The House Appropriations Committee approved a measure on July 10 that requests the U.S. Food and Drug Administration suspend implementation of the final rule regarding laboratory-developed tests (LDTs).
The request was made as part of a full markup of the Fiscal Year 2025 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, which was approved by the committee with a vote of 29 to 26.
In the bill report, the committee directs the FDA to suspend implementation of the final rule, allowing more time for Congress to work with the agency to modernize the regulatory approach for LDTs. The committee explains that the proposed regulatory framework “is a significant shift in the way LDTs are regulated … since the Clinical Laboratory Improvement Amendments Act was passed in 1988.” It warns of the risk the rule poses to the U.S. laboratory testing infrastructure and patient access to essential information for health care decision-making.
In a July 23 advocacy update, the College of American Pathologists (CAP) affirmed its support of a delay, which gives Congress time to pass legislation that restricts the FDA and focuses full oversight on the highest-risk tests. In a July 9 briefing, CAP President Donald Karcher, M.D., and Joe Saad, M.D., president of the Surgical Pathologists of Dallas, discussed a stakeholder-approved, risk-based regulatory framework that provides oversight of LDTs while also allowing for innovation of new testing.
Sources:
https://docs.house.gov/meetings/AP/AP00/20240710/117503/HMKP-118-AP00-20240710-SD004.pdf
https://www.cap.org/advocacy/latest-news-and-practice-data/july-23-2024#story1
