Pew and 7 Patient Health Organizations Call on Senators to Strengthen Oversight of Clinical Tests

The Pew Charitable Trusts and seven patient health organizations wrote to the leaders of the Senate Health, Education, Labor, and Pensions Committee on May 22 urging its members to incorporate key changes into the draft reauthorization of the Food and Drug Administration’s medical product user fees, which also includes provisions to overhaul diagnostics regulation.

In addition to the reauthorization language, the draft released May 17 incorporates the language of a separate bill known as the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would bring all in vitro diagnostic tests—used to analyze blood, tissue, and other human samples—under one risk-based review system. Pew and the coalition of health groups expressed serious concerns that certain provisions in the VALID discussion draft would likely impose a significant burden on FDA’s ability to ensure that lab-developed tests are safe and effective.