ASCP and four other medical specialty societies are united in
support of the lawsuits filed by both the American Clinical
Laboratory Association and the Association of Molecular
Pathology.
WASHINGTON, Oct. 8, 2024
/PRNewswire-PRWeb/ -- Today the American Society for Clinical
Pathology (ASCP) filed an amicus curiae brief in a lawsuit seeking
to overturn the U.S. Food and Drug Administration (FDA) Final Rule
(the "Final Rule") claiming authority to regulate laboratory
developed tests (LDTs). LDTs are laboratory services that are
developed, validated and performed in-house by pathologists and
other laboratory professionals to provide patients timely access to
high-quality laboratory services. ASCP and four other medical
specialty societies (hereafter referred to as "the Amici Group," or
"the Group")—representing the largest collection of pathology and
laboratory organizations submitting an amicus brief urging the
court to overturn FDA's misguided LDT oversight scheme—are united
in support of the lawsuits filed by both the American Clinical
Laboratory Association (ACLA) and the Association of Molecular
Pathology (AMP). The two lawsuits were recently consolidated into a
single lawsuit to be heard in the U.S. District Court for the
Eastern District of Texas.
"ASCP has heard loud and clear from our
members that they are very concerned that the Final Rule will
undermine their ability to provide appropriate care for their
patients," ASCP President Gregory N.
Sossaman, MD, MASCP.
In joining with other key stakeholders on the amicus, ASCP
President Gregory N. Sossaman, MD,
MASCP, said, "ASCP has heard loud and clear from our members that
they are very concerned that the Final Rule will undermine their
ability to provide appropriate care for their patients. FDA's
approach to oversight is too slow, cumbersome, and expensive to
allow clinical laboratories to continue providing these critical
diagnostic services. FDA's flawed rule will massively scale back
what LDTs services patients will be able to access, including when
no commercial diagnostic is available. Given ASCP's dedication to
ensuring quality care, submitting this amicus brief is essential to
our mission of caring for patients." LDTs are frequently developed
for conditions or diseases for which no commercial test exists
and/or when existing commercial tests do not meet patient clinical
needs.
In submitting its amicus brief, ASCP and its partners concur
with plaintiffs ACLA and AMP that the FDA does not have the
authority to regulate laboratory developed tests. The Amici Group
argues that the Final Rule has already had "serious detrimental
effects on the clinical laboratories that develop and perform these
tests, and, ultimately, on the provision of care to patients who
rely on these testing services for prompt diagnosis and
treatment."
In the brief, the Amici Group rejects FDA's position that
clinical laboratories offering LDT services are violating federal
law, citing the Clinical Laboratory Improvement Amendments (CLIA),
which specifically outline the federal legal requirements clinical
laboratories must satisfy to perform testing services that are not
approved by FDA. The Group argues that FDA's enforcement
discretion policy of allowing certain CLIA-certified laboratories
to continue offering a limited subset of LDT services is so narrow
that it fails to achieve its stated purpose of ensuring patient
access to the laboratory services they need. Additionally, FDA's
Final Rule infringes upon the practice of medicine by experienced,
educated, and dedicated medical professionals.
Joining the ASCP in submitting this amicus brief are the
American Association of Bioanalysts, the American Society for
Microbiology, the Association for Diagnostics & Laboratory
Medicine, and the Infectious Disease Society of America.
About ASCP
Founded in 1922 in Chicago, ASCP
is a medical professional society with more than 100,000 member
board-certified anatomic and clinical pathologists, pathology
residents and fellows, laboratory professionals, and students. ASCP
provides excellence in education, certification, and advocacy on
behalf of patients, pathologists, and laboratory professionals. To
learn more, visit http://www.ascp.org. Follow us on Twitter at
http://www.twitter.com/ascp_chicago and connect with us on Facebook
at http://www.facebook.com/ASCP.Chicago.
Media Contact
Susan Montgomery, ASCP, (312)
541-4754, susan.montgomery@gmail.com, www.ascp.org
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SOURCE ASCP