Federal judge allows access to mifepristone email, orders 6-month FDA review
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A federal judge has allowed the abortion pill mifepristone to continue to be distributed by mail nationwide for now, but warned that the Biden-era policy could face major legal changes as the Food and Drug Administration (FDA) reviews the drug’s safety.
The January 2023 legal challenge to the US Food and Drug Administration, the Risk Evaluation and Mitigation Strategy (REMS) seeks to end the “certified pharmacy” regulation that allows the drug to be mailed across state lines while the federal agency continues its review.
US District Court Judge David C. Joseph, an appointee of President Donald Trump, ruled against Louisiana Attorney General Liz Murrill on Tuesday, citing what he called “the government for suing.”
“…It is the completion of the FDA’s promised good faith, evidence-based, and prompt review of the REMS for mifepristone, not “the government by suing,” 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 the abortion pill mifepristone to continue to be distributed by mail nationwide. (Evelyn Hockstein/Reuters, File)
Joseph also cited a letter from both 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 he plans to take Joseph’s decision to the Fifth Circuit despite ongoing reviews of the mifepristone REMS from both agencies.
“Judge Joseph concluded that Louisiana has standing to sue and is likely to succeed in showing that the 2023 REMS is unconstitutional,” Murrill told Fox News Digital in a statement.
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Pro-life supporters gather outside the Supreme Court in Washington, DC (Olivier Douliery/AFP, File)
“He also concluded that Louisiana is suffering irreparable harm every day that the 2023 REMS is in effect,” he added. “Accordingly, under Fifth Circuit precedent, all that remains to be done is to vacate the 2023 REMS pending the outcome of this case. We will ask the Fifth Circuit to do so.”
The ruling sets up a high-profile legal battle over the abortion pill, with the appeals court likely to be contentious and the FDA under pressure to uphold regulations that have expanded access in recent years.
Over the past year, several red states across the country have taken the 2023 REMS mail order regulation to court.
In one notable case last year, a Texas man who gave birth to an unborn child sued a California doctor who prescribed mifepristone to his ex-girlfriend through the organization “Aid Access.” His case, Rodriguez v. Coeytaux, still in progress.
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A judge ruled against Louisiana Attorney General Liz Murrill on Tuesday, citing what she called “the government for suing.” (Chris Graythen/Getty Images, File)
In State of Louisiana v. US Food and Drug Administration, Murrill is calling for a full reversal of the REMS policy regardless of the review’s findings.
Joseph denied the ban without prejudice in the case brought by Louisiana to the court, but he also agreed that the case should be stayed. His decision directs the FDA to complete its safety review, which had been postponed until the November midterm elections, and report back in six months.
“If the agency fails to complete its review and make any required revisions to REMS in a timely manner, the Court’s analysis — and the weight given to these factors — will inevitably change,” Joseph wrote in his decision.
Joseph pointed to Louisiana’s position in the case, saying the state faces “continuing harm” after the 2022 Dobbs decision allowed the state to ban abortion.
“Thus, in that post-Dobbs regulatory environment, there is evidence that REMS 2023 was adopted without sufficient consideration, at least in part, as part of an effort to circumvent the ability of anti-abortion states to regulate abortion,” Joseph wrote. “Likewise, there is evidence that the effects of this action were predictable – out-of-state providers and related organizations will expand access to mifepristone in ways designed to reach places like Louisiana.”
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Mifepristone was first approved by the FDA in 2000 under strict guidelines. (Charlie Neibergall/AP, File)
However, Joseph referred to the FDA as the ultimate decision maker in this matter, as a matter of “public health decision.”
Mifepristone was first approved by the FDA in 2000 under strict guidelines, requiring pregnancy to be seven weeks pregnant or less, and to be prescribed only after being seen by a prescribing physician.
The guidelines were first relaxed in 2016, when the gestational age for a proposed pregnancy was increased to 10 weeks, and require fewer in-person visits to obtain a prescription.
After the COVID-19 pandemic, when mifepristone was prescribed and sent by mail under unprecedented conditions, similar regulations were made into law under FDA’s REMS in 2023.
Reuters reported that mifepristone is the single most popular abortion method in the US, accounting for nearly 60 percent of all abortions.
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A Kansas law requiring patients to be informed about reversible medical abortions is one of two being challenged in court by abortion providers. (Charlie Riedel/AP)
Joseph’s ruling directs the FDA to complete its review, which may revise the regulations under the 2023 REMS guidelines. It also allows the court to take action if the agency continues to delay its safety review for more than six months.
“If the agency fails… the Court’s analysis… will definitely change,” Joseph concluded.
Joseph maintained access to mifepristone in Louisiana for now, but he signed off on the legal and scientific basis for those laws that may not hold.
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“This is one of the many reasons why the FDA investigation needs to be expedited so that states can start regulating abortion if the feds don’t,” said 40 Days for Life President Shawn Carney told Fox News Digital. “This was one of RFK’s good promises that they started last year, because now we know how dangerous these abortion drugs are.”
“The investigation by the FDA must be expedited because all mail-order abortion pills are extremely dangerous, out of control that has been a disaster since Biden lost control,” Carney added.
The FDA did not immediately respond to Fox News Digital’s request for comment.
