The House Appropriations Committee issued five recommendations toward fiscal year 2025 that could affect the business of clinical laboratory testing and biomarker analysis.
First, the committee directed the U.S. Food and Drug Administration (FDA) to suspend its efforts to implement its final rule on laboratory developed test (LDT) regulations. The committee suggested that the FDA instead continue working with Congress to modernize the regulatory approach to LDTs, as stated in the 118 report on the FY25 Labor, Health and Human Services, Education, and Related Agencies Appropriations Act.
"The FDA’s final rule on LDTs puts forth a proposed regulatory framework that is a significant shift in the way LDTs are regulated and changes expectations for patients, doctors, and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988 at the risk of greatly altering the United States’ laboratory testing infrastructure and reducing patient access to information that informs their healthcare decision making," the House Appropriations Committee stated in its report.
The American Clinical Laboratory Association (ACLA) filed a lawsuit in June demanding that a court decide the rule should be set aside and vacated. Until further notice, however, Stage 1 of FDA LDT enforcement is set to begin May 6, 2025, with foundational compliance such as medical device reporting requirements, corrections and removals reporting, and quality systems. However, the FDA in its final rulemaking designated enforcement discretion policies for the following:
- Currently marketed IVDs offered as LDTs in consideration of concerns that expecting compliance with full quality system and premarket review requirements for such IVDs could lead to the loss of access to safe and effective IVDs on which patients currently rely.
- LDTs manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system in consideration of concerns that expecting full compliance with FDA requirements could lead to loss of access to such LDTs for which laboratories cannot recoup the costs of compliance.
- LDTs that are approved by the New York State Department of Health's Clinical Laboratory Evaluation Program (NYS CLEP) -- but only approved versions.
The FDA published an LDT compliance guide for small entities in June.
In the second House Appropriations Committee recommendation -- this one regarding over-the-counter (OTC) diagnostic tests -- the committee requested a briefing from the FDA on efforts to expand access to OTC diagnostic tests. The committee also requested an update on the pipeline for OTC diagnostic tests, with special attention to products that address infections for which there is no OTC diagnostic currently authorized. The committee noted OTC diagnostic tests that would improve accessibility for Americans, encourage more frequent testing of common infections, and provide an overall benefit to public health.
In vitro diagnostic (IVD) tests that have been traditionally performed in medical laboratories are increasingly being performed outside of labs. These tests are essentially untethered from their usual data collection and reporting systems, the FDA acknowledged earlier this year in a Diagnostic Data Program FDA briefing.
"As the availability of 'rapid tests' administered at [point of care] POC and sold [over the counter] OTC dramatically increased between late 2020-2022, the volume of testing increased rapidly while the percentage of diagnostic data being collected and reported dropped dramatically," the FDA briefing stated.
"Without the ability to capture, analyze, and utilize high quality data from non-lab-based tests, all stakeholders as well as patients and the general public will not be able to maximally benefit from more accessible testing," the FDA said. "Ensuring the quality and performance of tests, as well as the ability to protect patient privacy and security, will be crucial features of the ecosystem as it expands." Furthermore, "It will be critical that these non-lab-based data streams are harmonized and aggregated with lab-based data streams for similar diagnostic tests."
The FDA said in the briefing that it anticipates a broad expansion of software integration with IVDs will accelerate moving forward. Additionally, the FDA contracted with Safe Health Systems (SAFE) to lead its Open Connected Diagnostics initiative. This initiative is designed to accelerate implementation and adoption of connected diagnostics capabilities for use with digital health platforms as part of clinical workflows. Ultimately, the Open Connected Diagnostics initiative aims to establish interoperable connections between point of need (PoN) diagnostic test data silos.
Third, the House Appropriations Committee is concerned about the FDA’s failure to issue final regulations relating to the protection of human subjects, including parts 50 and 56 of title 21, Code of Federal Regulations, with the latest regulations of the Department of Health and Human Services relating to the inclusion of pregnant women as subjects in clinical research, as required by the 21st Century Cures Act.
"Despite 90 percent of pregnant women taking prescription medication during their pregnancy, 70 percent of medications approved by the FDA have no human pregnancy data, and 98 percent have insufficient data to determine the risk to the infant, leaving both the mother and infant at risk to adverse health events," the committee noted.
Continuing the topic of potential adverse drug events, the committee commended the FDA’s initiatives to increase the number of women and minorities in clinical trials to represent their unique health needs, gather safety and efficacy information to inform proper product labeling, and prevent adverse drug events (ADEs), which are twice as high for women. The committee also noted a forthcoming FDA report that will examine past drug approvals with identified pharmacogenomic safety issues.
Finally, the committee urged the FDA to provide guidance on the development of early disease clinical trial tools, including early-stage biomarkers and clinical endpoints. Qualified biomarkers have the potential to provide valuable information that may reduce uncertainty in regulatory decisions during drug development, the FDA noted in another briefing. In May, the FDA announced the implementation of a qualification search database to view the status of biomarker submissions.
The House Appropriations Committee approved the FY 2025 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act July 10 with vote of 29 to 26.
