A federal judge has ruled that the abortion pill mifepristone will remain available for mail-order distribution nationwide for now, while ordering the Food and Drug Administration to complete a safety review of the drug within six months.
U.S. District Court Judge David C. Joseph, appointed by President Donald Trump, denied a request from Louisiana Attorney General Liz Murrill to block the FDA's 2023 Risk Evaluation and Mitigation Strategy (REMS) that allows mifepristone to be mailed across state lines. In his ruling, Joseph cited what he called "government by lawsuit" and said the appropriate path forward is through the FDA's ongoing safety review.
The judge referenced a letter from Department of Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary requesting a comprehensive safety review of the 2023 mifepristone REMS. Joseph ordered the FDA to complete its review and report back in six months.
What the Left Is Saying
Abortion rights advocates have defended the 2023 REMS as a necessary expansion of access to medication abortion. Supporters argue that mifepristone is safe and effective, and that restricting mail-order distribution would disproportionately harm women in states with abortion bans.
The ruling drew support from groups who argued that court challenges to FDA regulatory decisions should be left to the agency's scientific review process. Pro-abortion rights organizations have maintained that medication abortion using mifepristone is one of the safest medical procedures available, and that the 2023 policy simply codified practices that became common during the COVID-19 pandemic.
What the Right Is Saying
Louisiana Attorney General Liz Murrill, who brought the lawsuit, said she plans to appeal the ruling to the Fifth Circuit Court of Appeals. Murrill argued that Louisiana has standing to sue because the state suffers ongoing harm from the 2023 REMS, which she called unlawful.
In her statement to Fox News Digital, Murrill said: "Judge Joseph concluded that Louisiana has standing to sue and is likely to succeed in showing that the 2023 REMS is unlawful. He also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect."
Pro-life organizations have called on HHS and FDA to suspend the abortion pill approval and tighten safety rules. These advocates argue that the 2023 REMS was approved without adequate consideration of state sovereignty over abortion regulation following the Dobbs decision.
What the Numbers Show
Mifepristone was first approved by the FDA in 2000 under strict guidelines, requiring a pregnancy at seven weeks' gestation or fewer and only administered in-person after being seen by a prescribing physician. The guidelines were first relaxed in 2016, when the gestational age was extended to 10 weeks and fewer in-person visits were required.
According to Reuters, mifepristone is the most popular method of abortion in the United States, representing approximately 60% of all abortions. The 2023 REMS codified mail-order distribution practices that began during the COVID-19 pandemic.
Judge Joseph noted in his ruling that there is evidence the 2023 REMS was approved in part as an effort to circumvent anti-abortion states' ability to regulate abortion following the 2022 Dobbs decision that allowed states to ban abortion.
The Bottom Line
The ruling sets the stage for a high-stakes legal and regulatory battle over medication abortion. While mifepristone will remain available by mail for now, the six-month deadline puts significant pressure on the FDA to complete its safety review. If the agency fails to complete its review within a reasonable timeframe, Judge Joseph indicated the court's analysis would "inevitably change." The case is likely to reach the Fifth Circuit, which will ultimately decide whether the 2023 REMS remains in effect while litigation continues.