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May 9, 2018

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Leading Advocacy Efforts to Preserve Access to In Vitro Diagnostics

The current draft of the Diagnostic Accuracy and Innovation Act (DAIA) contains prohibitive regulatory and budgetary implications for laboratory developed tests and threatens to wipe out many of the tests ID physicians use to manage some of the most seriously ill patients. The draft, which proposes that LDTs be regulated as a new category of in vitro clinical tests under FDA jurisdiction, has remained in discussion draft form since its March 2017 introduction. However, FDA is in the process of providing technical assistance on the discussion draft and congressional attention may turn back to diagnostics regulation as soon as early summer. 

In a continuation of our ongoing advocacy efforts on this issue, IDSA sent a letter to FDA Commissioner Gottlieb on April 27 outlining the Society’s concerns about the impact of DAIA on the ID and public health communities.

Shortly thereafter, FDA released feedback on the discussion draft containing proposed legislative principles, areas of consensus, and concerns. IDSA was pleased to learn that FDA supported our suggested regulatory exemptions for LDTs developed for public health surveillance, emergency use, and rare diseases; however, more needs to be done to better define suggested approval pathways, exempted test classes, and funding mechanisms. 

IDSA met with House Energy & Commerce Committee staff last week to discuss our concerns with the DAIA discussion draft and opportunities to educate Members of Congress on the impacts of access to ID LDTs on patient care and public health. We will continue to work with federal agencies and our stakeholder partners to advocate that any new policies regarding the oversight of laboratory test approval maintain access to high-quality testing options and promote innovation. 

If you would like to learn more about IDSA’s work on this issue or share feedback on how the draft DAIA legislation may affect your practice, laboratory, or institution, please email Jaclyn Levy, IDSA’s Senior Program Office for Science & Research Policy.

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