Health care providers need to be able to prescribe the best course of treatment for their patients without fear of prosecution,” said Senator Gillibrand. “Mifepristone is shown to be a safe and effective way to treat the hundreds of thousands American women who suffer miscarriages every year, and highly restrictive laws should not impede its use. I urge Danco Laboratories to quickly seek approval from the FDA to add miscarriage management to the mifepristone label.”
The letter was also signed by Senators Mazie Hirono (D-HI), Maggie Hassan (D-NH), Elizabeth Warren (D-MA), Richard Blumenthal (D-CT), Jeanne Shaheen (D-NH), Ron Wyden (D-OR), and Alex Padilla (D-CA).
The full text of the letter is available 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.