The FDA has been instructed by lawmakers to halt the implementation of its final regulation related to laboratory-developed tests (LDTs). The proposal for funding that the FDA and other government agencies will receive in their 2025 fiscal year was made by the House Appropriations Committee in legislation. By a vote of 29 to 26, committee members supported the funding measure.
The legislators allocated $3.5 billion in direct funding to the FDA and offered suggestions on how the agency should spend the funds. One of the recommendations is to put a hold on the final rule’s development and work with Congress to update the laws governing LDTs.
According to the suggestion, there is “a risk that the final rule will significantly alter the laboratory testing infrastructure in the United States and reduce patient access to information that informs their healthcare decision-making.” The legislators noted that the regulation modifies expectations for the first time since 1988 and offers a framework that represents a substantial change in the way LDTs are governed.
Previously, when it came to LDTs—tests created and utilized only in one laboratory—the FDA had adopted an enforcement discretionary approach. However, in April, the government issued a regulation clarifying that LDTs will be subject to a tougher review procedure and regulated as medical devices, just like other in-vitro diagnostics.
Following many failed attempts by Congress to enact legislation to define the regulatory framework for these tests, the FDA drafted and published its LDT regulation. The American Clinical Laboratory Association filed a lawsuit to get the regulation revoked after critics accused the FDA of overstepping its jurisdiction.
