Dive Brief:
- The Association for Molecular Pathology (AMP) has sued the Food and Drug Administration to block the agency from enforcing a final rule that expands its regulatory authority over laboratory developed tests (LDTs).
- The lawsuit, filed last week in U.S. District Court for the Southern District of Texas, argues the rule should be set aside because the FDA lacks the authority to regulate LDTs.
- AMP — which represents pathologists, doctoral scientists and other laboratory professionals — said it fears the new policy will jeopardize test innovation and patient access to essential medical care, force numerous small labs to close and raise healthcare costs. “It is imperative that this court act to prevent the catastrophic consequences that FDA’s final rule will unleash,” the complaint states.
Dive Insight:
AMP is the second laboratory trade group to take on the LDT rule in court. The American Clinical Laboratory Association (ACLA) filed a lawsuit challenging the FDA’s plan just weeks after the regulation was published on May 6.
Like ACLA, AMP maintains the agency does not have congressional authority to regulate LDTs as devices. The rule, which AMP called a “power grab,” treats LDTs as medical devices, subject to the same level of oversight. Instead, Congress delegated authority to the Centers for Medicare and Medicaid Services (CMS) to regulate the tests as lab services, both associations assert.
AMP’s complaint also alleges the rule interferes with an exemption in the federal Food, Drug, and Cosmetic Act that prohibits the FDA from regulating the practice of medicine.
“The FDA rule threatens the ability of professionals in clinical laboratories, including many academic medical centers, reference laboratories and community health systems across the country, to create, adapt and modify LDTs to meet patients’ needs,” AMP said in a statement.
The FDA has said that the risks associated with LDTs, which are used to diagnose a broad range of medical conditions, have increased as the tests have become more complex, necessitating stricter oversight to protect patient safety. The agency’s former policy of using enforcement discretion to regulate LDTs will be phased out over four years.
AMP argues the best way to ensure tests are reliable and their results are applied correctly is to modernize the Clinical Laboratory Improvement Amendments (CLIA) administered by the CMS.
The group’s complaint paints a grim picture of the consequences of expanded FDA oversight.
“Many laboratories and laboratory professionals will be forced to stop providing vulnerable patients with cutting-edge medical care and will abandon ongoing efforts to develop additional LDTs that could timely diagnose fast moving diseases (e.g., cancers) and mitigate emerging public-health threats (e.g., the next pandemic),” AMP said in the lawsuit.
AMP and University of Texas pathologist Michael Laposata filed the suit, which also names FDA Commissioner Robert Califf and Health and Human Services Secretary Xavier Becerra as defendants.
As the new rule is implemented in stages, the FDA expects test makers to comply with medical device reporting, correction and removal reporting, and quality system requirements for complaint files starting May 6, 2025.
Compliance with registration, listing, labeling and investigational use requirements is expected by May 6, 2026, and premarket review requirements for high-risk in vitro diagnostics offered as LDTs are expected by Nov. 6, 2027.