House Committee Asks FDA to Suspend Rule on Lab-Developed Tests

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Lawmakers have asked the Food and Drug Administration to pause efforts to implement its final rule on laboratory-developed tests (LDTs).

The House Budget Committee made the request Wednesday in a bill to fund the FDA and other federal agencies in fiscal year 2025. Committee members supported the budget bill by a vote of 29 to 26.

In addition to approving $3.5 billion in direct funding to the FDA, lawmakers also made recommendations on how the agency should use the money. Among the recommendations is a call to pause work on the final rule and work with Congress to modernize regulation of LDTs.

The recommendation reflects the belief that the final rule “risks significantly altering the United States laboratory testing infrastructure and limiting patients’ access to information that influences their medical decisions.” The lawmakers said the rule proposes a framework that represents a significant shift in the way LDTs ​​are regulated and changes expectations for the first time since 1988.

The FDA had previously pursued enforcement discretion with LDTs, tests developed and used in a single laboratory. In April, the agency adopted a rule clarifying that LDTs ​​would be regulated as medical devices, similar to other in vitro diagnostics, subject to a more rigorous review process.

The FDA proposed and passed its LDT rule after Congress repeatedly failed Legislation to clarify the regulatory framework for the tests. Critics will have accused the FDA for exceeding its authority and the American Clinical Laboratory Association sued to have the rule repealed.