ASCP Urges Trump Transition Team to Rescind FDA LDT Rule

ASCP has contacted the Trump transition team leaders to urge the incoming administration of President-elect Donald Trump to rescind the U.S. Food and Drug Administration’s (FDA) Final Rule claiming oversight authority over laboratory developed tests (LDTs).

In a letter to Linda McMahon and Howard Lutnick, co-chairs of the Trump transition team, ASCP President Greg Sossaman, MD, MASCP, noted that the previous Trump Administration ruled that the FDA should not regulate LDTs. In 2020, U.S. Health and Human Service Secretary Alex Azar blocked the FDA from exercising oversight over LDTs. Secretary Azar’s decision was based on a legal opinion drafted by the General Counsel of the U.S. Department of Health and Human Services, arguing that the FDA lacked sufficient statutory authority to provide oversight of LDTs. 

ASCP—which filed an amicus curiae brief in October in a lawsuit seeking to overturn the Final Rule and submitted congressional testimony earlier this year opposing both the Final Rule and the Verifying Accurate and Leading-edge IVCT Development Act, or VALID Act—believes that both the FDA Final Rule and the VALID Act fundamentally undermine patient access to quality care by imposing expensive and duplicative oversight burdens on clinical laboratories without improving patient outcomes.

By rescinding FDA’s Final Rule, ASCP President Sossaman expressed hope that President Trump’s leadership would send a clear message to both the FDA and Congress that LDTs are currently regulated appropriately in a manner that is nimble and free of excessive bureaucracy. This is provided by the Clinical Laboratory Improvement Amendments of 1988. To maintain the highest quality patient care, we must never discourage accredited clinical laboratories from developing and providing innovative, cost effective, quality laboratory services. 

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