Federal judge allows mifepristone mail access, orders 6-month FDA review

A federal judge has allowed mifepristone, an abortion pill, to continue to be distributed by mail nationwide for now, but warned that the Biden-era policy could soon face major legal changes as a review of the drug’s safety by the Food and Drug Administration (FDA) unfolds.

The legal challenge to the U.S. Food and Drug Administration’s January 2023 Risk Evaluation and Mitigation Strategy (REMS) seeks to end regulation of “certified pharmacies” that allows 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 Tuesday against Louisiana Attorney General Liz Murrill, citing what he called “government by trial.”

“…It is the completion of FDA’s promised good faith, evidence-based, and expeditious review of REMS to mifepristone, not ‘rule by litigation,’ that this Court finds to be in the public interest,” Joseph wrote in his decision.

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A federal judge on Tuesday allowed mifepristone, an abortion pill, to continue to be distributed by mail nationwide. (Evelyn Hockstein/Reuters, file)

Joseph also cited a letter from 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 that she plans to take Joseph’s decision to the Fifth Circuit despite the ongoing review of the mifepristone REMS by both agencies.

“Judge Joseph concluded that Louisiana has standing to sue and will likely succeed in demonstrating that REMS 2023 is illegal,” Murrill told Fox News Digital in a statement.

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Pro-life supporters rally outside the Supreme Court in Washington, DC (Olivier Douliery/AFP, File)

“It also concluded that Louisiana suffers irreparable harm every day while REMS 2023 remains in effect,” she added. “Accordingly, under the Fifth Circuit’s binding precedent, the only thing left to do is to overturn the 2023 REMS pending the outcome of this litigation. We will ask the Fifth Circuit to do so.”

The ruling sets off a high-stakes legal battle over abortion pills, with a looming showdown in federal appeals court and the FDA under pressure to justify rules that have dramatically expanded access in recent years.

Over the past year, many red states across the country have taken the 2023 REMS mail-order regulation to court.

In one notable incident last year, a Texas father of an unborn child sued a California doctor who prescribed mifepristone to his ex-girlfriend through the organization “Aid Access.” His case, Rodriguez v. Coeytaux, is still in progress.

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A federal judge ruled Tuesday against Louisiana Attorney General Liz Murrill, citing what he called “government by trial.” (Chris Graythen/Getty Images, file)

In the case of State of Louisiana v. US Food and Drug Administration, Murrill is calling for a complete rollback of the REMS policy, regardless of the review’s findings.

Joseph denied the without prejudice injunction in Louisiana’s lawsuit in court, but also granted a stay of the case. His decision orders the FDA to complete its safety review, which had been delayed until the November midterm elections, and report back in six months.

“If the agency fails to complete its review and make necessary revisions to the REMS within a reasonable time frame, the Court’s analysis – and the weight given to these factors – will inevitably change,” Joseph wrote in his decision.

Joseph highlighted Louisiana’s position in the lawsuit, saying the state suffers “continued harm” after the Dobbs decision in 2022 allowed the state to ban abortion.

“Thus, in this post-Dobbs regulatory environment, there is evidence that REMS 2023 was approved without adequate consideration, at least in part, as part of an effort to circumvent the ability of anti-abortion states to regulate abortion,” Joseph wrote. “Similarly, there is evidence that the consequences of this action were predictable: out-of-state providers and associated entities would expand access to mifepristone in ways that would reach jurisdictions like Louisiana.”

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Mifepristone was first approved by the FDA in 2000 under strict guidelines. (Charlie Neibergall/AP, file)

However, Joseph designated the FDA as the ultimate decision-maker on the matter, as a matter of “public health judgment.”

Mifepristone was first approved by the FDA in 2000 under strict guidelines, requiring pregnancy at seven weeks gestation or less, and administered only in person after being reviewed by a prescribing physician.

The guidelines were first relaxed in 2016, when 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, during which mifepristone was prescribed and mailed under unprecedented circumstances, the same rules were legalized under the FDA’s REMS in 2023.

Reuters reported that mifepristone is the most popular abortion method in the United States, accounting for about 60% of all abortions.

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A Kansas law requiring patients to be informed about medication abortion reversal regimens is one of two laws being challenged in a lawsuit filed by abortion providers. (Charlie Riedel/AP)

Joseph’s ruling orders the FDA to complete its review, which could revise the rules under the 2023 REMS guidelines. It also allows the court to act if the agency continues to delay its safety review for more than six months.

“If the agency fails…the Court’s analysis…will inevitably change,” Joseph concluded.

Joseph maintained access to mifepristone in Louisiana for now, but cautioned that the legal and scientific basis for these rules may not hold.

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“This is one of many reasons why the FDA investigation needs to be expedited so that states can begin to regulate abortions if the federal government does not,” 40 Days for Life President Shawn Carney told Fox News Digital. “This was one of the big promises RFK made last year, because we now know how dangerous these abortion drugs are.”

“The FDA investigation needs to be expedited because every abortion pill sent through the mail represents 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.