Advocacy - Lab Advocate
The Senate Appropriations Subcommittee on Labor, Health and Human Services, and Related Agencies included language in its FY 2025 budget bill directing the CDC to secure funding for improved pediatric reference intervals (PRIs) in its FY 2026 budget. This follows a concerted effort by ADLM, which has been leading a coalition of 42 professional societies, clinical laboratories, and manufacturers advocating for this cause.
On the House side, Rep. John Joyce, co-chair of the bipartisan Children's Health Caucus, played a pivotal role in ensuring that similar language was included in the House's FY 2025 budget bill. Rep. Joyce has been a strong advocate for enhancing pediatric healthcare, emphasizing the necessity of PRIs tailored to children’s unique physiological needs. His leadership in the Children’s Health Caucus underscores a broader bipartisan commitment to improving diagnostic and treatment protocols for pediatric patients.
Additionally, the House FDA appropriations bill contains language directing the FDA not to advance its Laboratory Developed Tests (LDT) final rule. Although report language does not carry the force of law, it indicates congressional support for ADLM’s position:
Laboratory Developed Tests.-The FDA's final rule on Laboratory Developed Tests (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 Committee directs the FDA to suspend its efforts to implement the rule and continue working with Congress to modernize the regulatory approach for LDTs.