Last week, Stanford Biodesign hosted a webinar on the FDA proposal to regulate LDTs.
They've now posted the one-hour video online at their YouTube channel. Find it here:
In a conversation moderated by Stanford Biodesign Policy Program director Kavita Patel, ACLA president Susan Van Meter, physician executive Bruce Quinn, and Stanford Biodesign's director of policy research Sandra Waugh Ruggles discuss the Food and Drug Administration's proposed language on laboratory developed tests (LDTs), and the potential impact on clinicians, patients, and innovators.
Not mentioned in the webinar, a former FDA attorney's guide to the FDA's legal weaknesses:
I've included an AI summary below from ChatGPT [some manual edits].
This webinar from the Stanford Biodesign Center focused on the FDA's regulation of Laboratory Developed Tests (LDTs). The discussion centered on the FDA's proposed rule which appeared following Congress's failure to pass the VALID Act. (VALID hadsought to establish a new framework for the regulation of LDTs.)
The panelists expressed disappointment with the proposed rule, seeing it as a blunt instrument that could stifle innovation and patient access to essential tests. They highlighted the need for a regulatory framework that acknowledges the unique characteristics of LDTs, as opposed to applying the legacy 1976 medical device regulatory framework.
The proposed rule's timeline was criticized for being too short to accommodate the industry and FDA's needs adequately. There were concerns about the ability to maintain access to high-risk LDTs due to the short timeline for submission requirements. The panelists also expressed legal concerns, doubting the FDA's authority under current law to regulate LDTs as medical devices. The FDA's somewhat irregular approach to laying out a cost-benefit argument was critiqued.
Significant points of contention included the lack of a grandfathering policy for existing LDTs, the absence of provisions for rare disease testing, and the potential negative impacts on innovation, particularly for small-scale tests and those from academic medical centers. The discussion highlighted the potential chilling effect on new diagnostics development, increased capital requirements, and the need for more strategic planning to navigate the regulatory landscape.
The panelists suggested that the FDA should seek a more nuanced, goal-oriented approach, with a focus on ensuring test safety and controlling claims without imposing excessive costs. They stressed the importance of legislative involvement to create a diagnostic-specific regulatory framework and advised stakeholders to submit comments during the open period to influence the final rule. There was a consensus that the FDA's rule, as it stands, may not be implementable and that any effective regulation must balance patient safety, access, and the facilitation of innovation.