The manufacturer of the abortion pill mifepristone asked the Supreme Court to pause Friday’s decision by a federal appeals court that blocked mailing of the medication.
The request Saturday by Danco Laboratories LLC comes after the US Court of Appeals for the Fifth Circuit granted Louisiana’s request to temporarily halt Food and Drug Administration decisions that allowed mifepristone to be mailed into the state despite its abortion ban.
Friday’s order effectively blocks the FDA’s 2023 Risk Evaluation and Mitigation Strategy (REMS), which removed a requirement that mifepristone be dispensed in-person.
Danco on Friday asked the Fifth Circuit for an emergency administrative stay of the decision for one week while it took its appeal to the Supreme Court. On Saturday, Danco filed their request to the high court.
“It bears emphasis how unprecedented the Fifth Circuit’s order is,” Danco said Saturday . “Never before has a federal court purported to immediately enjoin a several years’ old drug approval; restrict a distribution system for that drug that manufacturers, providers, patients, and pharmacies have all been using for years; or reinstate conditions that FDA determined do not meet the mandatory statutory criteria.”
The Fifth Circuit’s decision marks a victory for pro-life advocates and states, which largely viewed abortion pills as a means to circumvent state restrictions and have claimed that the medication was used by men to force women into having abortions. But the litigation comes at a complex time for the Trump administration.
The FDA’s decision “injures Louisiana by undermining its laws protecting unborn human life and also by causing it to spend Medicaid funds on emergency care for women harmed by mifepristone,” Fifth Circuit Judge Stuart Kyle Duncan wrote Friday. “Every abortion facilitated by FDA’s action cancels Louisiana’s ban on medical abortions” while undermining state policy.
Health and Human Services Secretary Robert F. Kennedy Jr. said last year that the federal government must revisit safety decisions on mifepristone, but in December Bloomberg News reported the FDA was slow-walking the effort until after the midterm elections. HHS denied the claim.
Louisiana sued the FDA in October over its decision to allow the drug to be dispensed without an in-person visit to a medical provider, arguing it made it difficult to enforce state restrictions. The lower court paused the lawsuit on April 7 at the Trump administration’s request, though pressed the federal government to deliver on the safety study, prompting the state’s appeal.
Question of Safety
Reproductive rights groups say mifepristone is proven to be safe, and limited research stating otherwise has been discredited. A Guttmacher Institute study found that in 2023, medication-based abortion accounted for over 60% of abortions in the US.
“Telehealth has been the last bridge to care for many seeking abortion, which is precisely why Louisiana officials want it banned,” Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement. “This isn’t about science—it’s about making abortion as difficult, expensive, and unreachable as possible.”
Louisiana Attorney General Liz Murrill said in a statement that the Fifth Circuit’s decision was about access to the drug, praising the order as the end of a “nightmare” caused by the Biden administration’s policy resulting in “the deaths of thousands of Louisiana babies” via “illegal mail-order abortion pills.”
The US Department of Health and Human Services, under which the FDA operates, didn’t immediately respond to a request for comment.
Generic mifepristone manufacturer GenBioPro, intervened in the case along with Danco out of concerns that the Trump administration was not interested in defending FDA policy.
Evan Masingill, the company’s CEO, said in a statement Friday that he was “alarmed by this court’s decision to ignore the FDA’s rigorous science and decades of safe use of mifepristone in a case pursued by extremist abortion opponents.” He accused “anti-abortion special interests” of undermining patients’ access to care, while reinforcing the company’s commitment to making mifepristone readily available.
Revisiting the Issue
Louisiana’s case isn’t the first time abortion pill access has come before the Fifth Circuit.
In August 2023, the appeals court ruled against FDA decisions on the drug, including one allowing it to be mailed. That battle went all the way to the Supreme Court. The justices upheld abortion pill access, though they did so on standing, leaving the door open for future challenges.
Christian legal group Alliance Defending Freedom was involved in that litigation as well as Louisiana’s lawsuit, representing a fellow plaintiff of the state.
ADF counsel Erin Hawley said after Friday’s order that “the Biden FDA’s unlawful authorization of mail-order abortion drugs was meant to nullify state laws that protect life.”
“This was a reckless political action that destroys unborn life, puts women’s safety in serious jeopardy, and completely subverts state law,” Hawley said.
The case is Louisiana v. FDA, 5th Cir., No. 26-30203, Opinion filed 5/1/26
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