Court Maintains Access to Abortion Pill, but With Restrictions

OB/Gyn
>
Abortion

— Judges temporarily block drug from being mailed, restore in-person visit requirement

by
Shannon Firth, Washington Correspondent, MedPage Today
April 13, 2023

Mifepristone (Mifeprex) can remain on the market, a federal appeals court ruled late on Wednesday, but with temporary restrictions that align with the drug’s original 2000 approval until the full case can be heard.

Prescriptions for mifepristone will again require an in-person visit with a physician, use will be limited to individuals no more than 7 weeks pregnant, and the drug can no longer be distributed by mail.

The appeals court decision partially overruled Friday’s decision from Matthew Kacsmaryk, a federal judge of the Northern District of Texas, who had ordered that mifepristone’s approval be overturned completely.

In Wednesday’s decision, the three-judge panel of the Fifth Circuit Court of Appeals in New Orleans said the statute of limitations bars the plaintiffs — Alliance for Hippocratic Medicine and other anti-abortion physicians — from challenging the FDA’s 2000 approval. Yet they ruled it was not too late for the group to challenge the FDA’s 2016 risk evaluation and mitigation strategies (REMS) program.

Under the REMS program, the FDA began a series of changes that increased access to mifepristone, including extending its indication until up to 10 weeks gestation in 2016 and making the drug permanently available by mail in 2021.

Following the Texas ruling, the Biden administration and mifepristone’s drugmaker Danco Laboratories requested an emergency stay of the order from the Fifth Circuit Court, in order to extend the time until the decision took effect. The Department of Justice, which is representing the FDA in the case, had stated that the Texas “court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity.”

Part of a two-drug combination with misoprostol, mifepristone is the most commonly used medication for abortion. Experts from the American College of Obstetricians and Gynecologists, said on Monday that misoprostol alone is “safe and effective” for both abortion in the first trimester and miscarriage management, but not as effective as the two-drug regimen.

In the meantime, multiple states have begun stockpiling mifepristone, according to the AP.

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  Shannon Firth has been reporting on health policy as MedPage Today’s Washington correspondent since 2014. She is also a member of the site’s Enterprise & Investigative Reporting team. Follow

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