By Rachel Sachs
The Health Subcommittee of the House Energy & Commerce Committee held a hearing last week on the FDA’s proposed draft guidance regarding laboratory-developed tests (LDTs), as part of its “21st Century Cures” initiative. The hearing, which can be viewed online (here and here), featured representatives from the FDA, industry, and research organizations. And although the various panelists offered differing views on the propriety of the FDA’s decision to begin exercising its regulatory authority over LDTs, there seemed to be more agreement than disagreement among the panelists.
Most interestingly, as Representative Henry Waxman pointed out toward the end of the hearing, “[no]body on the panel [is] arguing that there shouldn’t be a very careful scrutiny of these tests. It seems like the question is who should do it: CLIA or the FDA.” Representative Waxman’s subsequent colloquy with Harvard Medical School Professor Christopher Newton-Cheh on this point particularly helped to differentiate the historical roles of CMS and the FDA in this space. But even those panelists who opposed the FDA’s involvement seemed supportive of expanding CMS’ authority under CLIA to conduct clinical validity analyses. (Anyone interested in the administrative law aspects of this issue should know that problems of shared regulatory jurisdiction have recently received increased scholarly attention, with Jody Freeman and Jim Rossi providing a particularly thorough treatment of the issue in their recent article, Agency Coordination in Shared Regulatory Space.)
But perhaps more importantly, it seemed that all parties present were concerned about the relationship between the FDA’s proposal and both innovation and patient care, and simply disagreed about the best way to achieve these goals. Examples of companies that had sought simultaneous FDA approval for both a drug and a companion diagnostic, only to face instantaneous competition in the performance of the diagnostic from LDTs, revealed that the typical innovation analysis is quite complicated in this context.
Several other expected issues also cropped up throughout the hearing. The continued discussions of (and pointed references to) whether LDTs are “devices” (which are subject to regulation) or “services” (which are not) under the FDCA were a reminder that the FDA’s decisions here will surely be opposed in court. Two other issues which I’ve mentioned on this blog before — the availability of patents on these tests as well as reimbursement for conducting them — also rated a mention, if only briefly.
This is certainly an issue to keep an eye on, not only for aficionados of FDA regulation or administrative law, but also for all those interested in innovation law and policy!