IDSA Advocates for Patient Access to in vitro Diagnostics
IDSA has continued to take a central role in ongoing policy discussions regarding access to diagnostics and regulation for laboratory developed tests.
VALID Act updates and access to diagnostics
The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020 was introduced March 6 in the Senate by Sen. Richard Burr (R-NC) and Sen. Michael Bennet (D-CO) and in the House by Rep. Diana DeGette (D-CO) and Rep. Larry Buschon (R-IN). The revised bill followed an earlier draft and 15 months of sustained physician, laboratory and industry engagement with congressional staff.
IDSA appreciates the improvements to the bill that the sponsors have made and their willingness to continue working with our members, and we support federal efforts to expand access to diagnostic testing during the COVID-19 pandemic and future public health emergencies. The VALID Act, however, introduces new and duplicative regulatory hurdles for laboratories developing tests for numerous conditions that are not public health emergencies but are nonetheless critical in everyday patient care. The current pandemic illustrates the life-threatening implications for patients and public health posed by inadequate access to testing. IDSA is concerned that VALID will further limit access to testing at academic medical centers and hospital laboratories, creating the shortage we are seeing with COVID-19 and in other infectious disease diagnostics.
Additional concerns with the bill include insufficient testing thresholds for rare diseases (<10,000 tests annually) and the exclusion of communicable diseases from rare disease exemptions, along with U.S. Food and Drug Administration user fee requirements that not-for-profit laboratories will be unable to afford. For those reasons we are urging Congress not to advance VALID until we address immediate challenges and thoroughly assess impacts on patient care.
IDSA on the Hill
IDSA Board member and former Diagnostics Committee Chair Kim Hanson, MD, met with VALID Act House cosponsors and leaders of the congressional committees with jurisdiction over this bill on March 12 to share IDSA’s concerns with the bill and recommendations regarding COVID-19 response. IDSA will continue to educate members of Congress about the critical role laboratory developed tests for infectious diseases play in patient care and public health.
IDSA maintains that any new policies regarding the oversight of laboratory tests should preserve access to high quality diagnostic tests that improve the management and outcomes of life-threatening infectious diseases.