ADLM urges HHS not to appeal ruling on LDT oversight

On May 12, ADLM joined other leading medical organizations in a letter to the U.S. Department of Health and Human Services (HHS) urging the agency not to appeal a recent federal court ruling that vacated the FDA’s final rule asserting authority over laboratory-developed tests (LDTs).

The letter followed the April 30 decision by Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas in American Clinical Laboratory Association et al. v. FDA, which found that the Food and Drug Administration (FDA) exceeded its statutory authority under the Federal Food, Drug, and Cosmetic Act (FDCA) by attempting to regulate LDTs as medical devices. ADLM joined other leading medical and laboratory stakeholders in submitting an amicus brief in the case, urging the court to recognize the limitations of FDA's statutory authority over LDTs. The court affirmed that LDTs fall under the purview of the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare and Medicaid Services (CMS).

In the letter, ADLM and fellow signatories emphasized that FDA regulation would impose duplicative, costly, and burdensome requirements on clinical laboratories—without improving patient outcomes. These barriers could threaten access to thousands of LDTs that are vital for patients, particularly in cases where no FDA-approved alternatives exist. The court noted that compliance costs for laboratories would exceed $1 billion annually under the FDA’s vacated rule.

May 31 marked the deadline for the FDA to appeal the ruling. The agency did not appeal, signaling a major shift in its long-standing position asserting oversight of LDTs through guidance and enforcement discretion.

This outcome has broad implications for the future of LDT oversight, including renewed attention to legislative proposals such as the VALID Act. ADLM will continue to advocate for an approach that protects patient access to high-quality laboratory-developed testing services without unnecessary regulatory burdens.