Pew Acknowledges Progress on Senate-Led Efforts to Advance Clinical Test Oversight Legislation

Lawmakers should continue to strengthen the bill with two key improvements

Progress on Advancing Clinical Test Oversight Legislation

The Pew Charitable Trusts wrote to the leaders of the Senate Health, Education, Labor, and Pensions Committee on June 8 expressing appreciation for their efforts to reform the regulation of clinical testing through S. 4348, the Food and Drug Administration Safety and Landmark Advancements  Act of 2022.

The crucial clinical testing reforms included in the legislation—which would strengthen FDA oversight of all tests and help prevent patients from harms posed by inaccurate results—are the product of years of collaboration led by the Senate and House sponsors of the Verifying Accurate Leading-edge IVCT Development (VALID) Act. While the VALID Act has improved considerably over the course of three sessions of Congress, Pew encouraged the committee to address two outstanding issues before advancing it to the full Senate:

  • Ensure that test importers comply with the same registration and reporting requirements as domestic test developers.
  • Provide FDA with the authority to make certain that tests for infectious diseases meet appropriate risk-based standards for validity and reliability.

Pew’s more detailed assessment of the legislation is also available online.