Federal Appeals Court Blocks Mail Order for Abortion Drug

A federal appeals court has halted a plan from the Biden administration that would permit the abortion medication mifepristone to be sent through the mail. On Friday, a panel of three judges from the United States Court of Appeals for the Fifth Circuit strongly criticized the FDA’s 2023 changes to the Risk Evaluation and Mitigation Strategies (REMS) associated with the drug.

The panel asserted that the Biden administration’s move to eliminate the requirement for in-person dispensing reflects a clear effort to undermine state laws that protect fetal life, especially following the Supreme Court’s decision in Dobbs. They pointed out that the FDA acknowledges there is a lack of robust scientific backing for this decision.

Further, the court determined that Louisiana, which challenged the FDA regarding the mail order proposal, had the legal grounds to pursue the case, asserting that it faced potential irreparable harm and had a solid probability of winning the case. This opinion was penned by Circuit Judge Kyle Duncan, a Trump appointee, and supported by judges Leslie Southwick and Kurt Engelhart, both appointed by Republican presidents.

Duncan elaborated that the 2023 REMS harms Louisiana by diluting laws meant to protect unborn life and could result in Medicaid funds being used for emergency care for women adversely affected by mifepristone. The panel argued that the potential harm was irreversible.

The ruling emphasized that the actions facilitated by the FDA would effectively nullify Louisiana’s prohibition on medical abortions and contradict its policy that recognizes every unborn child as a legal entity from the moment of conception. Duncan cautioned that once this protective privilege is lost, it can’t be reclaimed through legal means, especially since the FDA enjoys sovereign immunity against claims of economic damage.

The FDA initially approved mifepristone in 2000, categorizing pregnancy as a “disease.” Back then, the REMS stipulated that only doctors could prescribe the medication after three in-person consultations. Safety regulations have since been loosened, culminating in the Biden administration making mailing options permanent in 2023.

In Louisiana, a woman named Rosalie Markesic claimed that her boyfriend forced her to take abortion pills that he ordered from California online. She, along with a company, filed a lawsuit against the FDA, alleging illegal actions by loosening safeguards related to mifepristone.

Duncan pointed out that, by lifting the in-person requirements, the FDA inadvertently facilitated nearly 1,000 illegal abortions monthly in Louisiana—a concerning statistic.

Moreover, Duncan noted that the FDA seemed to have disregarded safety data from its reporting system known as FAERS while making its decision to relax mifepristone’s dispensing mandates. He commented on the lack of reasonableness in eliminating adverse event reporting requirements while then citing the absence of data to defend the decision.

He also criticized the FDA for relying on various studies regarding remote prescribing of mifepristone, even stating that these studies did not offer explicit support for the FDA’s stance. This kind of decision-making, he added, showcases carelessness from government entities.

Despite the FDA under Trump not contesting the case’s merits, they sought to allow the mail-order program to continue while reviewing the drug’s safety. Some pharmaceutical firms got involved in the case, arguing that restricting mail order would have financial ramifications.

Earlier, a lower court had permitted the mail order procedure but acknowledged Louisiana’s strong chance of success on the merits of its case. Now, the federal appeals court has reversed that stance, blocking the regulation as litigation continues.

Duncan dissented from the previous court’s ruling, voicing that neither ongoing safety reviews nor the economic interests of the pharmaceutical firms outweighed the damage to Louisiana and other pro-life states.

“As we have seen multiple times, the FDA’s gradual relaxation of these safeguards likely lacks scientific basis. It’s not in the public interest to uphold practices that have been found to be inadequately researched,” he stated.

In the aftermath of the Fifth Circuit’s decision, the drug companies requested an emergency motion from the Supreme Court, seeking to reverse the appeals court’s ruling. Meanwhile, pro-choice advocates expressed dismay over the decision, warning of broader implications for abortion rights nationwide.

Following the ruling, Louisiana Attorney General Liz Murrill expressed her relief, characterizing the court’s decision as a welcome conclusion to a troubling chapter. She mentioned that the actions from the Biden administration facilitated dangerous situations for women and infants alike. This ongoing litigation aims to protect those vulnerable groups further.

A report from the Guttmacher Institute indicates that medication abortions made up a significant portion of all abortions in formal healthcare settings, increasing steadily over recent years without including those performed through unofficial channels.

Pro-choice organizations also estimate a notable rise in telemedicine abortions in states with strict abortion laws, highlighting a continuing trend of concern and legal debate surrounding this issue.