Laboratory-developed tests (“LDTs”) appear to be under FDA’s microscope once again. These tests, which include genetic tests, companion diagnostics, and genetic tests, are developed and performed by a laboratory and have been the source of years of strife between the laboratory industry and FDA. FDA has historically stated that it exercises enforcement discretion when it comes to LDTs. However, on June 2, Margaret Hamburg, commissioner of FDA, stated during an American Society of Clinical Oncology meeting that FDA is considering taking some sort of action with regard to its regulation of LDTs. That sentiment reflects FDA’s position from a June 17, 2010 Federal Register notice stating that more regulation of LDTs may be necessary due to FDA’s observations that the nature of LDTs was changing from “generally relatively simple, well-understood pathology tests” to tests that “are often used to assess high-risk but relatively common diseases and conditions and to inform critical treatment decisions and are often performed in geographically distant commercial laboratories instead of within the patient’s health care setting under the supervision of a patient’s pathologist and treating physician, or may be marketed directly to consumers.” A copy of that Federal Register notice is available here.
To complicate matters, the Food and Drug Administration Safety and Innovation Act (“FDASIA”), enacted last year, requires that FDA notify Congress with the details of any anticipated action at least 60 days before issuing any draft or final guidance on the regulation of LDTs. Not surprisingly, the laboratory industry strenuously opposes FDA regulation. As evidenced by a Citizen Petition submitted by the American Clinical Laboratory Association (“ACLA”) to FDA requesting that FDA confirm that LDTs are not devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”), ACLA argues that LDTs are beyond FDA’s jurisdiction because the Center for Medicare and Medicaid Services has authority to regulate LDTs under the Clinical Laboratory Improvements Amendments of 1988 (“CLIA”). FDA has addressed and denied such Citizen Petitions in the past.
As FDA may move forward with regulating LDTs as medical devices, members of the laboratory industry should be aware of the potential controversial change in FDA policy and should be prepared to comment on any proposed guidance or regulation that the agency may produce on LDT policy or regulation. Additionally, physicians and laboratories developing and using LDTs should be aware of whether their tests meet the recognized criteria of LDTs or whether their tests could qualify as medical devices subject to FDA regulation.