Posted: 21 Nov 2016 06:21 PM PST
By Allyson B. Mullen & Jeffrey N. Gibbs –
All this year, FDA had signaled it intended to finalize the guidance for Laboratory Developed Tests (LDTs). On Friday November 18, 2016, FDA abandoned the effort, stating that it will not provide the requisite 60-day notice to Congress to finalize the Draft Guidances for LDTs (see here and here). FDA issued the draft guidances in late July 2014, and since then the draft guidances have received a mix of praise and criticism, as we have discussed in our earlier blog posts (here, here, and here).
FDA’s announcement is unsurprising in the wake of the unexpected election results. While this announcement is framing the current status of the draft guidances as delayed, given the current political landscape, these draft guidances are dead for all intents and purposes. Republican members of Congress have been among some of the harshest critics of FDA’s proposal to expand regulatory oversight of LDTs. FDA did say it would “continue to work with stakeholders, our new administration, and Congress to get our approach right.” FDA also said, “We plan to outline our view of an appropriate risk-based approach in the near future.” Nevertheless, with a Republican President committed to less regulation and Republican majorities in both the House and Senate, we believe FDA’s efforts to issue far-reaching LDT guidance is moribund for many years.
With that in mind, what does that mean for laboratories currently running LDTs? If sweeping guidance is off the table, it still does not mean FDA will ignore labs. We don’t have a crystal ball, but we do have a few ideas (i.e., pure speculation).
First, it is unlikely that FDA will view its core mission of ensuring that only “accurate, reliable, and clinically valid” tests are available to customers as changed even with a new administration. Nor do we expect some of FDA’s major concerns with LDTs to abate. Therefore, we expect FDA will take enforcement action against tests that it believes are providing “inaccurate or false test results.” A few ways that we could see this manifest are:
As our readers know, a tremendous amount of resources from both FDA and industry was dedicated to the LDT regulatory efforts of the last two years (and before that). For example, the Diagnostic Test Working Group (DTWG), an independent group consisting of representatives from diagnostic manufacturers and clinical laboratories was created to develop alternatives to FDA draft guidances. Congress worked on legislative alternatives to the draft guidances, and the administrative agencies related to LDTs created an interagency task force, which included FDA, CMS, CDC, and NIH, to work on revising the draft guidances. FDA spent countless hours revising its draft guidances, and industry spent countless hours commenting and then lobbying.
While some of the discussions were unproductive, reflecting polarized views, we hesitate to say that these efforts were all wasted because certainly some good ideas have come out of the process. FDA has learned much about the scope, nature, and importance of LDTs, and industry has learned about FDA’s perspective. This may, however, also mean that FDA now has greater knowledge of how to expand enforcement actions to regulate LDTs. Only time will tell. We will certainly be keeping a close eye on how FDA proceeds from an enforcement standpoint and will keep you all updated.
Finally, FDA first announced its authority to regulate LDTs over 24 years ago. Even if the path to broad LDT regulation is blocked for now, FDA may continue to bide its time. In 2021, LDTs will still be around, and so will FDA. The story may not be over.