Rescind the Rule

Whilst the USA waits to learn how President-elect Trump’s administration plans to shake up the healthcare sector, the American Society for Clinical Pathology (ASCP) is already asserting its advocacy powers on the incoming transition team. In a letter to Linda McMahon and Howard Lutnick, co-chairs of the Trump transition team, ASCP President Greg Sossaman has urged the incoming administration to overturn the FDA’s Final Rule on regulation of laboratory developed tests (LDTs).

Noting that the previous Trump administration opposed the FDA’s proposal to take control of LDT approvals, Sossaman expressed hope that the incoming team would rescind the rule on the basis that it undermines patient access to quality care.

In the letter, Sossaman stressed 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 compromising patient care. A press release from ASCP states, “We must never discourage accredited clinical laboratories from developing and providing innovative, cost effective, quality laboratory services.”

In October, the ASCP joined four other medical specialty societies to file an amicus curiae brief seeking to overturn the Final Rule. It maintained that the FDA exceeded its authority in regulating LDTs as medical devices, which imposes expensive burdens on clinical laboratories without improving patient outcomes. This followed similar concerns raised by ASCP in congressional testimony to the House Energy and Commerce Committee in April, opposing both the Final Rule and the Verifying Accurate and Leading-edge IVCT Development (VALID) Act.

ASCP CEO, E. Blair Holladay, says, “In the year ahead we will continue to focus advocacy efforts on rescinding this rule and ensuring that patient care remains at the forefront of not only pathology and laboratory medicine, but for healthcare overall.”