Pew and 10 Patient Health Organizations Call for Stronger Federal Oversight of Clinical Tests

The Pew Charitable Trusts and 10 patient health groups sent a letter to Department of Health and Human Services Secretary Xavier Becerra on April 5 applauding the administration’s engagement on diagnostics reform. Additionally, the letter urges the department to continue working with Congress to pursue improved oversight of medical blood tests and similar products through the Verifying Accurate Leading-edge IVCT Development (VALID) Act. The bill, which was introduced in 2021, seeks to bring all in vitro diagnostic tests—including those developed and used in individual laboratories (abbreviated as LDTs)—under one risk-based regulatory system. Under current policy, the Food and Drug Administration—which is part of Secretary Becerra’s department—typically does not review LDTs’ accuracy or performance, and businesses running these tests do not have to disclose cases when their products harm patients. This gap in FDA oversight poses unnecessary risks for both patients and public health and has allowed unreliable tests to reach the market, leading to incorrect diagnoses and treatment.

In addition to Pew, the letter is signed by the American Society of Clinical Oncology, Cancer Support Community, Center for Science in the Public Interest, FORCE: Facing Our Risk of Cancer Empowered, Lymphoma Research Foundation, Muscular Dystrophy Association, National Center for Health Research, National Consumers League, Public Interest Research Group, and Triage Cancer.