Supreme Court maintains telemedicine access to abortion pill mifepristone pending appeal – JURIST Clio

Supreme Court maintains telemedicine access to abortion pill mifepristone pending appeal – JURIST

 Clio

The US Supreme Court on Thursday allowed The abortion drug mifepristone will continue to be available nationwide by mail and via telemedicine. That leaves in place a Fifth Circuit order that reinstated an in-person dispensing requirement while Louisiana’s challenge to the drug’s regulation is heard in the lower courts.

The letter, without a signature command In Danco Laboratories, LLC v. Louisiana and the consolidated case GenBioPro, Inc. v. Louisiana provided no justification. The stay remains in effect by order of the Fifth Circuit underlying calling and any subsequent application for a certificate. If the court refuses to review, the stay ends automatically.

Justices Clarence Thomas and Samuel Alito contradictedeveryone writes separately. Alito, who serves as district judge for the Fifth Circuit, granted previous administrative stays on May 4 May 11th This preserved access to mifepristone while the full court considered the manufacturers’ applications.

Alito opened his dissent by calling “the Court’s baseless order granting stays in this case … remarkable” and framing the underlying litigation as “executing a plan to undermine” the Court’s 2022 decision Dobbs vs. Jackson Women’s Health Organizationwhich returned abortion regulation to the states. He wrote that enforcement of Louisiana’s near-total abortion ban has been “thwarted” by out-of-state providers, advocacy groups and states that have passed so-called protective laws that insulate abortion providers from other states’ civil and criminal procedures.

Quote Louisiana’s RecordsAlito wrote that “nearly 1,000 abortions” occur in the state each month — more, he said, than before Dobbs. He referred to New York Governor Kathy Hochul Rejection as an example of cross-border tensions, the extradition of a doctor accused of shipping abortion drugs to Louisiana.

As to the merits of the stay, Alito argued that Danco and GenBioPro had not established the proof of irreparable injury required by Supreme Court precedent. He noted that the companies only devoted three pages of their 80-page applications to the issue and that the U.S. Food and Drug Administration (FDA) is not currently enforcing the in-person dispensing requirement anyway, having committed to an ongoing internal safety review of the 2023 Risk Assessment and Mitigation Strategy (REMS) for mifepristone. Lost sales in states where use of the drug would be unlawful cannot constitute irreparable harm, Alito wrote, citing the principle that “justice requires that profits from unlawful activities be forsaken rather than protected.”

Thomas wrote separately and more briefly to argue that the Comstock Act, an 1873 anti-obscenity law, criminalized the shipment of mifepristone for use in abortions. “Applicants are not entitled to a stay of an adverse court order based on lost profits from their criminal enterprise. They cannot, in any legally relevant sense, suffer irreparable harm from a court order that makes it more difficult for them to commit crimes,” Thomas wrote.

The dispute stems from the FDA’s 2023 amendment to the mifepristone REMS, which eliminated a long-standing requirement that the drug be dispensed during an in-person doctor’s visit and enabled telemedicine prescribing, mail delivery and dispensing through retail pharmacies. Louisiana, which bans almost all abortions, sued the FDA in October 2025, arguing that the rule change was arbitrary and capricious Administrative Procedure Act and that the shipment of the drug violated the Comstock Act.

A federal district court concluded in April that Louisiana was likely to succeed on the merits, but declined to join the 2023 REMS and instead stayed the case so the FDA could complete a pending safety review. Louisiana appealed, and on May 1, a three-judge panel of the Fifth Circuit granted the state’s request to suspend the 2023 REMS while the appeal is ongoing, effectively reinstating the in-person filing requirement statewide. Danco Laboratories, maker of the brand-name version of mifepristone, and GenBioPro, the generic drug maker, have filed emergency declarations Residence applications the following day warning of an immediate disruption to ongoing medical care. Both companies subsequently intervened as defendants.

The safety profile of mifepristone is itself the subject of considerable controversy. The FDA, which has repeatedly reviewed the drug since its approval in 2000, Estimates the rate of serious adverse events is about 0.5 percent and mortality is less than 0.001 percent, and major medical organizations including the American College of Obstetricians and Gynecologists characterize It is considered safe and effective in early pregnancy. Anti-abortion groups and several Republican officials claim that the FDA’s easing of restrictions in 2023 was not adequately supported by safety data. U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. and FDA Commissioner Marty Makary started The agency’s pending internal review, citing a report from the anti-abortion think tank Ethics and Public Policy Center, the appreciated an 11 percent rate of serious adverse events in patients using mifepristone. Notably, the EPPC figure was based on research questioned by reproductive health researchers, Misinformation experts and major news outlets.

The case drew significant amicus participation in the eight days between Danco’s motion and Thursday’s order. Twenty-two states led by New York, 259 members of Congress, the American College of Obstetricians and Gynecologists, the Pharmaceutical Research and Manufacturers of America and a coalition of former FDA commissioners asked the court to grant the stay. A coalition of 23 states led by Nebraska, 113 members of Congress led by Sen. Bill Cassidy (R-La.), the Family Research Council and Susan B. Anthony Pro-Life America urged the court to leave the Fifth Circuit’s order intact.

After Thursday’s ruling, reproductive rights advocates and medical providers praised the decision but warned that the fight continues.

Planned Parenthood said on social media: “Today, the U.S. Supreme Court blocked the 5th Circuit’s decision restricting access to mifepristone. While access to mifepristone remains unchanged for now, the threats to abortion access are far from over. Planned Parenthood will continue to fight to provide access to this care.”

Hey Jane, which describes itself as the “leading virtual abortion clinic in the country,” issued a statement on behalf of CEO Kiki Freedman. “We applaud the Supreme Court’s decision today to grant the stay. Courts should not interfere with the FDA’s expert decisions allowing the prescription of mifepristone via telemedicine. Patients should not have to navigate legal chaos and confusion to continue accessing safe, legal medication abortion,” she wrote.

Critics warned that the ruling put women at medical risk and undermined the right of states to set their own abortion policies. Heartbeat International, an anti-abortion organization, said in a statement: “Women deserve better than dangerous abortion drugs sent through the mail without medical supervision or personal support. A state like Louisiana that values ​​life in its laws should be able to protect its smallest residents as well as their mothers. A justice system that fails to do so means we can only be the United States of Abortion. A state or even a nation that cannot protect its next generation is doomed.”

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