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

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

A legal challenge to the U.S. Food and Drug Administration’s January 2023 Risk Evaluation and Mitigation Strategy (REMS) aims to end the “certified pharmacies” regulation that allows medication 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 she called “government by litigation.”

“…This Court is not “government by litigation,” but rather the completion of the good faith, evidence-based, expedited review of mifepristone REMS that the FDA has promised,” Joseph wrote in his decision.

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Joseph also served as Secretary of the Department of Health and Human Services (HHS) Robert F. Kennedy Jr. and also cited a letter from FDA Commissioner Marty Makary asking relevant agencies to “conduct a comprehensive safety review” for the 2023 mifepristone REMS.

Murrill told Fox News Digital that he plans to appeal Joseph’s decision to the Fifth Circuit, despite ongoing REMS review of mifepristone from both agencies.

“Judge Joseph concluded that Louisiana has the right to sue and will likely succeed in showing that the 2023 REMS is illegal,” Murrill said in a statement to Fox News Digital. he said.

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Pro-life supporters gather outside the Supreme Court in Washington, D.C. (Olivier Douliery/AFP, File)

“He also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect,” he added. “Accordingly, under binding Fifth Circuit precedent, the only course of action is to vacate the 2023 REMS pending the outcome of this case. We will ask the Fifth Circuit to do so.”

The decision set off a risky legal battle over abortion pills; A showdown is looming in federal appeals court, and the FDA is under pressure to justify rules that have dramatically expanded access in recent years.

Last year, many red states across the country took the 2023 REMS mail order regulation to the courts.

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

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A federal judge ruled against Louisiana Attorney General Liz Murrill on Tuesday, citing what she called “government by lawsuit.” (Chris Graythen/Getty Images, File)

In State of Louisiana v. U.S. Food and Drug Administration, Murrill is seeking a complete reversal of the REMS policy, regardless of the findings of the review.

Joseph denied without prejudice a preliminary injunction in Louisiana’s lawsuit against the court, but also allowed the case to be postponed. His decision orders the FDA to complete the safety review, which was delayed because of the November midterm elections, and to report back in six months.

“If the Agency does not complete its review and make the necessary corrections to the REMS within a reasonable period of time, the Court’s analysis and the weight given to these factors will inevitably change,” Joseph wrote in his decision.

Joseph noted Louisiana’s stance on the case, claiming the state suffered “ongoing harm” after Dobbs’ 2022 ruling allowed the state to ban abortions.

“Thus, in the 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 impede the ability of anti-abortion states to regulate abortion,” Joseph wrote. “Likewise, there is evidence that the consequences of this action are foreseeable – out-of-state providers and related organizations will expand access to mifepristone through methods designed to reach jurisdictions such as Louisiana.”

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

However, Joseph noted that the FDA is the final decision-maker on the matter as a matter of “public health decision.”

Mifepristone was first approved by the FDA in 2000 under strict rules requiring a gestation period of seven weeks or less and was administered in person only after being seen by the prescribing physician.

The guidelines were first relaxed in 2016, extending the recommended gestational age of pregnancy to 10 weeks and requiring fewer in-person visits to obtain prescriptions.

Following the COVID-19 pandemic, where 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, representing about 60% of all abortions.

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

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

Joseph concluded: “Should delivery fail… the Court’s analysis… will inevitably change.”

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

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“This is one of the many reasons why the investigation into the FDA is being stepped up so that states can start regulating abortions if the feds don’t regulate,” 40 Days for Life President Shawn Carney told Fox News Digital. “This was one of the big promises that RFK launched last year, because now we know how dangerous these abortion drugs are.”

“The FDA investigation needs to be expedited because every abortion pill sent through the mail is a major, unregulated danger that has become a disaster since Biden deregulated it,” Carney added.

The FDA did not immediately respond to Fox News Digital’s request for comment.