US Supreme Court: Mifepristone abortion drug remains legal with no new restrictions
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Key takeaways:
- The Supreme Court said the plaintiffs lacked standing to challenge the FDA’s approval of mifepristone.
- Mifepristone use remains legal without new restrictions.
On Thursday, the U.S. Supreme Court ruled 9-0 that access to mifepristone for medication abortion remains legal including rules adopted since 2016 loosening original dispensing requirements and gestation limits.
The justices determined that the plaintiffs in Food and Drug Administration et al v. Alliance for Hippocratic Medicine et al lacked standing to bring the case. Citing complications associated with its use, the plaintiffs sought to have the FDA approval of mifepristone granted in 2000 overturned entirely or regulations for its use adopted in 2016 and 2021 reversed.
The decision was what Molly Meegan, JD, chief legal officer for ACOG, said she expected when she spoke during a press briefing in May. Limiting FDA approval “would really destabilize the whole drug and pharmaceutical industry and the drug approval industry,” she said.
“The American Medical Association applauds today’s unanimous ruling by the U.S. Supreme Court that preserves access to mifepristone for millions of women across the country,” a press release from the AMA stated. “Efforts to second guess the FDA’s scientific judgment and roll back access to mifepristone were based on a sham case that not only lacked standing, but relied on speculative allegations and ideological assertions to undermine decades of rigorous scientific review proving the drug is highly safe and effective for both termination of pregnancy and for medical management of miscarriage.”
ACOG stated the organization was relieved by the decision.
“Today’s decision from the U.S. Supreme Court provides us with long-awaited relief. We now know that patients and clinicians across the country will continue to have access to mifepristone for medication abortion and miscarriage management,” the ACOG press release stated. “Decades of clinical research have proven mifepristone to be safe and effective, and its strong track record of millions of patient uses confirms that data.”
The ruling ends this case, but more challenges to abortion through availability of mifepristone are likely, according to Meegan.
“It’s been very interesting to watch [Justice Samuel] Alito and [Justice Clarence] Thomas talk about the [1873] Comstock Act [banning the mailing of abortifacients] in the mifepristone case when the court [appeal] was not granted on that point,” Meegan told Healio in May. “It’s almost like they’re sending a message like, please bring this case and we are going to do our best to give you what you want, if you can come to us with a different argument.”
References:
- ACOG relieved by Supreme Court decision allowing continued access to mifepristone, calls for removal of REMS. https://www.acog.org/news/news-releases/2024/06/acog-relieved-by-supreme-court-decision-allowing-continued-access-to-mifepristone-calls-for-removal-of-rems. Published June 13, 2024. Accessed June 14, 2024.
- AMA applauds Supreme Court ruling preserving access to mifepristone. https://www.ama-assn.org/press-center/press-releases/ama-applauds-supreme-court-ruling-preserving-access-mifepristone. Published June 13, 2024. Accessed June 14, 2024.