Advocacy - Lab Advocate
ADLM continues to take a leadership role in opposing the Food and Drug Administration’s (FDA) efforts to extend its oversight to include laboratory developed tests (LDTs). LDTs are currently regulated by the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA). These tests, which are used within a single laboratory, occupy the cutting edge of personalized medicine, and are often developed to guide patient care when no other approved test exists. LDTs have traditionally operated under the CLIA framework, ensuring they meet high standards for reliability and safety.
In October, the FDA published a proposed rule that would unilaterally impose an additional layer of oversight on top of CLIA. This initiative has generated a significant backlash within the healthcare community. ADLM has asserted that the proposal, if implemented, would stifle innovation and access to critical diagnostic services. Dr. Octavia Peck Palmer, the current President of ADLM, outlined the association’s concerns in testimony to the Energy & Commerce (E&C) Subcommittee on Health.
ADLM also argues that FDA regulation of LDTs would introduce a redundant, burdensome, costly layer of regulation, which could compel laboratories to discontinue offering these indispensable tests - directly impacting patient access to potentially life-saving care. Furthermore, ADLM remains staunchly opposed to the VALID Act, legislation that would grant the FDA explicit authority over LDTs.
ADLM continues to advocate for a balanced approach that prioritizes patient safety while maintaining the availability of state-of-the-art laboratory services. The association advocates for updating LDT oversight within the existing CLIA framework in a manner that continues to support innovation, enhances patient safety, and maintains access to these critical diagnostic services.