ASCP Files Amicus Brief Urging Court to Overturn FDA Final Rule on LDTs

ASCP has filed an amicus curiae brief in a lawsuit seeking to overturn the U.S. Food and Drug Administration (FDA) Final Rule claiming authority to regulate laboratory developed tests (LDTs). 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 FA's misguided LDT oversight scheme--have joined together to bolster the lawsuits filed by both the American Clinical Laboratory Association (ACLA) and the Association of Molecular Pathology (AMP). Besides ASCP, the American Association of Bioanalysts, the American Society for Microbiology, the Assocation for Diagnostics & Laboratory Medicine, and the Infectious Disease Society of America are united in their opposition to the FDA rule.  

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 FDA’s 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. This 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 focus on ensuring quality care, submitting this amicus brief is essential to our mission of caring for patients.”

In submitting the 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 perform these tests, and, ultimately, on the provision of medical 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 outlines federal legal requirement clinical laboratories must satisfy to provide testing services not approved by the FDA. The Group argues that FDA’s enforcement discretion policy 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 critical testing services. Additionally, FDA’s Final Rule infringes upon the practice of medicine by experienced, educated, and dedicated medical professionals.

Representing ASCP in developing the amicus brief is Jane Pine Wood, of McDonald Hopkins, an attorney well known for her work with the pathology and laboratory medicine community.

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