The FDA approved mifepristone under the brand-name Mifeprex in 2000, and an abortion-drug regimen that has seen few deaths and a low rate of adverse events in more than two decades of use. (Peter Dazeley/GettyImages)
WASHINGTON — The lawsuit over access to the abortion pill goes before the 5th Circuit Court of Appeals in New Orleans on Wednesday, the next step on a path that will likely end at the U.S. Supreme Court.
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.
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More than a dozen medical organizations — including the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine and the American Society for Reproductive Medicine — argued in support of access to mifepristone in a brief to the appeals court.
The 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 wrote in their 48-page brief that the Texas district judge’s ruling “is rife with medically inappropriate assumptions and terminology.”
“It disregards decades of unambiguous analysis supporting the use of mifepristone in miscarriage and abortion care,” the 13 medical organizations wrote. “It relies on pseudoscience and on speculation, and adopts wholesale and without appropriate judicial inquiry the assertions of a small group of declarants who are ideologically opposed to abortion care and at odds with the overwhelming majority of the medical community and the FDA.”
The appeals panel deciding the case will include Judges Jennifer Walker Elrod, James C. Ho and Cory T. Wilson.
Elrod was nominated by former President George W. Bush in 2007 and confirmed by the Senate on a voice vote. Ho and Wilson were nominated by former President Donald Trump and were confirmed by the Senate on mostly party-line votes.
The case, Alliance Hippocratic Medicine v. FDA, began in November when anti-abortion groups filed a suit challenging the U.S. Food and Drug Administration’s approval of mifepristone in 2000.
The anti-abortion organizations called on a federal judge to overturn the approval, removing mifepristone from the market, though they also challenged changes to how the medication is prescribed and used following changes at the federal level in 2016 and 2021.
Alliance Defending Freedom, the anti-abortion legal organization that filed the lawsuit, wrote in its brief to the 5th Circuit Court of Appeals that the FDA erred when it approved mifepristone.
ADF attorneys claim that mifepristone is not safe and effective for pregnancy termination, rejecting the scientific studies cited by medical organizations that show otherwise.
ADF’s legal team also opposes changes the FDA made to mifepristone’s use and administration in 2016, including that the medication could be used up to 10 weeks into a pregnancy, an increase from seven weeks.
The 2016 changes reduced the number of in-person visits from three to one, allowed qualified health care providers to prescribe the medication and changed some dosage and timing instructions. Non-fatal adverse incidents no longer had to be reported to the FDA, under the changes.
Then, in 2021, the FDA began allowing mifepristone to be prescribed via telehealth and sent to patients through the mail. The alterations were similarly opposed by ADF in the court filing.
The anti-abortion organizations call on the 5th Circuit Court of Appeals to uphold the Texas district judge’s decision that stayed the FDA’s approval.
“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 wrote in a 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.”
The 5th Circuit Court of Appeals is scheduled to hear arguments in the appeal on Wednesday at 1 p.m. Central. An audio live stream is scheduled to be found here when the hearing begins.
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