ACLA Statement on Updated VALID Act Introduced as Part of Senate FDA User Fee Package
Washington, D.C. – In response to the Senate Committee on Health, Education, Labor and Pensions’ (HELP) release of a bipartisan, updated version of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, as part of a legislative package that would renew various FDA user fee programs, ACLA President, Susan Van Meter, issued the following statement:
“We commend Senate HELP Committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) for their leadership and commitment to a bipartisan legislative process. Today’s release of the updated VALID Act, which aims to establish a diagnostics-specific regulatory framework for all diagnostic tests, represents a pivotal moment in the multi-year effort on diagnostic regulatory reform.
ACLA and our members are moving swiftly to review the discussion draft and will submit comments to the HELP Committee outlining our position on the policies included in the updated legislation. ACLA remains focused on ensuring that the new regulatory paradigm would fully recognize the critical role of clinical laboratories in public health and patient health, preserve and foster innovation in clinical laboratories, while maintaining access to empower providers and patients in health care decisions.
ACLA members are high-complexity, CLIA-certified and CAP-accredited clinical laboratories and leaders on the forefront of medical innovation across virtually all areas of patient care and public health. Through the development and validation of laboratory developed tests (LDTs), ACLA members address unmet medical needs, aid diagnoses and guide treatment and prevention, which, taken together, reduce the cost and increase the quality of care available to patients. While laboratories have been driving innovation for decades across common and rare diseases alike, the pandemic has made the public acutely aware of the value of clinical laboratories and laboratory tests in facilitating informed and quality health care decisions. Laboratories need clarity and certainty in the regulatory environment to respond to public health emergencies, encourage innovation and develop the next generation of breakthrough technologies.”
ACLA’s comments on the VALID Act, as introduced in the U.S. House of Representatives in 2021, are available here.
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The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.
