Pew Urges Senators to Strengthen Clinical Tests Bill to Better Protect Patients

The Pew Charitable Trusts wrote to the leaders of the Senate Health, Education, Labor, and Pensions Committee on May 21 urging them 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.

But Pew experts cautioned in their analysis that several provisions, if not structured appropriately, could undermine FDA’s ability to oversee the diverse and rapidly growing diagnostics market. To strengthen public health protections, Pew urges the committee to consider several updates to the bill language. Lawmakers should:

• Narrow the categories of tests that are exempt from premarket review to ensure that high-risk tests are subject to appropriate oversight.
• Require that tests introduced through the new technology certification review pathwaymeet applicable standards for validity and quality.
• Bolster FDA’s postmarket authorities to allow the agency to know how tests are performing and to act to protect public health.
• Provide FDA with adequate resources to effectively implement regulatory reforms and oversee the diagnostic test market.