Association for Diagnostics & Laboratory Medicine (formerly AACC) Statement on Proposed FDA Rule on Laboratory Developed Tests

Statement attributable to:

Octavia Peck Palmer, PhD

President, Association for Diagnostics & Laboratory Medicine (formerly AACC) 

“We at the Association for Diagnostics & Laboratory Medicine were disappointed to see the U.S. Food & Drug Administration’s (FDA’s) attempt to circumvent Congress with its new proposed rule to duplicate the regulation of laboratory developed tests by placing these tests under FDA authority, in addition to their current regulation under the Centers for Medicare and Medicaid Services. 

“Simply, this would create a dual, expensive, and potentially contradictory regulatory environment for clinical laboratories, eliminating most labs’ ability to perform laboratory developed tests and drastically limiting patients’ access to critical laboratory test results. 

“We continue to advocate for a balanced, evidence-based approach to regulating laboratory developed tests. We must identify what problems we are trying to fix and correct them without hindering scientific advancement or limiting patient access to these innovative, often life-saving tests. We urge the FDA to join us in working within the current regulatory system to advance patient care and prioritize health equity.” 

To speak to Dr. Peck Palmer about this issue, please contact Molly Polen, ADLM Senior Director of Communications & PR, at [email protected] or 202-420-7612.

About the Association for Diagnostics & Laboratory Medicine (ADLM)

Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.