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A federal judge ruled Tuesday to allow the abortion pill mifepristone to continue being distributed by mail nationwide, while warning that the Biden-era policy could face significant legal changes as the Food and Drug Administration (FDA) conducts its safety review.
U.S. District Court Judge David C. Joseph denied Louisiana Attorney General Liz Murrill’s request to halt the 2023 Risk Evaluation and Mitigation Strategy (REMS) that permits the drug to be mailed across state lines. In his ruling, Joseph cited opposition to what he called “government by lawsuit,” arguing that the FDA’s promised safety review, not litigation, should determine the drug’s regulatory future.
“It is the completion of FDA’s promised good faith, evidence-based, and expeditious review of the mifepristone REMS, not ‘government by lawsuit,’ that this Court finds to be in the public interest,” Joseph wrote.
Despite denying the injunction, Joseph acknowledged Louisiana has legal standing in the case and is likely suffering “ongoing harm” following the 2022 Dobbs decision that allowed the state to ban abortion. The judge granted a stay in the case and ordered the FDA to complete its safety review and report back within six months.
The judge pointedly warned that the court’s position could change if the FDA fails to meet this timeline. “Should the agency fail to complete its review and make any necessary revisions to the REMS within a reasonable timeframe, the Court’s analysis – and the weight accorded to these factors – will inevitably change,” Joseph noted.
Murrill announced plans to appeal the ruling to the Fifth Circuit Court of Appeals, undeterred by the ongoing FDA review. “Judge Joseph concluded that Louisiana has standing to sue and is likely to succeed in showing that the 2023 REMS is unlawful,” she said in a statement. “He also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect.”
The case centers on the FDA’s January 2023 policy that expanded access to mifepristone by allowing certified pharmacies to dispense the medication by mail. This marked a significant shift from earlier restrictions that required in-person dispensing.
Mifepristone was first approved by the FDA in 2000 under strict guidelines, limiting its use to pregnancies at seven weeks’ gestation or fewer and requiring in-person administration by a prescribing physician. These guidelines were initially relaxed in 2016, extending the gestational age limit to 10 weeks and reducing the number of required in-person visits.
During the COVID-19 pandemic, emergency provisions allowed mifepristone to be prescribed and delivered via mail. The FDA permanently codified these changes in its 2023 REMS, which is now under legal challenge in multiple states.
In his ruling, Joseph suggested the 2023 REMS may have been approved without adequate consideration, “at least in part, as part of an effort to circumvent anti-abortion states’ ability to regulate abortion.” He noted evidence indicating “the consequences of this action were predictable – out-of-state providers and related entities would expand access to mifepristone in ways designed to reach into jurisdictions like Louisiana.”
The legal challenge comes amid increased scrutiny of abortion medication from both political and regulatory perspectives. Department of Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary have already called for “a comprehensive safety review” of the 2023 mifepristone REMS, which Judge Joseph referenced in his decision.
Mifepristone has become the most common method of abortion in the United States, accounting for approximately 60% of all abortions according to Reuters. This prominence has made it a focal point in the ongoing national debate over abortion access following the Supreme Court’s Dobbs decision.
Pro-life advocates have urged for quicker action. “This is one of the many reasons why the investigation into the FDA must be sped up so that states can begin to regulate abortions if the feds don’t,” said Shawn Carney, President of 40 Days for Life. “We now know how dangerous these abortion drugs are.”
The case represents the latest development in the complex legal landscape surrounding abortion access in post-Dobbs America, with states, federal agencies, and the courts all navigating competing claims about state authority, federal regulation, and public health.
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7 Comments
This is certainly a complex and contentious issue. I’m glad to see the courts deferring to the FDA’s expertise and evidence-gathering process rather than hastily issuing injunctions.
The FDA’s upcoming safety review will be closely watched. I hope they can find a balanced solution that respects the law while also ensuring appropriate access and protections for patients.
This is a complex issue with valid concerns on both sides. I appreciate the judge’s focus on the FDA’s safety review rather than rushed litigation. Thoughtful policy should balance access, safety, and the rule of law.
This is a tricky situation with valid concerns on both sides. I’m glad to see the judge emphasize the importance of the FDA’s review process rather than rushed legal action.
The judge’s emphasis on the importance of the FDA’s review is encouraging. Maintaining access while ensuring safety is a delicate balance, and a measured approach seems prudent here.
A careful, evidence-based approach by the FDA is critical here. Both the availability and safety of this medication need to be fully considered before making any long-term changes.
The Supreme Court’s decision to allow mail-order access during the FDA’s review period seems like a reasonable compromise. Maintaining access while the safety evidence is thoroughly evaluated is important.