U.S. House to FDA: Nix LDT Rule Free

In May, the FDA issued a final rule for regulating laboratory-developed tests (LDT; see Cancer Discov 2024 Jun 25 [Epub]). But now, as part of its funding recommendations for fiscal year 2025, the U.S. House Appropriations Committee “directs the FDA to suspend its efforts to implement the rule and continue working with Congress to modernize the regulatory approach to LDTs.” Lawmakers believe that the proposed regulatory framework “is a significant shift in the way LDTs are regulated and changed expectations for patients, doctors, and laboratories … at the risk of greatly altering the laboratory testing infrastructure and reducing patient access to information that informs their healthcare decision making.” As for the appropriation, the committee called for an allocation of $3.50 billion, which would be added to $3.25 billion in user fees. The full House must approve the legislation and work with the U.S. Senate to determine the final appropriation. To read the legislation, see https://docs.house.gov/meetings/AP/AP00/20240710/117503/HMKP-118-AP00-20240710-SD004.pdf.