Nationwide Distribution of Mifepristone Allowed for Now
A federal judge has permitted the ongoing nationwide mail distribution of the abortion medication mifepristone. However, he cautioned that significant legal changes may be on the horizon as the FDA reviews the drug’s safety.
The challenge targets the FDA’s January 2023 Risk Evaluation and Mitigation Strategy (REMS), which includes a regulation that enables the mailing of medications between states while the review is in progress.
U.S. District Judge David C. Joseph, appointed during Trump’s presidency, ruled against Louisiana’s Attorney General Liz Murrill, decrying what he termed “government by litigation.” He emphasized that the public interest lies in the FDA’s duty to carry out a thorough, evidence-based review of mifepristone REMS rather than relying on legal battles.
Joseph referenced communications from Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty McCulley urging their agencies to undertake a detailed safety review of the 2023 REMS.
Murrill plans to appeal Judge Joseph’s decision to the 5th Circuit, despite the ongoing review process. In a statement, she suggested that the ruling confirmed Louisiana’s legal standing and likelihood of success in proving that the 2023 REMS is illegal.
Joseph pointed out that Louisiana claims to be experiencing ongoing harm as a result of the 2023 REMS, further solidifying their grounds for litigation.
This ruling highlights the intense legal struggle surrounding abortion medications, as federal appeals courts brace for additional scrutiny, and the FDA faces mounting pressure to account for rules that have notably increased access in recent years.
Over the past year, several conservative states have contested the 2023 REMS regulations in court. In a notable case from last year, a Texas man sued a California doctor for prescribing mifepristone to his ex-girlfriend through an organization known as Aid Access; that case remains unresolved.
In the State of Louisiana v. U.S. Food and Drug Administration case, Murrill is pressing for the complete repeal of the REMS policy, independent of the review’s outcome.
Joseph has denied Louisiana’s request for an injunction but has granted a stay in the lawsuit. He instructed the FDA to finalize its safety review, which had been postponed until after the November midterms, and submit a report within six months.
“Should the agency fail to complete its review and make necessary changes within a reasonable timeframe, the court’s position will inevitably shift,” Joseph noted in his ruling.
He acknowledged Louisiana’s arguments about ongoing harm post-Dobbs, indicating that the 2023 REMS might have been approved without proper consideration. He also mentioned predictable outcomes, such as out-of-state providers extending access to mifepristone, particularly impacting jurisdictions like Louisiana.
Joseph underscored that ultimately, the FDA has the final say regarding public health matters. Initially approved in 2000 under strict regulations, mifepristone’s guidelines have previously been eased, allowing wider access to the medication.
The medication, used in about 60% of abortions in the U.S., has seen relaxed rules since its initial approval, notably due to the COVID-19 pandemic, which spurred changes that facilitated mailing prescriptions.
Joseph’s ruling necessitates an expedited FDA review that could adjust the 2023 REMS guidelines. It empowers courts to intervene if a government agency delays a safety review for over six months.
While Joseph’s ruling currently maintains access to mifepristone in Louisiana, he suggested that the legal basis for these rules may not withstand future scrutiny.
Industry voices, including advocates for pro-life regulations, are calling for tighter safety protocols concerning abortion medications, emphasizing an urgent need for investigations into the FDA’s role in this ongoing situation.
