Association for Diagnostics & Laboratory Medicine (formerly AACC) files an amicus brief backing the American Clinical Laboratory Association’s lawsuit against the FDA

WASHINGTON – Today, 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

On May 6, the FDA published a final rule on laboratory developed test regulation that will phase in FDA oversight of these essential tests over the next 4 years. However, Congress has never granted the FDA authority to regulate the expert testing services that clinical laboratories provide, which are already subject to rigorous oversight under the Centers for Medicare & Medicaid Services (CMS). Even more concerning is the fact that most labs do not have the resources to meet the FDA’s regulatory requirements on top of CMS’. This means that this duplicative regulation will push many labs to stop performing these vital tests, which in turn could lead to life-altering delays in diagnosis and treatment. 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. 

“We at ADLM commend ACLA for acting to safeguard patient access to laboratory developed tests,” said ADLM President Dr. Anthony Killeen. “Along with our partners, we are pleased to support ACLA in helping explain to the court, not only how the FDA has exceeded its authority, but also why the agency’s unilateral action is so detrimental to patient care. While we fully support FDA’s goal of making sure that laboratory developed tests are safe and accurate, a much more effective way to achieve this goal would be to review and update CMS’ existing standards. We look forward to the court’s resolution of this important case, and we hope that it will pave the way for a better solution to this issue.”

About laboratory developed tests

A laboratory developed test is a new or significantly modified test that is developed, validated, and used within a single clinical laboratory in response to a specific patient care need. Most laboratory developed tests are created because there is not already a Food and Drug Administration-approved test available, and they are often used to diagnose rare conditions, such as inherited genetic disorders. These tests are typically not advertised or sold as kits to other testing facilities.

The only labs that are allowed to perform laboratory developed tests are those that are considered high-complexity labs under the Clinical Laboratory Improvement Amendments, which are administered by the Centers for Medicare & Medicaid Services (CMS). These high-complexity labs are subject to rigorous oversight under CMS, and they are routinely inspected to ensure that they provide highly accurate testing.

About the Association for Diagnostics & Laboratory Medicine (ADLM)

Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.