Lawmakers have told the Food and Drug Administration to suspend efforts to implement its final rule on laboratory developed tests (LDTs).
The House Appropriations Committee made the request Wednesday in legislation about funding the FDA and other federal agencies will receive in its 2025 financial year. Committee members backed the appropriations bill by a 29-26 vote.
As well as agreeing to provide the FDA with $3.5 billion in direct appropriations, the lawmakers shared advice on how the agency should use the money. The recommendations include a call to suspend work on the final rule and partner with Congress to modernize the regulation of LDTs.
The recommendation reflects a belief the final rule carries “the risk of greatly altering the United States’ laboratory testing infrastructure and reducing patient access to information that informs their healthcare decision making.” The lawmakers said the rule proposes a framework that is a significant shift in the way LDTs are regulated and changes expectations for the first time since 1988.
The FDA had previously taken an enforcement discretion approach with LDTs, or tests designed and used within a single laboratory. In April, the agency finalized a rule clarifying that LDTs would be regulated as medical devices, similar to other in-vitro diagnostics, which is a stricter review process.
The FDA proposed and finalized its LDT rule after Congress repeatedly failed to pass legislation to clarify the regulatory framework for the tests. Critics have accused the FDA of exceeding its authority, and the American Clinical Laboratory Association sued to have the rule vacated.
