The 5th U.S. Circuit Court of Appeals in New Orleans partially granted the DOJ’s request to hold a ruling that revoked the FDA’s approval of the abortion pill Mifepristone:
At this preliminary stage, and based on our necessarily abbreviated review, it appears that the statute of limitations bars plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000. In the district court, however, plaintiffs brought a series of alternative arguments regarding FDA’s actions in 2016 and subsequent years. And the district court emphasized that its order separately applied to prohibit FDA’s actions in and after 2016 in accordance with plaintiffs’ alternative arguments. As to those alternative arguments, plaintiffs’ claims are timely. Defendants have not shown that plaintiffs are unlikely to succeed on the merits of their timely challenges. For that reason, and as more fully explained below, defendants’ motions for a stay pending appeal are DENIED IN PART. Defendants’ alternative motions for an administrative stay are DENIED AS MOOT. Plaintiffs’ motion to dismiss the appeal is DENIED. The appeal is EXPEDITED to the next available Oral Argument Calendar.
U.S. District Judge Matthew Kacsmaryk, in Amarillo, TX, made the original ruling last week.
But the three-judge panel said a separate part of Kacsmaryk’s decision, which suspends changes the FDA made to the drug’s approved use in 2016, could go into effect. The panel also determined that the agency’s finding in 2021 that mifepristone can be distributed by mail would be paused, as well, as Kacsmaryk ordered.The court’s decision imperils widespread availability of the drug, as it would require patients to make in-person visits to obtain it.The 2016 changes, among other things, reduced the number of in-person visits that patients are required to make from three to one and allowed the pills to be prescribed to women at up to 10 weeks’ gestation instead of up to seven weeks.The appeals court said it would expedite its full consideration of the case.
The Court detailed women’s testimonies and experiences when taking Mifepristone and doctors treating the women. The plaintiff doctors said they would likely see more patients because of the drug. The Court wrote:
That’s because FDA has removed almost all of mifepristone’s REMS [risk evaluation and mitigation strategies] and thus enabled women to (1) get the drug without ever talking to a physician, (2) take the drug without ever having a physical exam to ensure gestational age and/or an ectopic pregnancy, and (3) attempt to complete the chemical abortion regimen at home; FDA has also (4) directed the hundreds of thousands of women who have complications to seek “emergency care” from the plaintiffs and plaintiffs’ hospitals. Several doctors testified that they have seen an increasing number of women coming to the emergency room with complications from chemical abortions due to FDA’s virtual elimination of controls on the dispensing and administration of the drugs.
The Court explained it took its stance because:
Rather, we hold that on the record before us applicants know that hundreds of thousands of women will—with applicants’ own statistical certainty—need emergency care on account of applicants’ actions. And because applicants chose to cut out doctors from the prescription and administration of mifepristone, plaintiff doctors and their associations will necessarily be injured by the consequences. This is an exceedingly unusual regime. In fact, as far as the record before us reveals, FDA has not structured the distribution of any comparable drug in this way.
The Court also seemed baffled as to why the FDA described mifepristone as “comparable to ibuprofen” since FDA documents “show that mifepristone bears no resemblance to ibuprofen.”
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