Senate Democrats press maker of abortion pill to add miscarriage management to label
A group of Senate Democrats is calling on Danco Laboratories, one of the manufacturers of the abortion pill mifepristone, to update the drug’s labeling to make it easier for patients to access the drug to help reduce complications from a miscarriage.
The Democrats, led by Sens. Mazie Hirono (Hawaii), Elizabeth Warren (Mass.) and Maggie Hassan (N.H.), urged the company 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.
Since the Supreme Court’s decision overturning Roe v. Wade in June, women have increasingly turned to abortion pills if they need to terminate a pregnancy. But many states have passed laws that severely restrict or outright ban medication abortion.
Mifepristone has been approved for medication abortion since 2000, but evidence has shown it can also significantly improve the management of early pregnancy loss and result in fewer complications.
The senators wrote that since miscarriage management is not included on the mifepristone label, patients experiencing early pregnancy loss who need mifepristone don’t have easy access to the drug, putting them at risk of serious injury or death.
Patients in states that have restricted access to abortion have reported being denied medications to treat their miscarriages, as pharmacists said they feared prosecution for dispensing the drugs.
“At this time, Danco does not plan to submit an application to FDA for miscarriage management,” a company spokeswoman told The Hill.
Last month, the FDA denied a petition from the American College of Obstetricians and Gynecologists that asked for a miscarriage indication to be added.
The agency said only the drug’s manufacturer can submit an application asking for such a change in the labeling. The applicant must also show that the drug is safe and effective for a new indication.
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