Oct. 8, 2024—The College of American Pathologists on Oct. 7 filed an amicus brief in support of the plaintiffs in the consolidated cases American Clinical Laboratory Association, et al., v. U.S. Food and Drug Administration, et al., and Association for Molecular Pathology, et al., v. U.S. Food and Drug Administration, et al.
Plaintiffs in these consolidated cases challenge a final rule setting out the FDA’s plan to regulate LDTs as medical devices under the Federal Food, Drug and Cosmetic Act. “The Final Rule imposes draconian new restrictions—and crushing compliance costs—on the development and use of LDTs,” the CAP says in its amicus brief.
The CAP says in the brief that its “keen interest and deep experience in the practical issues surrounding LDT regulation will benefit the Court’s decision-making in this case.” In taking its “drastic action,” the CAP says of the FDA, it “failed to engage in the reasoned decision-making that the Administrative Procedure Act demands.”
The brief adds: “Reasonable regulation requires that an agency grapple with the negative consequences of its chosen path. Here, FDA instead found a way to ignore those consequences by asserting that its novel, complex, and nonbinding scheme of ‘enforcement discretion policies’ articulated in the Final Rule’s preamble would prevent the catastrophic consequences that so many stakeholders have predicted.” Yet the final rule never explains how the FDA’s “slew of explicitly nonbinding policies” will safeguard LDT innovation and access, the CAP says.
The CAP urged the U.S. District Court for the Eastern District of Texas to vacate the final rule as arbitrary and capricious.
CAP president Donald Karcher, MD, said the CAP filed the amicus brief because CAP members “fear these regulatory restrictions from the FDA will delay the diagnosis of disease and treatment of patients.” He added: “The CAP had communicated its concerns to the FDA prior to the release of the final rule and urged the agency to take a different tact. However, the FDA moved forward and now pathologists and their laboratories are having conversations about which LDTs will no longer be available to patients in their communities. The FDA’s failure to come to grips with the obvious ramifications on patients of the LDT regulation clearly renders the rulemaking arbitrary and capricious.”