US Senator urges drug manufacturer to update medication label

WASHINGTON, D.C. -UNS: 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).

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