Health subcommittee praises DeGette bill to reform diagnostic testing

Washington, D.C. - Today, the U.S. House Committee on Energy and Commerce’s Subcommittee on Health held a hearing in which members questioned leading experts and medical professionals on diagnostic testing. This hearing was called in response to the Food and Drug Administration’s (FDA) proposed rule to regulate lab-developed tests (LDT).

During the hearing, both members and witnesses called for the House to consider the Verifying Accurate, Leading-edge, IVCT Development (VALID) Act. This legislation would overhaul the FDA’s approach to regulating in vitro clinical tests (IVCTs), including LDTs, and ensure uniform standards in clinical lab diagnostic testing.

Rep. Diana DeGette (D-CO), a member of the Energy & Commerce Committee and co-lead of the VALID Act with Rep. Larry Bucshon, M.D. (R-IN), released the following statement:

“The importance of passing the bipartisan VALID Act was thoroughly highlighted today,” Rep. DeGette said. “This hearing affirmed what I've long believed: our bill is the answer to streamline and improve how we regulate clinical lab diagnostics. Accurate diagnostics are crucial for patient care, and by moving forward with the VALID Act, we can help ensure every health decision is made with confidence.”

The witnesses and members agreed the VALID Act would be a better, more pertinent alternative to the FDA’s rule. Several key moments from the hearing include:

• “I do think there is good support, solid support for the VALID Act, and most frankly, I think that Congress needs to be pursuing that,” said Rep. Anna Eshoo (D-CA), ranking member of the Subcommittee on Health.
• “We also support the VALID Act and feel that inaction would be the worst outcome,” said Dr. Jeff Allen, President and CEO of Friends of Cancer Research.
• “[The VALID Act] is the right type of legislative effort that would create diagnostic specific framework,” said Susan Van Meter, President of the American Clinical Laboratory Association.
• In one instance, Rep. Diana Harshbarger (R-TN) asked, “Who wants to give the FDA more authority? I don’t as a pharmacist.” Dr. Donald S. Karcher, President of the College of American Pathologists responded, “It does, but we believe the VALID Act makes that authority very flexible and allows laboratories to continue to develop these lifesaving tests.”

Watch the full subcommittee hearing here. Watch Rep. DeGette’s question line here.

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