Dr. Christina Francis, an OB-GYN from Fort Wayne, Indiana, and chair of the board of the American Association of Pro-Life Obstetricians and Gynecologists, speaks in front of the 5th Circuit courthouse in New Orleans on May 17, 2023, following arguments on a case challenging FDA approval of the abortion pill. Greg LaRose/Louisiana Illuminator
NEW ORLEANS — A federal appeals court panel quizzed lawyers during oral arguments Wednesday over a Texas judge’s decision that could end access to the abortion pill nationwide.
Observers see the 5th Circuit Court of Appeals as a legal way station for the case, in which anti-abortion groups sued the U.S. Food and Drug Administration, arguing its approval of mifepristone in 2000 was improper and subsequent changes to its use didn’t rely on solid science.
The three-judge panel’s ruling, which could come anytime after oral arguments, will likely be put on hold as the case moves up to the U.S. Supreme Court.
In the meantime, access to mifepristone, one of two drugs used in medication abortions, remains legal under a temporary order from the U.S. Supreme Court.
U.S. Deputy Assistant Attorney General Sarah Harrington called U.S. District Court for the Northern District of Texas Judge Matthew Kacsmaryk’s ruling to overturn mifepristone’s approval an “unjustified attack on FDA scientific expertise.”
Physicians who brought the lawsuit failed to demonstrate “imminent risk” of being forced to perform a medical procedure that goes against their conscience as a result of complications from mifepristone, Harrington said.
Physicians aren’t required to perform procedures to which they hold a religious or moral objection, under the federal Emergency Medical Treatment and Labor Act, Harrington said.
Jessica Ellsworth, the lawyer representing Danco Laboratories, which manufactures the name brand version of mifepristone known as Mifeprex, questioned the claims of the anti-abortion physicians who brought the suit and were referenced in court records.
“The declarants offer nonspecific statements that are untethered to actual facts about what drug a patient took,” Ellsworth said. “They often say, ‘The patients can’t tell me what they took,’ so we don’t know even that it was FDA-approved mifepristone.”
One example Ellsworth cited involved a patient who took an unidentified abortion drug from India, which wasn’t FDA-approved, and another instance where a pregnant woman took mifepristone while on blood thinners, after being told she wasn’t eligible for medication abortion. Neither case supports the anti-abortion groups’ contention that mifepristone is an untested, riskier medication, she said.
Alliance Defending Freedom Senior Counsel Erin Morrow Hawley argued the appeal for the anti-abortion legal organization that filed the lawsuit on behalf of four medical organizations and four doctors.
Hawley rejected the notion that mifepristone should be left on the market to aid in miscarriage care, saying that not all doctors prescribe it to treat pregnancy loss and that an “off-label” use shouldn’t be used to uphold the approval.
“I don’t think that that would be an appropriate basis or an appropriate consideration to uphold FDA approval here,” Hawley said.
Questions for Danco lawyer
The three-judge appeals panel included Jennifer Walker Elrod, who was appointed by former President George W. Bush, as well as James C. Ho and Cory T. Wilson, who were both appointed by former President Donald Trump.
The panel had pointed questions for the appellants’ counsel on whether the FDA’s role in health policy extended past review and approval of medication. Elrod specifically took exception with language in Danco’s briefs, calling it a personal attack on Kacsmaryk, the Texas judge.
“This is much more the kind of remarks towards district court that we normally don’t see from learned counsel,” Elrod told Ellsworth, “and I’m wondering if you would have had more time and not been under a rush and probably exhausted from this whole process, would those have been statements that would have been included in your brief?”
“I don’t think that those remarks, any of them, were intended as any sort of personal attack,” Ellsworth responded. “They were an attack on the analysis and reasoning.”
The judges asked the appellants what repercussions FDA approval — and its possible reversal — might have on telemedicine. In 2021, the agency removed the requirement for an in-person doctor’s visit to prescribe mifepristone and misoprostol, the second prescription used in medication abortion.
