The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC), together with the American Association of Bioanalysts, American Society for Clinical Pathology, American Society for Microbiology, and the Infectious Disease Society of America, has filed an amicus brief in the case of American Clinical Laboratory Association (ACLA), et al. v. U.S. Food and Drug Administration (FDA), et al.
The brief supports ACLA’s position that the FDA’s final laboratory developed tests rule exceeds the agency’s statutory authority and urges the court to strike down the rule before it causes irreparable patient harm.
View the full amicus brief here: https://www.myadlm.org/~/media/Project/MyAdlm/myAdlm/Files/Health and Science Policy/Regulatory Issues/2024/Doc 40 Amici Brief by AAB et al O1542659xD07F1.pdf
Given the serious threat this rule poses to patient care, ACLA brought a lawsuit against the FDA on May 29 in a Texas federal court. ACLA states that it is challenging the final rule because the FDA has exceeded its statutory authority and acted arbitrarily and capriciously in violation of the Administrative Procedure Act.
The amicus brief filed by ADLM and its fellow clinical laboratory societies lays out a detailed argument in favor of ACLA’s suit and against the FDA’s final rule. First and foremost, the brief emphasizes that the rule is already having a negative impact on patient care — an impact that will only get worse with time. For example, the brief cites the case of a healthcare system that is reconsidering its plans to offer a vital infectious disease test that would be used to diagnose critically ill patients. The test is available at a reference laboratory, but sending patient specimens to the other lab and waiting for the result involves a turnaround time of several days. Bringing the test in-house could save patient lives because the results would be available much more quickly. But this healthcare system is hesitating to do this now because of the looming phase-in of the FDA rule.
The brief also argues that the FDA rule will stifle innovation in clinical testing, much of which is driven by laboratory developed tests. For instance, FDA-authorized test kits are often not made with children in mind. Pediatric hospitals therefore modify these test kits — turning them into laboratory developed tests — to ensure that they are appropriate for pediatric use. This has led to many advancements in pediatric care, such as in the diagnosis and management of pediatric cancers like leukemia and lymphoma. The FDA’s final rule will drastically curtail the ability of labs to innovate in this way, though, which will limit labs’ ability to provide new diagnostic tools that improve patient care.
