Broad Coalition Urges Congress to Include Diagnostics Reforms When Reauthorizing FDA User Fee Programs

The Pew Charitable Trusts and 45 organizations, including medical test manufacturers, laboratories, and groups representing physicians, health care providers, patients, and consumers, are urging Congress to incorporate key diagnostic reform provisions in legislation to   reauthorize the Food and Drug Administration’s medical product user fees. On July 20, the group wrote to leaders of the Senate Health, Education, Labor, and Pensions Committee and the House Committee on Energy and Commerce, making the case that the provisions, now in the Senate version, should remain in the final measure.

The Senate HELP Committee approved the FDA Safety and Landmark Advancements Act  S. 4348, on June 14. The legislation, which is awaiting action by the full Senate, includes key provisions of a separate bill known as the Verifying Accurate Leading-edge IVCT Development (VALID) Act. That measure would bring all in vitro diagnostic tests—used to analyze blood, tissue, and other human samples—under one risk-based review system.