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- Pathologists Hold Capitol Hill Briefing to Encourage Congressional Intervention on Final FDA Rule
During a Capitol Hill briefing for congressional staffers that took place July 9, the CAP discussed how Congress can promote patient safety without overburdening laboratories through enacting a diagnostic reform package that provides oversight of laboratory-developed tests (LDTs) while still allowing for innovation of new technologies and patient access to accurate testing. The Capitol Hill briefing featured top pathologists from around the country who provided background on LDTs and answered questions from congressional staffers.
Donald Karcher, MD, FCAP, the CAP’s President and Joe Saad, MD, FCAP, President, Surgical Pathologists of Dallas presented congressional staff with CAP’s concerns that the FDA is moving forward with its regulatory oversight plan for LDTs without making the additional changes needed to ensure both patient safety and access to accurate and innovative testing.
The physicians explained what LDTs are and why they are important, the impact of the FDA’s diagnostic rule on the provision of LDTs and patient testing, and why congressional intervention through legislation like the Verifying Accurate Leading-Edge IVCT Development (VALID) Act, not the FDA final rule, provides the necessary oversight to ensure safe, quality laboratory tests for all patients. Read the press release here. For more information visit the CAP’s Laboratory-Developed Test Oversight webpage.