Elrod questioned how physicians could accurately confirm how far along a pregnancy is without an in-person exam. Harrington said doctors can ask specific questions that inform their decisions on prescribing the abortion drug.
Answering a similar question, Ellsworth told the judges the FDA doesn’t regulate the practice of medicine, to which Elrod responded the agency does have a stake in the negative outcomes of the medication it approves.
Questions from the judges for Hawley largely involved the FDA’s approval and updates for mifepristone use.
“The FDA acknowledges that emergency room doctors are going to be part of the solution in cleaning up the messes left for women suffering consequences of chemical abortion,” Hawley said, referencing the agency’s original approval of mifepristone.
She also cited figures from an FDA medication guide published in January that say between 2.9% and 4.6% of women who take mifepristone “will present to the emergency room,” although Hawley acknowledged after a probe from Elrod that not all instances involve an actual emergency.
Lawsuit challenged FDA approval
Alliance Defending Freedom filed the lawsuit in November, arguing the FDA erred in how it approved mifepristone in 2000 while also contending that it’s not safe and effective.
The lawsuit called on the federal district court to overturn the 2000 approval, but said that if the judge didn’t do that, he should revert prescribing and use pre-2016 instructions.
Changes that year increased when mifepristone could be used from seven to 10 weeks gestation, reduced the number of in-person visits from three to one and changed the dosage and timing of the two-drug regimen.
The FDA broadened who could prescribe the medications from only doctors to health care providers with the ability to prescribe pharmaceuticals.
In 2021, the FDA removed the in-person dispensing requirement allowing qualified health care providers to prescribe mifepristone and the second drug, misoprostol, via telehealth and send the medication through the mail.
Kacsmaryk agreed with the claims the anti-abortion organizations made, releasing an opinion in early April revoking the FDA’s 2000 approval of mifepristone.
Mifepristone remains available under a ruling the U.S. Supreme Court issued April 21 that blocked enforcement of that ruling.
That likely means whatever action the 5th Circuit Court of Appeals takes following Wednesday’s oral arguments would be paused until the nine justices on the Supreme Court decide whether to hear the case.
If the Supreme Court does take the case and issues a ruling on the approval and use of mifepristone it would apply to every state in the country, including those that have protected abortion access up to 10 weeks, the cap on the medication’s use.
Drugmakers file brief
Pharmaceutical companies have raised concerns about the ability of a judge to alter the use and administration of an FDA-approved medication, or overturn that decision altogether.
The Pharmaceutical Research and Manufacturers of America, or PhRMA, and others filed a 40-page brief with the appeals court arguing against overturning or altering the FDA’s judgment.
They argued the federal district judge “erred by replacing FDA’s scientific judgments with its own views on what information should be considered and how it should be assessed.”
They also wrote the ruling “risks stifling pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations.”
And major medical organizations, including the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine and the American Society for Reproductive Medicine, have urged the court to keep mifepristone legal.
They contend the district court’s ruling “disregards decades of unambiguous analysis supporting the use of mifepristone in miscarriage and abortion care.”
“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,” a group of 13 medical organization wrote in a brief to the appeals court.
U.S. House gets involved
Not everyone, however, agrees with leaving the medical and scientific approval process to the FDA.
U.S. House Republicans sought to change access to medication abortion Wednesday, introducing a funding bill that would nullify changes the FDA made in January.
Those changes allowed brick-and-mortar and mail-order pharmacies to apply to dispense mifepristone to patients after they received a prescription. The FDA also solidified changes made during the pandemic that ended the in-person dispensing requirement.
A summary of the agriculture appropriations bill from House Republicans says the measure includes a “provision that ends mail-order chemical abortion drugs.”
The legislation, one of the dozen annual appropriations bills, funds the Agriculture Department and the FDA as well as the Commodity Futures Trading Commission and the Farm Credit Administration.
Maryland Republican Rep. Andy Harris chairs the subcommittee tasked with drafting the legislation.
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