Pew and 10 patient health organizations call for stricter federal oversight of clinical trials
On April 5, the Pew Charitable Trusts and 10 patient health groups sent a letter to Department of Health and Human Services Secretary Xavier Becerra applauding the administration’s commitment to diagnostics reform. Additionally, the letter urges the department to continue working with Congress to improve 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, aims to consolidate all in vitro diagnostic tests, including those developed and used in individual laboratories (abbreviated LDT), under a single risk-based regulatory system. Under current policy, the Food and Drug Administration — part of Secretary Becerra’s department — generally does not review the accuracy or performance of LDTs, and companies that perform these tests do not have to disclose instances where their products harm patients. This gap in FDA oversight poses unnecessary risks to patients and public health and has allowed unreliable tests to reach the market, leading to incorrect diagnoses and treatments.
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 Consumer League, Public Interest Research Group and Triage Cancer.