A Fifth Circuit Court of Appeals panel handed down a decision Wednesday batting down challenges to the Food and Drug Administration’s (FDA) initial approval of abortion drug mifepristone, but reinstituting restrictions that the agency has lifted in recent years.
The three-judge panel reversed the most headline-grabbing part of Donald Trump-appointed district court Judge Matthew Kacsmaryk’s decision, in which he ruled that the FDA’s 20-plus-year approval of mifepristone should be nixed.
The anti-abortion groups who brought the suit had argued that alterations to the drug’s disbursement regime in 2016 qualified as “reopening” the question of that initial approval, giving courts the opportunity to revisit it. The Fifth Circuit panel rejected that claim.
“They do not alter FDA’s basic assumption that mifepristone is safe and effective, subject to certain conditions for use,” the panel wrote of the 2016 changes.
The panel held the same on the 2021 alterations to the drug’s regime, where the FDA, most significantly, removed the in-person dispensing requirement.
“As with the 2016 Amendments, removing the in-person dispensing requirement does not change the basic concept of allowing women to use mifepristone,” the judges wrote.
But, the judges were very willing to question the FDA’s decision-making, including on fairly technical clinical aspects. For example, the judges gave the greenlight to reimposing restrictions that the FDA lifted in 2016 — including expanding the on-label gestational window in which the drug can be used — because they quibbled with how the agency determined that the changes were safe.
The ruling is also replete with histrionic messaging about the danger of mifepristone, talking points that have been a ubiquitous and long-lived tactic of the anti-abortion movement and have resulted in restrictions that major medical groups have long critiqued as based in politics and not medical necessity.
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The Supreme Court had previously issued a stay in the case, meaning that mifepristone will remain fully accessible until the high Court either issues its own ruling or declines to hear the likely coming appeal from the Fifth Circuit.
See here for the previous entry. I’m a bit pressed for time, so read the rest of the story, which contains some prime Fifth Circuit winguttery about abortion, and the ruling, which is embedded. Given the stay, nothing has changed from a practical perspective, and I don’t think much has changed in terms of what SCOTUS will ultimately be asked to do. Either they’re willing to YOLO their way towards more abortion restrictions while also making all of Big Pharma nervous, or they’ll pull it all or mostly all back, on whatever pretext they find suitable. We’re just going to have to wait and see. Mother Jones, The 19th, and the Trib have more.