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.

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