The Flawed Rule

When the FDA released its Final Rule on Laboratory Developed Tests (LDTs) earlier in 2024, ASCP and its members responded in force. Since the first mention of the proposed rule, ASCP has adamantly opposed it, and has supported efforts to override the rule.

In October, ASCP filed an amicus curiae brief seeking to overturn the FDA’s Final Rule. This brief was filed in collaboration with four other medical specialty societies to urge the court to overturn what we see as the FDA’s misguided LDT oversight scheme. By joining with these other societies – the American Association of Bioanalysts, the American Society for Microbiology, the Association for Diagnostics & Laboratory Medicine, and the Infectious Disease Society of America – we are further bolstering lawsuits filed by both the American Clinical Laboratory Association (ACLA) and the Association of Molecular Pathology (AMP). And, more importantly, we are listening to our members and supporting their concerns about the Final Rule undermining their ability to provide the right care at the right time for their patients. As ASCP President Gregory Sossaman stated in a recent article, “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.”

More recently, we have continued our efforts to overturn the rule, reaching out to the Trump transition team to urge the incoming administration to rescind the Final Rule, noting that the previous Trump Administration ruled that the FDA should not regulate LDTs.

Sossaman expressed optimism that by rescinding the FDA’s Final Rule, President Trump’s administration would send a clear message to the FDA and Congress that LDTs are already regulated effectively – ensuring adaptability without unnecessary bureaucracy – under the Clinical Laboratory Improvement Amendments of 1988. To uphold the highest standards of patient care, it is essential that we support accredited clinical laboratories in developing and offering innovative, cost-effective, and quality laboratory services, rather than hindering their efforts.

2024 has been a year of considerable and, in some cases, extensive changes for the laboratory. As we look forward to 2025, it is with a clear vision of the laboratory as central to high-quality patient care. If the FDA’s Final Rule isn’t overturned, continuing to provide critical diagnostic services will become a hindrance to patient care, creating a slow, cumbersome, and expensive process. In the year ahead we will continue to focus advocacy efforts on rescinding this rule and ensuring that patient care remains at the forefront of not only pathology and laboratory medicine, but for healthcare overall.