Statement attributable to:
Octavia Peck Palmer, PhD
President, Association for Diagnostics & Laboratory Medicine (formerly AACC)
News — “On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the so-called Chevron doctrine and reinforced that Congress and the courts are responsible for writing and interpreting laws, respectively, not federal agencies. In response to this landmark decision, Representative Bill Cassidy, MD (R-La.), sent a letter to the Food and Drug Administration (FDA) today asking how the agency plans to implement this new framework, especially considering the fact that, under this new ruling, many of the agency’s actions in recent years are now officially considered to be outside the bounds of its authority.
“One of these actions, which Rep. Cassidy uses as an example in his letter, is the FDA’s decision to publish a final rule bringing laboratory developed tests under FDA oversight even though Congress hasn’t granted the FDA authority to do this. Laboratory developed tests are already regulated by the Centers for Medicare & Medicaid Services (CMS) via the Clinical Laboratory Improvement Amendments, and we at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) have long asserted that dual FDA-CMS regulation of these tests will be burdensome and costly for clinical labs. It will force many labs to stop performing these essential tests, which would have a tremendous negative impact on patient care.
“ADLM, therefore, strongly supports Rep. Cassidy’s letter to the FDA, and we appreciate that he asks the agency in great detail how it plans to change its current practices to enforce the laws as Congress writes them, instead of improperly legislating via agency action. We look forward to the FDA’s answers to Rep. Cassidy’s questions. In particular, we hope the agency will take this opportunity to halt its laboratory developed tests rule. We encourage the FDA to instead bring up this issue with the Clinical Laboratory Improvement Advisory Committee, which is the appropriate venue for discussing changes to current laboratory standards—a move that would be in concordance with the Loper Bright decision.”
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 laboratory developed tests
A laboratory developed test is a new or significantly modified test that is developed, validated, and used by highly trained laboratorians within a single clinical laboratory in response to a specific patient care need. Most laboratory developed tests are created because no Food and Drug Administration-approved test is available. Laboratory developed tests are often used to diagnose rare conditions, such as inherited genetic disorders. These tests are typically not advertised or sold as kits to other testing facilities.
The only labs that are allowed to perform laboratory developed tests are those that are considered high-complexity labs under the Clinical Laboratory Improvement Amendments, which are administered by the Centers for Medicare & Medicaid Services (CMS). These high-complexity labs are subject to rigorous oversight under CMS, and they are routinely inspected to ensure that they provide highly accurate testing.
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.
RSS