FDA's Proposed Changes To LDT Classification Stir Controversy Over Innovation & Patient Access
According to the media reports, the US Food and Drug Administration (FDA) has ignited a debate with its recent proposal to reclassify laboratory-developed tests (LDTs) as medical devices. However, critics, exemplified by ARUP Laboratories and CEO Andy Theurer, express apprehensions, fearing potential stifling of innovation and limited patient access, especially for rare diseases, the reports in the media added.
GlobalData's Medical Analyst, Selena Yu, emphasises the importance of finding common ground between regulatory bodies and healthcare innovators. She notes, "The ongoing debate centres on finding common ground between regulatory bodies and healthcare innovators, striking a balance that ensures patient safety without hindering the development of new and essential tests."
Opponents argue that the proposed regulatory framework may impede innovation in new test development. Navigating the complexities of LDTs in the US testing market poses challenges, with limited transparency on materials used and major players. The potential impact on test development timelines and delays in patient access to crucial innovations are key concerns voiced by critics.
GlobalData's Device Approval Analyser Database indicates an average timeline of 5.9 years for test development in the US, while the approval process for devices takes eight to 13 months. The fear of delays in patients accessing life-saving innovations is a significant worry, especially considering the setbacks faced during the pandemic, where non-COVID-19-related in vitro diagnostic (IVD) device approvals were hampered due to the prioritisation of emergency use authorisations (EUAs).
Yu concluded, "The coming months may witness further discussions, potentially leading to adjustments in the proposed regulatory changes to address concerns." The ongoing debate underscores the need for a comprehensive solution that ensures patient safety without compromising the development of vital diagnostic tests.
