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- CAP Asks White House to Target FDA Oversight of LDTs on Highest Risk Tests
Leaders from the CAP met with officials from the White House Office for Management and Budget on April 18 to discuss our grave concerns with the Food and Drug Administration (FDA) proposed rulemaking on the oversight of laboratory-developed tests (LDTs). The proposed rule was under White House review and the CAP advocated for practical ways LDT oversight could be conducted more effectively.
CAP President Donald Karcher, MD, FCAP; Council on Government and Professional Affairs (CGPA) Chair Joe Saad, MD, FCAP; and CGPA Vice-Chair Diana Cardona, MD, FCAP, spoke with the White House officials. They said that the proposed rule, as written, would significantly burden clinical laboratories, making it very difficult and unacceptably costly for these laboratories to continue to develop much-needed and innovative LDTs, resulting in patients being deprived of these life-saving tests.
Instead, the CAP advocated for a better approach with a regulatory framework that focuses the FDA’s resources mostly on the highest-risk LDTs and provides significant flexibility in their oversight of lower-risk LDTs to preserve quality, patient safety, innovation, and patient access.
Read the CAP’s comments that followed the meeting and were sent to the Office for Management and Budget on April 19.
The CAP believes that the White House is close to concluding its review of the FDA proposal. Once the final regulation is released, the CAP will provide its members with an initial analysis of regulation and how it will impact laboratories.