A federal appeals court late Wednesday partially blocked a Texas judge's decision halting the FDA's approval of the widely used abortion pill mifepristone.
The big picture: The 2-1 ruling by a three-judge panel on the conservative-leaning court means that, for now, mifepristone is still available in the U.S., but with several strict limitations.
Details: The New Orleans-based 5th U.S. Circuit Court of Appeals granted the Biden administration's request to put on hold part of the Texas judge's order blocking the Food and Drug Administration's approval of the pill, pending the outcome of a lawsuit challenging the FDA on this authority, which has been in place since 2000.
- However, changes the FDA made in 2016 and later that lifted certain restrictions on mifepristone are now suspended under the appeals court ruling. That restores a requirement that patients need the supervision of a qualified physician to obtain the pill.
- The judges also suspended the FDA's 2021 approval for the pills to be sent by mail, as well as its approval of a generic version.
- The court also reduced the period at which a person can take the drugs, from 10 weeks of pregnancy to seven weeks.
Zoom in: While the appellate court sided with the Biden administration's argument that it is too late for the plaintiffs to challenge the FDA's initial 2000 approval of the drug, it argued that the authorization overall could be be overturned.
- The court said that the plaintiffs "reasonably argue that FDA's 2021 'full review'" of mifepristone's approval "was in effect a reconsideration of FDA's 2000 Approval."
- "Indeed, plaintiffs might very well prevail on that claim later in this litigation," the judges wrote.
- The court admitted that they could not yet rule on that argument "at this early juncture," considering they're only deciding on whether initial Texas ruling stands, not the merits of the case as a whole.
What they're saying: "Federal agencies that act lawlessly must be held accountable," said Erin Hawley, senior counsel for Alliance Defending Freedom, which is representing the plaintiffs in the case.
- The FDA "has evaded its legal responsibility to answer the American people’s questions for two decades," she added, calling the appellate court's decision "a significant victory."
Catch up quick: U.S. District Court Judge Matthew Kacsmaryk last week stayed the FDA's approval of mifepristone, in a widely criticized decision that used anti-abortion rhetoric to argue that medication abortion has a "negative impact" and that the agency's safety data on the pill is "potentially misleading."
- The Justice Department quickly appealed, calling Kacsmaryk's order "extraordinary and unprecedented."
- The Texas judge, the DOJ argued, "upended decades of reliance by blocking the FDA's approval of mifepristone ... based on the court's own misguided assessment of the drug's safety."
- Mifepristone is part of a two-drug regimen used in medication abortion, which now accounts for 53% of abortions in the U.S., according to the Guttmacher Institute, a research organization that supports abortion rights.
Of note: The appellate court's opinion also uses anti-abortion rhetoric instead of commonly accepted abortion-related terms used by health experts.
- At one point, the judges refer to a fetus as an "unborn child" and use the term "chemical abortion."
What's next: The Biden administration and the drug's manufacturer is expected to appeal to the Supreme Court to have the lower court's ruling fully overturned.
- Additionally, the anti-abortion plaintiffs could potentially appeal to the Supreme Court to have mifepristone's 2000 approval revoked.
Between the lines: There's still a conflicting ruling issued by a federal court in Washington state that looks to prohibit the FDA from suspending its approval of mifepristone.
- That court is expected to issue clarification today as to how the Biden administration should obey their order while having to also follow the appeals court's decision.
- Legal experts say that it's possible the federal government will appeal the Washington decision to the U.S. 9th Circuit Court of Appeals, and potentially having two appellate orders ruling over the FDA's authorization. That would make it almost inevitable that the Supreme Court will need to intervene.
Read the ruling:
