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Shaheen, Senators Send Letter Urging Drug Manufacturer to Update Medication Label to Protect Women Experiencing Early-Pregnancy Miscarriage

(Washington, DC) – U.S. Senator Jeanne Shaheen (D-NH) and a group of Senators sent 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. Currently, mifepristone’s label includes medication abortion, but it can also be safely and legally used for miscarriage management.  

As many states are trying to limit the use of medication abortion, women experiencing early-pregnancy miscarriage are facing barriers to accessing this critical drug because the phrase “miscarriage management” is not included on the label. Updating mifepristone’s label would make the medication accessible for miscarriage management without fear of criminal action against health care providers, as well as 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,” wrote 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.” 

After the reversal of Roe v. Wade, many states 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. 

The letter was led by Senators Mazie K. Hirono (D-HI), Maggie Hassan (D-NH) and Elizabeth Warren (D-MA) and also signed by Senators Richard Blumenthal (D-CT), 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 available here. 

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.