CAP Statement on the Release of the Senate’s FDA User Fee Authorization Bill

WASHINGTON--(BUSINESS WIRE)--The College of American Pathologists (CAP) President Emily Volk, MD, FCAP, released the following statement regarding the draft Food and Drug Administration (FDA) user fee authorization bill by the Senate Health, Education, Labor, and Pensions (HELP) Committee. The discussion draft of the bill includes sections of the Verifying Accurate Leading-edge IVCT Development (VALID) Act to provide greater regulatory oversight of laboratory-developed tests (LDTs).

“The CAP has consistently sought changes to ensure patient safety while reducing burdens on laboratories with the Senate HELP Committee on provisions concerning the oversight of laboratory-developed tests. We are reviewing the most recent draft of the legislation for the oversight of LDTs. The CAP looks forward to continued engagement with the Senate HELP Committee to advocate for improvements to address the concerns pathologists have had over prior versions of the VALID Act. The CAP has not endorsed the VALID Act and seeks to ensure safe and quality testing for patients while avoiding burdens and duplication of regulation on laboratories.”

About the College of American Pathologists

As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. As a 501(c)(6) membership organization, the CAP is the only entity representing pathologists with unrestricted advocacy capability and a political action committee, PathPAC. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. Read the CAP Annual Report.