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- CAP, Patient, and Health Industry Groups Urge Congress to Include VALID Act in FDA Bill
In a letter to Congress on July 20th, the CAP and nearly 50 organizations representing physicians, patient advocates, and health care industry have asked Congress to include the Verifying Accurate Leading-edge IVCT Development (VALID) Act’s in the FDA user fee reauthorization bill as key lawmakers negotiate a final version of the legislation.
Signatories on the letter to support the advancing the VALID Act as part of the pending FDA User Fee legislation included the American Society of Clinical Oncology (ASCO), American Cancer Society Cancer Action Network, BD (Beckton, Dickson and Co.), Bio-Rad Laboratories, Center for Science in the Public Interest, Cepheid, Friends of Cancer Research, Hologic, Muscular Dystrophy Association, Ovarian Cancer Research Alliance, Pew Charitable Trusts, and Roche Diagnostics.
The VALID Act is a bipartisan, bicameral bill that would create a new comprehensive regulatory framework for clinical laboratory tests that includes laboratory-developed tests (LDTs). Members of Congress in the House and Senate are currently trying to strike an agreement on the overall FDA user fee package. The Senate Committee on Health, Education, Labor, and Pensions (HELP) had included the VALID Act in its version of the FDA bill.
“As Congress finalizes a legislative package reauthorizing FDA’s user fee programs, it can also seize this truly unique opportunity to advance a flexible, risk-based regulatory system for all in vitro clinical tests,” the letter said. “We appreciate your continued support for meaningful diagnostics reform, and we remain committed to working with you and the committees to advance this legislation into law this year.”
Read the full letter to congressional leaders.