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5th Circuit Court of Appeals to hear arguments on abortion pill case on Wednesday

by | May 16, 2023

By Dave Andrusko

By this time tomorrow, we should have a sense what the 5th U.S. Circuit Court of Appeals will do with a decision by a federal judge, which was modified by an appeals panel, that together curbed the FDA’s free wheeling treatment of mifepristone, part of a two-pill regimen used in “medication abortion.”

The two drugs—mifepristone and misoprostol—account for more than half the abortions performed in the United States.

“The three-judge panel will decide whether to keep, overturn, or alter a ruling from U.S. District Court from the Northern District of Texas Judge Matthew Kacsmaryk, who sought to end the prescription medication’s approval in an early April ruling,” Jennifer Shutt reported.

In their 48 page brief, more than a dozen medical organizations wrote that their “ability to effectively care for patients often requires access to mifepristone, which has undergone rigorous testing and review and has been approved for use in the United States for over 20 years.” They add that Judge Kacsmaryk’s ruling “is rife with medically inappropriate assumptions and terminology.”

The Alliance Defending Freedom, which represents the plaintiff, countered “In sum, FDA has eliminated all safeguards that gave abortion providers the opportunity to rule out ectopic pregnancies, verify gestational age, and identify any contraindications to prescribing mifepristone,” ADF added in its 90-page brief. “It also eliminated the follow-up care that once allowed doctors to identify complications like sepsis, hemorrhaging, or remaining baby body parts and pregnancy tissue.” 

Last November, the Alliance for Hippocratic Medicine challenged the FDA’s original approval of the drug which took place in 2000. Put briefly, the plaintiffs—five medical organizations and four doctors—contend that mifepristone is unsafe and that the F.D.A.’s approval process was flawed.

After Judge Kacsmaryk rendered his decision in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, it was immediately appealed to the 5th Circuit which upheld much of Judge Kacsmaryk’s holding.

The 5th Circuit panel decision would remove the changes made in 2016, 2021, and 2023 which loosened the FDA’s original safeguards applied to mifepristone. It leaves in place the original requirements that the drug be used only up to 7 weeks of pregnancy, including three physician visits, removes the ability for the drug to be mailed or dispensed by pharmacies, prevents non-physicians from administering the drug and reinstates the reporting requirements for non-fatal adverse events.

The 5th Circuit panel, however, refused to undo the FDA’s original approval of mifepristone.

Last month, the Supreme Court temporarily blocked his decision as the appeal moves forward. Until the Supreme Court rules on the matter or declines to intervene, access to the abortion pill will remain unchanged.

The hearing is set for 1:00 Central time on Wednesday.

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