The American Society for Clinical Pathology has contacted President-elect Donald Trump’s transition team leaders, urging them to rescind the FDA Final Rule claiming oversight authority over laboratory-developed tests.

The American Society for Clinical Pathology (ASCP) President Greg Sossaman, MD, MASCP, sent a letter to transition co-chairs Linda McMahon and Howard Lutnick. He highlighted that, in 2020, Health and Human Services (HHS) Secretary Alex Azar blocked FDA oversight of laboratory-developed tests (LDTs), citing a legal determination from HHS General Counsel that the agency lacked sufficient statutory authority for such regulation.

The ASCP also filed an amicus curiae brief in October in a lawsuit challenging the FDA’s Final Rule and provided congressional testimony earlier this year opposing both the Final Rule and the Verifying Accurate and Leading-edge IVCT Development Act (VALID Act).

The organization expressed concerns that the FDA’s Final Rule and the VALID Act would impose burdensome and duplicative oversight requirements on clinical laboratories, which are already regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

Dr. Sossaman emphasized that rescinding the FDA’s Final Rule would affirm to both the FDA and Congress that existing CLIA regulations are adequate for ensuring LDT quality without discouraging laboratory innovation or compromising patient care.

Reference:
ASCP calls on Trump transition team to block FDA LDT oversight rule. [news] ASCP News. 2024;Nov 12. https://www.ascp.org/news/ascp-urges-trump-transition-team