WASHINGTON, July 2, 2024
/PRNewswire/ --
Statement attributable to:
Octavia Peck Palmer, PhD
President, Association for Diagnostics & Laboratory Medicine
(formerly AACC)
"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 mpolen@myadlm.org 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.
Media contacts:
Christine DeLong
ADLM
Associate Director, Communications & PR
(p) 202.835.8722
cdelong@myadlm.org
Molly Polen
ADLM
Senior Director, Communications & PR
(p) 202.420.7612
(c) 703.598.0472
mpolen@myadlm.org
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SOURCE Association for Diagnostics & Laboratory Medicine
(ADLM)