Advocacy - Lab Advocate
ADLM issued a letter to key congressional leaders on September 5, 2024, expressing significant concerns regarding the Foods and Drug Administration’s (FDA) May 2024 final rule on laboratory-developed tests (LDTs). The association collected input through surveys, revealing that over 60% of clinical laboratories fear they will not have the resources or staff to comply with the FDA’s stringent requirements. Many labs reported that they would be forced to discontinue LDT services, which are critical for diagnosing complex or rare diseases, particularly in rural or underserved communities where alternative testing options are scarce.
ADLM also highlighted that LDTs have long been regulated by CMS under the Clinical Laboratory Improvement Amendments (CLIA). The FDA’s new rule introduces duplicative oversight, creating unnecessary burdens for labs without improving patient outcomes. Nearly 90% of surveyed labs expressed a preference for CMS to continue regulating LDTs, given their established relationship with the agency and familiarity with its processes.
In its letter, ADLM urged Congress to rescind the FDA rule and work toward legislative alternatives that protect patient care while minimizing regulatory duplication. ADLM also called for an update to CMS standards for LDTs to ensure that regulatory oversight remains practical and effective, without placing unsustainable burdens on clinical laboratories. ADLM is committed to continuing its advocacy efforts to protect its members from excessive regulatory burdens and ensure that clinical laboratories can continue to deliver essential diagnostic services.