FDA's final guidance on its proposed regulation of laboratory developed tests ("LDTs") is expected in 2015, and debate over whether FDA has the authority to regulate these tests and how it should do so was on full display during an FDA-hosted workshop early this year. The two-day workshop featured a six-segment program organized by issue, during which participants heard from public commenters as well as panelists selected by FDA to represent an array of viewpoints on the six topics.
Many clinical laboratories and pathologists argued that Clinical Laboratory Improvement Amendments regulations are sufficient and that the interpretation of such tests is the practice of medicine, an area outside FDA's purview. Some are concerned that the regulatory framework is too burdensome, would stifle innovation, and that FDA does not have the resources to implement it, which will impair patients' access to not only LDTs but also to other in vitro diagnostic devices undergoing a similar review process. They emphasized the need for a balance between safety and innovation. Others see a role for FDA in regulating the validity of the tests now that they have become so common and are used to diagnose and make treatment decisions for complex and advanced diseases. Biotech investors want a clear path forward and asked FDA to limit the uncertainty by issuing the rule sooner rather than later and to make the process for determining which test falls into which category of regulation more transparent. Representatives of patient and disease-centered groups also conveyed different messages: Some groups focused on the need for prompt access to diagnostic tests and the expected delay in diagnosis due to FDA regulation, while others discussed the negative impacts of false positive and false negative test results on patients and expressed their hope that FDA regulation would help ensure the safety and effectiveness of such tests. A few commenters encouraged FDA to issue supplemental guidance documents on sub-issues like clinical validity and classification, or to reissue another draft guidance after a first round of public comments. FDA officials' comments during the workshop did not shed any light on what they intend to do in the coming months. Comments on the LDT Framework and Notification guidances are due February 2, 2015. Read Jones Day's in-depth analysis of the guidance.
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