CEI joins Coalition for Innovative Laboratory Test, FDA’s laboratory developed tests rule

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Re:     Court vacating FDA’s final rule on LDT regulation, Executive Order 14219, Executive Order “Reducing Anti-Competitive Regulatory Barriers”, & FDA Regulation of Laboratory Developed Tests

Commissioner Makary:

The undersigned leaders of clinical diagnostic laboratories from throughout the U.S. are united in opposition to

FDA’s attempts to impose burdensome and unnecessary regulation of laboratory developed tests (“LDTs”).

Considering the March 31, 2025 ruling by the U.S. District Court for the Eastern District of Texas in the matters of ACLA v FDA and AMP v FDA whereby the court granted the plaintiffs’ motion for summary judgement and ordered that “The final rule is hereby SET ASIDE and VACATED,” we urge FDA to immediately initiate compliance with the order through the required process to completely remove its May 6, 2024 final rule on regulation of LDTs from the Code of Federal Regulations. Further, in light of the President’s February 19, 2025 Executive Order 14219 titled “Ensuring Lawful Governance And Implementing The President’s “Department Of Government Efficiency” Deregulatory Initiative” requiring agencies to rescind, modify, or de-prioritize such regulations, and the April 9, 2025 Executive Order titled “Reducing Anti-Competitive Regulatory Barriers” requiring agency heads to identify anti-competitive regulations, we ask that the FDA also proactively exclude LDTs from the definition of either a “Medical Device” or “In Vitro Diagnostic.”

Specifically Executive Order 14129 requires Agency heads, within 60 days, to identify regulations that inter alia

meet one or more of the following criteria:

  • Lacking in underlying statutory authority
  • Impose significant costs upon private parties that are not outweighed by public benefits
  • Harm the national interest by significantly and unjustifiably impeding technological innovation, infrastructure development, disaster response, inflation reduction, research and development, and economic development
  • Impose undue burdens on small businesses and impede private enterprise and entrepreneurship.

Further, the as yet un-numbered Anti-Competition Executive Order requires Agency heads, within 70 days, to provide to the Chairman of the Federal Trade Commission and the Attorney General a list of regulations identified as being anti-competitive as follows:

  • Creates or facilitates the creation of de facto or de jure monopolies
  • Creates unnecessary barriers to market entry
  • Limits competition or has the effect of limiting competition between competing entities
  • Creates licensure or accreditation requirements that limit competition
  • Limits companies’ ability to compete for procurement
  • Or otherwise restrains or distorts the operations of the free market

Our collective view is that the FDA’s efforts to regulate LDTs meet all the above criteria. Specifically, the subject rule (a) lacks statutory authority, (b) is unnecessary and unjustified, (c) would impose enormous costs on clinical labs, especially those that are small businesses, forcing us to curtail innovative test development and commercialization and many to go out of business, (d) is anti-competitive and creates unnecessary barriers to market entry, (e) would require the FDA to expand its workforce to implement and administer when the Administration has called for a 3,500 reduction in the FDA workforce, and (f) would hurt patients and efforts by FDA and its sister healthcare agencies to “Make America Healthy Again.” With respect, the undersigned individuals, laboratories, and interested organizations hereby support and request your attention to this matter.

Maryanne Amato

Accu Reference Medical Laboratory

Brian Kunkel

MBA, MLS(ASCP), CSSBB

Acupath Laboratories, Inc.

Leanord Scinto

Advancing Health Laboratories, LLC

Oral Alpan

MD Amerimmune

Ryan Fortna

Avero Diagnostics

Jerry Conway

Belay Diagnotics

Ahmer Kodvawala

Biotivate

Daniela Peterova

Capital Health Lab & Synergy Medical Lab

Balu Chacko

Ph.D.

Chesapeake Clinical Laboratories

Dough Masters

PhD Circulogene

Maria Sue Abiera

Clinical Laboratory Scientist Consulting, LLC

David S. McFadden

Competitive Enterprise Institute

Cha-Mei Tang

Sc.D. Creatv MicroTech, Inc.

Nina Bau

Elite Diagnostics, LLC

Francine Jackson

EquipNet

Ruben Bonilla Guerrero

Genetica Consulting Services

Jonathan Cohen

Genesis Biolabs

Nicole Moberg

Genesis Reference Laboratories

Patrick Bohan

Gesher Consulting, LLC

Mike Friez

Greenwood Genetic Center

Hema Kapoor

HK Healthcare Consultant, LLC

Devyn Stumbo

Innovative Lab Services

Mohammad R Ali

Integrated Molecular Diagnostics Laboratory

Heba Attia

Labcare Diagnostics

Cheryl Yoder

Laboratory Consultant and Collaboration Services

Matthew Beckman

Logistic & Distribution, LLC (dba GENETWORX)

DuChess Voma

Lab2Doctors

Julie McCann

Nebraska Methodist Health System – Pathology

Thomas Reynolds

Next Molecular Analytics

Kyle Koeppler

nuCARE Medical Solutions, Inc.

Hari Nair

NyLa Laboratories

Ronald Blum, Ph.D.

Omni Pathology

Chandresh Patel

OnPoint Lab, LLC

Megan Sponsler

Pharma GenLabs, LLC

Bronwyn Ramey, PhD, MB(ASCP)CM, CGMBS,

HCLD(ABB)

Phoenix Laboratory Consulting, LLC

Akram Gorgi

Randox Health, CA

Matthew Gombrich

Renascent Diagnostics

Roz Miltenberger, PhD

MBA, HCLD(ABB)

RMdx Clincal LLC

Brendan Rainsford

RWJBarnabas Health

Gregory A. Stein

Shadowbox, Inc.

Grigor Tagakchyan

Summit Laboratory, Inc.

Yatin Thakore

TechnologyPark.com

Stan Schofield

The Compass Group

John Ramos

Toci Labs

Marcellino Porto

Trinity Medical Laboratories

Nader Bidgeli

UC Irvine

April Mathis

UVA Health

Cecil James Buguis

Winkler County Hospital District

Mayya Abdullayeva

Edward Ellsworth, MD

Nad Pathirana