AHA has urged lawmakers to consider certain changes to the Verifying Accurate Leading-Edge IVCT Development (VALID) Act, legislation that would modify the regulatory framework for laboratory developed tests.
The VALID Act is included in the Food and Drug Administration Safety and Landmark Advancements Act (S.4348), which the Senate Committee on Health, Education, Labor, and Pensions Committee will markup on Wednesday.
“The AHA is concerned that, if enacted in its current form, the VALID Act could lead to a loss of patient access to many critical tests and could dramatically slow down advances in hospital and health system laboratory medicine,” AHA said in a letter to leaders of the Senate HELP Committee. “Given the value of these tests to caregivers and patients, any framework for regulatory oversight of LDTs must ensure that the technological and clinical innovation that is essential to their development remains unrestricted; that quality and reliability are maintained at the highest levels possible; and that they continue to be widely accessible to patients. In contrast, we believe the provisions in the VALID Act could cause confusion and delays that could hinder the achievement of these goals and possibly prevent hospital and health system laboratories from continuing to develop cutting-edge LDTs in response to immediate clinical care needs.”