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www.fdanews.com/articles/211075-lawmakers-push-abortion-pill-maker-to-change-labeling-to-allow-use-for-miscarriages

Lawmakers Push Abortion Pill Maker to Change Labeling to Allow Use for Miscarriages

February 7, 2023

Senate Democrats are pressing one of the makers of the abortion pill mifepristone to change the drug’s label to make it easier for patients undergoing a miscarriage to get the drug.

Headed by Sens. Mazie Hirono (Hawaii), Elizabeth Warren (Mass.) and Maggie Hassan (N.H.), the group is pressing Danco Laboratories to file an application with the FDA to add miscarriage management to mifepristone’s label.

The label now only includes medication abortion.

Last month, the FDA rejected a citizen petition from the American College of Obstetricians and Gynecologists (ACOG) and 48 other organizations that asked for a miscarriage indication to be added the drug’s label.

The FDA responded that only the maker of the drug can decide if it wants to submit such an application along with required safety and efficiency data to support the new indication. 

In January, the FDA removed restrictions on access that allow women to get the abortion pill at their pharmacy instead of in a healthcare setting, and changed a requirement that the pill needs to be picked up in person. As of Jan. 3, it can be mailed.

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