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Doctors urge U.S. FDA to add miscarriage management to abortion pill label

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

By Ahmed Aboulenein

WASHINGTON (Reuters) — Obstetricians, gynecologists, other medical professionals, and abortion rights advocates petitioned the U.S. Food and Drug Administration (FDA) on Tuesday to urge Danco Laboratories to seek approval of mifepristone, a pill used in terminating early pregnancies at home, for miscarriage management.

Danco, one of two U.S. companies that make the medicine, said that right now it has no plans to do so.

«At this time, we are not planning to submit (an application) for miscarriage management, but may reconsider in the future,» a spokesperson said. Danco is currently working with the FDA on changes to where patients can get the drug.

The American College of Obstetricians and Gynecologists (ACOG) asked the FDA to invite Danco to submit a Supplemental New Drug Application (sNDA) for miscarriage management.

«It is a safe and essential part of the most effective regimen for miscarriage management,» ACOG said.

An FDA spokesperson said the agency was reviewing the petition and would respond directly to the petitioner.

Mifepristone, in combination with a second drug called misoprostol that has various uses including miscarriage management, induces an abortion up to 10 weeks into a pregnancy. It is only available through a certified doctor’s prescription.

The combination is more effective for treating an early miscarriage than misoprostol alone, ACOG said in its petition, which was signed by 48 other groups including the American Medical Association and the American Civil Liberties Union.

Abortion bans have gone into effect in more than a dozen states since the U.S. Supreme Court overturned the constitutional right to terminating pregnancies when it scrapped its landmark 1973 Roe v. Wade ruling on June 24.

Some bans target mifepristone, which limits access to the drug for the purposes of managing a miscarriage because it is only approved to terminate a pregnancy.


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