FDA Will Not Finalize Draft LDT Guidances in 2016 – But That’s Not the End of LDT Regulation

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:

• Stepped Up Enforcement of the 2013 Final RUO/IUO Guidance. Since FDA finalized its Guidance Document regarding Research Use and Investigational Use devices in October 2013, there has been virtually no public enforcement action. This lack of activity came as a surprise to many, including us. After release of the draft LDT guidances less than a year later, it appeared that FDA was focusing on an even broader initiative: LDT regulation. Now that the LDT efforts are done (at least in their current incarnation), FDA may turn its attention back to the marketing of RUOs and IUOs used in LDTs.

• Expansion of Tests that Do Not Meet the Definition of an LDT (e.g., direct-to-consumer (DTC) tests). As many of you are well aware, FDA says it will not exercise enforcement discretion over DTC LDTs. What, exactly, is DTC remains undefined. We had thought that a test ordered by a physician was not DTC, since there was a physician intermediary. FDA disagrees. It is not enough that a physician order the test. FDA has looked at other factors, such as the degree of physician independence. FDA has not, however, publicly articulated these criteria for determining DTC status. Thus, many laboratories struggle to understand how much and what kind of physician interaction is necessary to make a test non-DTC. Now that FDA’s attempt to broadly regulate all LDTs has ended for now, FDA may well attempt to narrow exempt LDTs by expanding the scope of LDTs deemed DTC.  

• Collection Devices. FDA has also historically attempted to regulate (i.e., stop availability of) certain LDTs by preventing the distribution of the collection device necessary to obtain a patient sample for testing. FDA has claimed that the collection device is adulterated and/or misbranded for failure to have clearance or approval for sample collection for the LDT’s intended use. Numerous LDTs use general purpose patient sample collection devices. FDA could try to assert greater oversight of the lab test process by requiring premarket clearance or approval for collection devices for specific intended uses. 

• Public Announcement of “Safety” Concerns. FDA could take another approach and tell consumers and physicians that there are perceived “safety” risks with a particular test or group of tests. In fact, almost a year ago FDA issued a guidance regarding “Public of Emerging Postmarket Medical Device Signals” (see our blog post here). We criticized the draft post for failing to consider industry input before FDA makes an announcement because it could, in part, stop the use of a clinically valid and scientifically sound product. We saw FDA take such action recently with respect Ovarian Cancer Screening Tests. In September, FDA issued a safety communication stating that individuals should not use such tests. FDA did not cite a single confirmed instance of harm from any of these tests – all of the harm cited was theoretical. If FDA chooses to regulate LDTs in this way, we could see an increase in the number of “safety” communications. As a practical matter, this kind of notice and the resulting publicity can kill a test, even though the company never got a chance to address FDA’s concerns before publication.

• Narrowing LDTs. FDA has rarely, in recent years, challenged laboratory tests as not qualifying as LDTs. FDA, though, has done so in the past, and could do so in the future. Given the elastic definition of an LDT, it would not be hard to imagine FDA saying that certain tests don’t qualify as LDTs.

Thus, while many in the lab community have been praising the announcement from FDA, in our view, this fight may not be over. It may now shift from a battle over sweeping guidelines to case-by-case challenges using ill-defined criteria.

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.