Abortion pill mifepristone stays available by mail for now as FDA faces 6-month review deadline
A federal judge allowed the abortion pill mifepristone to continue being distributed by mail nationwide for now, but warned the Biden-era policy could soon face major legal changes as a Food and Drug Administration (FDA) safety review of the drug unfolds.
The legal challenge to the U.S. Food and Drug Administration's January 2023 Risk Evaluation and Mitigation Strategy (REMS) seeks to end the "certified pharmacies" regulation that allows for the drug to be mailed across state lines while the federal agency continues its review.
U.S. District Court Judge David C. Joseph, appointed by President Donald Trump, ruled against Louisiana Attorney General Liz Murrill on Tuesday, citing what he referred to as a "government by lawsuit."
"...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 in his ruling.
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Joseph also cited a letter from both Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary asking their respective agencies to "conduct a comprehensive safety review" of the 2023 mifepristone REMS.
Murrill told Fox News Digital she plans on taking Joseph's ruling to the Fifth Circuit despite the ongoing mifepristone REMS review from both agencies.
"Judge Joseph concluded that Louisiana has standing to sue and is likely to succeed in showing that the 2023 REMS is unlawful," Murrill said to Fox News Digital in a statement.
"He also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect," she added. "Accordingly, under binding Fifth Circuit precedent, the only thing left to do is vacate the 2023 REMS pending the outcome of this litigation. We will ask the Fifth Circuit to do so."
The ruling sets up a high-stakes legal fight over abortion pills, with a federal appeals court showdown looming and the FDA under pressure to justify rules that dramatically expanded access in recent years.
In the past year, many red states nationwide have taken the 2023 REMS mail-order regulation to the courts.
In one notable incident last year, a Texas man who fathered an unborn child sued a California doctor who prescribed his ex-girlfriend mifepristone through the organization "Aid Access." His case, Rodriguez v. Coeytaux, is still ongoing.
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In the State of Louisiana v. U.S. Food and Drug Administration, Murrill seeks a full rollback of the REMS policy regardless of the findings of the review.
Joseph denied injunction without prejudice in the suit that Louisiana brought to the court, but also granted stay of the case. His ruling orders the FDA to complete their safety review, which had been postponed through the November midterm elections, and to report back in six months.
"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 wrote in his ruling.
Joseph did point to Louisiana's standing in the suit, claiming the state is suffering "ongoing harm" after the Dobbs decision in 2022 allowed the state to ban abortion.
"Thus, in that post-Dobbs regulatory environment, there is evidence that the 2023 REMS was approved without adequate consideration, at least in part, as part of an effort to circumvent anti-abortion states’ ability to regulate abortion," Joseph wrote. "Likewise, there is evidence that 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."
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However, Joseph pointed to the FDA as the ultimate decision maker on the issue, as a matter of "public health judgment."
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, where the gestational age of the proposed pregnancy was lengthened to 10 weeks, and required fewer in-person visits to obtain a prescription.
After the COVID-19 pandemic, where mifepristone was prescribed and sent via mail under unprecedented circumstances, the same rules were legalized under the FDA's REMS in 2023.
Reuters reported that mifepristone is the single-most popular method of abortion in the U.S., representing about 60% of all abortions.
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Joseph's ruling orders the FDA to finish their review, which may revise rules under the 2023 REMS guidelines. It also allows the court to act if the agency continues to delay its safety review more than six months.
"Should the agency fail… the Court’s analysis… will inevitably change," Joseph concluded.
Joseph maintained mifepristone access in Louisiana for now, but signaled the legal and scientific basis for those rules may not hold.
"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," 40 Days for Life President Shawn Carney told Fox News Digital. "This was one of the great promises by RFK that they initiated last year, because we now know how dangerous these abortion drugs are."
"The investigation into the FDA must be sped up because every abortion pill sent through the mail is a huge, unregulated danger that has been a disaster since Biden deregulated it," Carney added.
The FDA did not immediately respond to Fox News Digital's request for comment.