Pro-life medical groups on Tuesday urged the Supreme Court to reject the Justice Department’s emergency application to remove temporary court-imposed limits on the abortion pill, saying the order restores “crucial safeguards” without banning access to pregnancy-termination drugs.
Attorneys for the Alliance Defending Freedom accused the Biden administration and Danco Laboratories, which manufactures mifepristone, of overreacting to the U.S.Court of Appeals for the 5th Circuit’s decision that temporarily reinstates the FDA’s pre-2016 rules on the two-pill abortion regimen.
“Under the Fifth Circuit’s reasonable order, women will still have access to chemical abortion drugs under the same restrictions that existed for the first 16 years of mifepristone’s use,” the attorneys said in a court brief. “The only effect of the lower court’s order is to restore a modicum of safety for the women and girls who use the drug, including supervision and oversight by a physician.”
The Supreme Court is expected to rule this week on the Justice Department’s application for emergency relief to vacate or stay the 5th Circuit’s ruling pending the outcome of a lawsuit challenging the agency’s 2000 approval of mifepristone for pregnancy termination.
The ruling means that the abortion drugs may be used up to seven weeks instead of 10 weeks, requires three in-person doctor visits instead of none, requires licensed physicians to prescribe the drugs and prevents the pills from being delivered by mail.
The Food and Drug Administration approved the abortion pills in 2000, then began with its 2016 overhaul to roll back restrictions on their use. Earlier this year, the agency made permanent its 2021 pandemic-era changes allowing the pills to be dispensed via telehealth through the mail.
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The Justice Department argued that the orders by the appeals court and U.S. District Judge Matthew Kacsmaryk create “regulatory chaos” and undermine medical science by substituting their own judgment for that of the FDA.
In their response, the pro-life medical associations and physicians contend that the agency “brazenly flouted the law and applicable regulations.”
“Not a single study that FDA relied on for the 2016 Major Changes, for instance, examined what would happen if FDA removed every safeguard,” said the ADF filing. “This is akin to an agency finding a car safe based on studies with seat belts without airbags, then concluding the car was safe without either seatbelts or airbags.”
The FDA has argued that the abortion-pill regimen has been used safely for 23 years, recently becoming the most common form of U.S. pregnancy termination, with major medical associations comparing its safety record to that of Advil.
In 2016, however, the agency lifted the requirement that medical providers report non-fatal adverse effects from the drugs, making it more difficult to assess their impact.
“Their main claim is a sky-is-falling argument that compares chemical abortion to drugs like ibuprofen,” said the ADF brief. “But mifepristone’s ‘Black Box’ warnings and Danco’s own Patient Agreement Form describe serious possible adverse effects—including death— that place it on a vastly different level than ibuprofen.”
The elimination of required in-person doctor visits also makes it virtually impossible to check for an ectopic pregnancy or verify the gestational age, putting at risk women who take the pills after 10 weeks’ pregnancy, said the response.
“Plaintiffs and their patients will be harmed without the reinstatement of these safety guardrails—guardrails that allow abortion providers to rule out ectopic pregnancies, verify gestational age, and identify any contraindications prior to prescribing mifepristone,” said the filing. “These guardrails also allow providers to identify potential complications like a failed chemical abortion, sepsis, and hemorrhage.”
They argued the cost is being borne by doctors grappling with an uptick in ER visits. Pro-life physicians say they have rushed to save women from bleeding out, in some cases performing emergency surgical abortions on still-living fetuses in violation of their conscience rights.
The 5th Circuit is expected to hold expedited oral argument on its stay depending on the outcome of the Justice Department’s Supreme Court application.
• Alex Swoyer contributed to this report.
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