The College of American Pathologists (CAP) responded to a request for information from Senate leadership regarding how to improve regulation of clinical tests in the United States.
Senator Bill Cassidy, M.D. (R-La.), ranking member of the Senate Health, Education, Labor, and Pensions Committee, initially requested this information from stakeholders on March 13.
“Clinical diagnostics play a critical role in our health care system, influencing nearly 70 percent of all health care decisions,” Cassidy wrote in a letter addressed to interested parties. “In the past, Congress has considered proposals to bring needed reforms to diagnostics regulation. These efforts have been unsuccessful and have resulted in missed opportunities to implement substantive updates to both regulatory frameworks.”
The April 10 response from the CAP answered Cassidy’s questions, outlined in his letter, concerning the U.S. Food and Drug Administration framework for diagnostics, as well as the Clinical Laboratory Improvement Amendments (CLIA) regulatory framework for laboratory-developed tests (LDTs).
The CAP expressed its opposition to the FDA proposed rule and recommended a patient-focused, tiered-risk approach to regulation, “with direct FDA regulatory oversight of only the highest-risk tests.” Additionally, the CAP opposes CLIA modernization, which would permit legislative changes to allow for LDT oversight. Such changes would place regulatory responsibility with the Centers for Medicare & Medicaid Services, which CAP explained “lacks the resources and expertise necessary to provide this oversight.”
As an alternative to the proposed FDA rulemaking, the CAP recommends passage of the Verifying Accurate Leading-edge In Vitro Clinical Tests (IVCTs) Development (VALID) Act (H.R. 2369). This legislation would require the FDA to regulate IVCTs and would utilize the tiered-risk approach.
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