The U.S. House Appropriations Committee has requested that the Food and Drug Administration (FDA) halt its efforts to finalize regulations on laboratory developed tests (LDTs). This request was made in legislative proposals related to the funding of the FDA and other federal bodies for the fiscal year 2023. The committee, which passed the appropriations bill with a close vote of 29-26, also agreed to allocate $3.5 billion in direct appropriations to the FDA. Included in their funding recommendation is an advisement for the FDA to suspend their work on the final ruling regarding the regulation of LDTs and to collaborate with Congress to modernize these regulations.
The push to pause the implementation of the new rule comes amid concerns from lawmakers. They argue that the proposed rules could significantly transform the United States’ laboratory testing landscape, potentially restricting patient access to critical information that aids in healthcare decision-making. This represents a significant change from current practices, having been the first major shift in the regulation of LDTs since 1988.
Historically, the FDA had adopted a hands-off enforcement discretion approach towards LDTs, which are diagnostic tests that are both developed and used within a single laboratory. However, in April, the FDA shifted its stance by finalizing a rule that classified LDTs as medical devices. This classification aligns them with other in-vitro diagnostics and subjects them to a more stringent review process.
The decision to regulate LDTs through tighter controls came after Congress had failed several times to pass legislation specifying the regulatory framework for these tests. The FDA’s move to finalize the rule autonomously has drawn criticism and accusations of overstepping its regulatory authority. In response to this, the American Clinical Laboratory Association has initiated a lawsuit seeking to overturn the rule.
The committee’s recommendation to suspend the rule and engage with Congress indicates a preference for a more collaborative approach to addressing the complexities of LDT regulation, spotlighting the ongoing debate between regulatory oversight and innovation in healthcare diagnostics.
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