Lab Developed Test (LDT) Rule : Lab Industry Sues to Stop FDA’s New Regulation

Lab Developed Test (LDT) Rule enforcement is at the center of a lawsuit filed by the American Clinical Laboratory Association (ACLA) against the Food and Drug Administration (FDA). The ACLA argues that the FDA lacks the authority to impose stricter standards on LDTs, contending that these tests should not be regulated as medical devices by the agency. This legal action was taken in the U.S. District Court for the Eastern District of Texas, with the ACLA seeking to have the FDA’s final rule on LDTs vacated.

The FDA implemented the controversial rule in April, aiming to tighten oversight of LDTs to enhance their safety and accuracy. The agency claims that the risks associated with LDTs, a category of in vitro diagnostics designed and used within a single laboratory, have increased significantly since the FDA’s initial, more lenient regulatory approach nearly 50 years ago.

The ACLA contends that LDTs are professional services performed by laboratory professionals, not medical devices. According to the ACLA, Congress did not grant the FDA the authority to regulate LDTs as medical devices. Instead, LDTs are federally regulated by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA). The ACLA, whose members include prominent industry players such as Labcorp, Quest Diagnostics, and multiple test developers, accused the FDA of regulatory overreach, asserting that the agency’s actions violate the Administrative Procedure Act.

“The statutory definition of device does not extend to laboratory developed tests, which are professional services,” ACLA President Susan Van Meter stated in a Wednesday briefing. Van Meter emphasized that the FDA’s decision to use its enforcement authority to regulate LDTs moving forward suggests that the agency does not view the existing system as posing an immediate safety issue.

In contrast, the FDA argues that the landscape for LDTs has evolved, with many LDTs now being produced by laboratory corporations that market them nationwide and conduct tests on a large scale. These tests are often used to diagnose serious medical conditions such as heart disease, Alzheimer’s disease, and cancer risk prediction. Under the FDA’s new policy, LDTs will be subject to a rigorous premarket review process, similar to in vitro diagnostics manufactured outside of laboratories. This process requires manufacturers to register the tests with the FDA and report adverse events.

Despite these new regulations, LDTs already on the market and new tests addressing unmet needs will remain under the former regulatory framework. Additionally, LDTs approved by the New York State Department of Health’s Clinical Laboratory Evaluation Program are excluded from the premarket review requirements.

The ACLA believes that applying the medical device framework to LDTs is inappropriate. Van Meter highlighted the lack of scientific evidence from the FDA to justify its regulatory actions, stating, “[The] FDA has provided no real scientific evidence demonstrating a patient safety or public health justification for its action.”

Mahnu Davar, an attorney with Arnold & Porter specializing in healthcare issues, noted that a legal challenge to the FDA’s final rule was expected. In the lawsuit, the ACLA argued that the FDA lacks new statutory authority to change the regulatory framework that has been in place for decades, especially since recent legislative proposals that would have granted the agency new powers to regulate LDTs were not enacted. The ACLA had supported the Verifying Accurate, Leading-edge IVCT Development (VALID) Act in Congress, but the legislation stalled.

“We will be watching the docket closely to see how [the] FDA responds and how the litigation unfolds,” Davar wrote in an email to MedTech Dive. “In the interim, companies will be assessing whether or not to invest in building the systems and compliance programs needed to prepare for the first years of the phase-in proposal.”

Under the final rule, the FDA’s old enforcement discretion policy will be phased out over four years. This transition period is intended to allow laboratories time to adapt to the new regulatory requirements. The outcome of the lawsuit and the FDA’s response will be closely monitored by industry stakeholders, as it will have significant implications for the regulation and future development of LDTs.

In summary, the ACLA’s lawsuit against the FDA highlights the ongoing debate over the appropriate regulatory framework for LDTs. The legal challenge seeks to overturn the FDA’s new rule, arguing that the agency has overstepped its authority. The resolution of this case will be critical in determining the future oversight and regulation of LDTs, impacting laboratories, manufacturers, and patients relying on these essential diagnostic tools.