The LDT Final Rule is Officially Dead: FDA Has No Jurisdiction

Patients and Pathology Win Latest Battle 

May 30th marked an important date in FDA’s effort to claim oversight of laboratory developed tests (LDTs). This was the deadline for FDA to appeal U.S. District Court Judge Sean D. Jordan’s decision to vacate the agency’s Final Rule seeking to regulate LDTs (see the infographic below outlining some of the key dates related to LDT oversight). And by the end of that day, we learned that the federal government declined to appeal the judge’s decision. This victory for patient care marks the latest milestone in a 40-year saga regarding government responsibility to regulate LDTs. 

FDA began asserting jurisdiction over LDTs in the early 1990s and started seriously considering taking regulatory action in the early 2000s. ASCP recognized that these were significant developments and began implementing patient-centric policy and advocacy initiatives to ensure that high-quality patient care considerations were at the forefront of the debate. These efforts have been a defining element of our advocacy agenda for well over a decade, and they were the reasons that ASCP, guided by the expertise of noted attorney Jane Pine Wood, joined with four other patient-focused medical specialty societies to file an amicus curiae brief in the lawsuit opposing FDA’s oversight scheme. 

ASCP is extremely pleased that Judge Jordon’s ruling means that FDA lacks the statutory authority to regulate LDTs. ASCP President Gregory Sossaman, MD, MASCP, said after Jordon announced his decision, “This is an important victory for quality patient care.” Under FDA’s oversight plan, most laboratories would have faced significant barriers to providing these critical services, ultimately restricting patient access to vital testing and care.  

Not surprisingly, the court victory raises a question about LDT oversight moving forward. ASCP and the vast majority of organizations representing the laboratory community believe that LDTs should be regulated by CMS under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) framework. The district court addressed this question, stating that “Congress considered the unique regulatory issues raised by clinical laboratories and the tests they develop and perform. It addressed those issues through the comprehensive but distinct statutory regime of CLIA, not through the FDCA [Food, Drug, and Cosmetics Act].” Meaning that the authority to regulate LDTs belongs to CMS, not FDA. 

When CMS adopted new regulations for CLIA in early 2003, it set in place new performance requirements a laboratory must satisfy when it “introduces a test system not subject to FDA clearance or approval (including “methods developed in-house…[emphasis added]).” These requirements are still in place, and they serve as the foundation for CLIA’s analytical validity requirement, among others, and can  encompass any other “performance characteristic required for test performance.” 

With the court’s ruling about who has authority over LDTs settled, ASCP will be working with its advocacy partners to lend expertise to CMS in its oversight of LDTs. We will also continue our efforts to prevent any legislation similar to the VALID Act from stymieing clinical laboratories to meet the needs of their patients.