A federal judge in Louisiana on Tuesday ordered the Food and Drug Administration to provide a status report of its review of the abortion pill mifepristone, which the agency has so far kept under wraps.
U.S. District Judge David Joseph ruled that a case brought by the state of Louisiana against the FDA that seeks to impose restrictions on mifepristone must be paused in the meantime. Joseph wrote that the agency has to finish its safety review “within a reasonable timeframe.”
Robert F. Kennedy Jr., the secretary of the Department of Health and Human Services, announced in a September letter that the FDA would conduct a safety review of abortion pills, which account for more than half of all abortions in the U.S.
Since then, health officials have kept the details of the review secret. In February, FDA Commissioner Marty Makary reportedly failed to give Republican senators a timeline for when the review would be completed. The lack of action on the matter has angered anti-abortion leaders, some of which previously told NOTUS they felt “betrayed” by the Trump administration on the matter.
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Joseph gave the FDA six months to file a report on “the status of its review in terms of process and any updated timeframe for completion of review,” he wrote in his opinion.
“FDA has an obligation to act with all deliberate speed to review its past actions and complete a thorough analysis that addresses the deficiencies it has acknowledged,” Joseph said. “The parties and the American public deserve nothing less.”
The Biden administration first made abortion pills available via telehealth in 2021, during the COVID-19 pandemic. This guidance became permanent in 2023.
The state of Louisiana sued the FDA in October over that guidance, arguing that it violates the Comstock Act. Abortion pills being available via mail “directly violates Louisiana’s abortion laws and prevents Louisiana from protecting the lives of unborn babies,” the state argued in its complaint.
A recent report from the Guttmacher Institute, a research organization that supports abortion rights, found that patients in states where abortion is banned are increasingly able to access abortion pills via telehealth. Mifepristone is considered safe and effective by leading medical organizations.
In his ruling, Joseph suggested that Louisiana was likely to succeed in its challenge to the FDA. He seemed to agree with Louisiana’s argument that there were “recent safety concerns” that bring into question whether the FDA’s decision to make mifepristone broadly available through the mail was legal. However, Joseph concluded that the “FDA’s review should be conducted and completed free from judicial interference.”
If the FDA fails “to complete its review and make any necessary revisitions” to mifepristone, Joseph said the “Court’s analysis … will inevitably change,” suggesting he could order the agency to make abortion pills accessible only in person, which would heavily restrict access to medication abortion.
In a statement to NOTUS after publication, an HHS spokesperson said the FDA “is conducting its safety study of mifepristone, including the collection of robust and timely data, evaluation of data integrity, and implementation of the analyses, validation, and peer-review.”
“Once the FDA finishes its analysis of the data, the agency will decide whether to make substantive changes” to how abortion pills are accessed, the spokesperson continued. “The agency is taking care to do this study properly and in the right way.”
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Editor’s Note: This story has been updated with comment from HHS.
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