Advocacy - Lab Advocate
On June 23, the House Appropriations Committee approved its FY 2026 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill which includes report language that directs the Food and Drug Administration (FDA) to suspend enforcement of its final rule on laboratory-developed tests (LDTs).
The report language underscores congressional concern with the rule, stating that FDA’s framework represents a “significant shift” in LDT oversight that risks disrupting the nation’s laboratory testing infrastructure and limits patient access to critical health information. The committee’s stance aligns with a recent federal court decision invalidating FDA’s authority to regulate LDTs as medical devices and reflects growing bipartisan opposition to the agency’s approach in Congress.
ADLM continues to maintain that the Clinical Laboratory Improvement Amendments (CLIA) program is the appropriate mechanism for modernizing oversight of LDTs. The association has persistently communicated this position to Congress and regulators and has regularly joined with allied stakeholders across the healthcare community that support this position. ADLM will continue to advocate for a policy framework that supports innovation, protects patient access, and reflects the unique nature of laboratory testing.