US Judge Temporarily Halts Louisiana’s Challenge to FDA Abortion Drug Rule

US Judge Temporarily Halts Louisiana’s Challenge to FDA Abortion Drug Rule

A federal judge on Tuesday temporarily halted the state of Louisiana’s lawsuit aimed at restricting nationwide access to the abortion pill Mifepristone while President Donald Trump’s administration reviews the drug’s safety.

U.S. District Judge David Joseph in Lafayette, Louisiana, stated that the Republican-led state’s challenge to a 2023 rule permitting mifepristone to be distributed by mail should not move forward until the U.S. Food and Drug Administration determines whether it will revoke or maintain the regulation.

“At this juncture, it is the completion of FDA’s promised good faith, ​evidence-based, and expeditious review [and] not ‘government by lawsuit’ that this Court finds to be in the public interest,” wrote Joseph, a ​Trump appointee.

The state had requested that the judge block the 2023 rule while its lawsuit was ongoing, but David Joseph denied that request. However, he noted that the state could renew its effort once the case resumes and indicated that he would likely consider granting it at that time.

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The judge also pointed out that the New Orleans-based United States Court of Appeals for the Fifth Circuit had previously ruled that earlier rules from the U.S. Food and Drug Administration, which expanded access to Mifepristone, were unlawful. However, the Supreme Court of the United States later determined that the plaintiffs in that case did not have the legal standing to challenge those rules, without addressing the substance of the claims.

The U.S. Food and Drug Administration began a review of Mifepristone first approved in 2000 and now used in about 60% of abortions in the United States last year, though the process has reportedly been delayed until after the November midterm elections.

Liz Murrill, Louisiana’s Republican attorney general, said in a statement that her office plans to appeal the decision by David Joseph and will ask the United States Court of Appeals for the Fifth Circuit to block the 2023 rule.

Since the Supreme Court of the United States overturned the constitutional right to abortion in 2022, nearly half of U.S. states have banned or heavily restricted access to the procedure. This shift has led to a significant increase in medication abortions and sparked ongoing legal disputes over access to these drugs.

Medication abortion typically involves a two-drug process using Mifepristone followed by Misoprostol to end a pregnancy within the first 10 weeks. A 2023 FDA rule removed the requirement that these medications be dispensed in person, allowing them to be provided through other means such as mail distribution.

Liz Murrill’s office filed a lawsuit against the U.S. Food and Drug Administration in October, alleging that the agency overlooked potential safety risks when it expanded access to Mifepristone. In addition, five other Republican-led states have launched broader legal challenges targeting regulations related to the drug, including the FDA’s original approval granted in 2000.

The FDA, in response, asked David Joseph to pause Louisiana’s case while it completes its ongoing review, and has also argued that the state does not have the legal standing to pursue the lawsuit.

Meanwhile, Louisiana and Texas have taken further action by suing or indicting healthcare providers from other states who prescribed mifepristone to their residents. These cases are testing so-called “shield laws” in states like New York and California, which are designed to protect providers from out-of-state investigations and legal action.

Pharmaceutical companies GenBioPro and Danco Laboratories have also stepped into the case to support the FDA’s regulation. In court filings, both companies argued that there is no scientific evidence justifying a reversal of the FDA’s 2023 decision to remove the requirement for in-person dispensing of mifepristone.

The brand-name version of mifepristone, Mifeprex, is Danco’s only product, and GenBioPro derives most of its revenue from the ​generic version, the companies said in the filings.

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