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- CAP President Meets with Congress and Seeks Relief from Burdens of FDA LDT Rule
On June 4, CAP President Donald Karcher, MD, FCAP met with multiple members of the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor and Pensions. Following the release of the overly burdensome laboratory-developed tests (LDT) regulation by the US Food and Drug Administration (FDA), the CAP has sought to engage with congressional leaders to advocate for legislative solutions that reduce regulatory burdens on laboratories and allow for continued innovation of tests.
Dr. Karcher discussed the CAP’s position on the Verifying Accurate Leading-edge IVCT Development (VALID) Act with the legislative staff of top leaders of committees with jurisdiction over the FDA. He advocated that the legislation moves in a positive direction, away from the overreach of the FDA’s LDT final rule, establishing a reasonable regulatory framework that ensures the quality of LDTs for patients and the public regarding while not stifling innovation.
He encouraged members of Congress to consider the negative implications the FDA’s strict regulation will have on pathologists and laboratories meeting the needs of a diverse patient population across the United States and how a congressional solution is the necessary path forward.