A Trump-appointed appeals court judge on the 5th Circuit grilled a lawyer for Danco Laboratories, the abortion pill maker that sells mifepristone under a brand name, on whether pregnancy is an "illness" and whether Mother's Day is "celebrating illness," during oral arguments in a case challenging the drug's approval.
Judge James Ho appeared skeptical of the Food and Drug Administration's (FDA) use of an "accelerated, less rigorous" process to approve mifepristone more than 20 years ago. Pro-life doctors and medical groups are challenging that approval, arguing FDA erroneously classified pregnancy as an illness to give the drug expedited approval. Ho was sympathetic to that argument.
The judge questioned whether abortion pills were eligible for expedited approval by the FDA when that process is limited to serious illnesses.
"Pregnancy is not a serious illness," Ho said. When Danco attorney Jessica Ellsworth argued the FDA acted correctly, Ho asked, "When we celebrated Mother's Day, were we celebrating illness?"
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"No, your honor," Ellsworth replied. However, she argued the question whether pregnancy is an illness is "irrelevant" because the FDA has used the words "illness," "disease" and "condition" interchangeably when creating the rule for expedited approval.
Ho read the rule, noting the term used is "illnesses."
"I agree, your honor, that is the language that is used in the regulation itself," Ellsworth said. "But as I said, in the preamble and in the discussion of the comments that were submitted in conjunction with that rulemaking, there is discussion about it applying to conditions."
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She added that the FDA has used the same rule for other conditions like acne or infertility that are not necessarily a "serious illness."
Ho sat on a three-judge panel that heard arguments from Danco's attorneys and lawyers for the Justice Department, who defended mifepristone's FDA approval in 2000 and its deregulation in recent years. Under President Biden, the FDA made abortion pills more widely available at retail pharmacies, including delivery by mail.
In a case first filed in the Northern District of Texas, the Alliance Defending Freedom, which represents the pro-life plaintiffs, alleges the FDA "chose politics over science" in approving the drug and acted unlawfully by removing safeguards around mifepristone, including permitting the pill to be delivered by mail.
U.S. District Judge Matthew J. Kacsmaryk issued a highly controversial ruling in April that sided with the pro-life groups and halted FDA approval for abortion pills. His order was partially overturned by the 5th U.S. Circuit Court of Appeals, but the appeals court preserved restrictions that made the drug available only to be dispensed up to seven weeks, not 10, and not by mail.
The case wound its way up to the Supreme Court, which ruled last month that full access to mifepristone may continue as the lawsuit is works its way through lower federal courts. That ruling was a victory for the Biden administration and supporters of abortion rights, but the Supreme Court will likely be asked to revisit the case again if the 5th Circuit panel's decision is appealed.
Fox News' Jon Michael Raasch contributed to this report.
