By Gregory Levine, Beth Weinman and Joshua Oyster

Law360 (October 20, 2020, 5:05 PM EDT )

Gregory Levine

Beth Weinman

Joshua Oyster

On Aug. 19, the U.S. Department of Health and Human Services unexpectedly published a notice on its website stating that the U.S. Food and Drug Administration will not require premarket review of any laboratory-developed tests, absent notice-and-comment rulemaking.

On Oct. 7, the FDA for the first time publicly addressed how this announcement will affect the agency's review activities for COVID-19 tests.

Change in the FDA's Emergency Use Authorization Review Priorities

In a new addition to its frequently asked questions website regarding SARS-CoV-2 testing, the FDA explains that it will be "declining to review [emergency use authorization] requests for [laboratory-developed tests] at this time."

The FDA states that the purpose of this change is to make the best use of its resources for the greatest public health benefit in light of the significant number of COVID-19 tests currently authorized to be run in laboratories, and because of "the recent HHS announcement that FDA will not require premarket review of [laboratory-developed tests]."

The statement also notes that the "FDA continues to prioritize review of emergency use authorization, or EUA, requests for [point-of-care] tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, widely distributed tests."

Shortly after posting its new FAQ on Oct. 7, FDA hosted a virtual town hall during which agency personnel addressed questions related to its decision to end review of EUA requests for laboratory-developed tests, or LDTs. Key takeaways from that discussion include:

• The FDA will not continue to review previously submitted EUAs for LDTs.

• Prior to announcing its new policy, the FDA completed its reviews of LDT EUAs that were close to the finish line.

• The FDA will notify submitters of EUAs for LDTs in writing that their submissions will not be reviewed.[1]

Unanswered Questions for the Laboratory Industry

Not surprisingly, the FDA's announcement and subsequent town hall comments leave a number of questions unanswered. We do not yet know exactly how the FDA will define LDTs when considering which EUAs it will decline to review. More insight into this question may be obtained by looking at any EUAs that the FDA may issue to laboratories in the coming weeks or months.

In addition, although the FDA has explained that it will continue to prioritize home collection tests, it has not made clear whether it will continue to review EUA requests for LDTs performed on specimens collected at home. More likely, the FDA will review EUA requests for at-home specimen collection kits and devices that may be used with LDTs, but not any associated LDT assays.

It also remains to be seen what position the FDA will take with respect to use of legally marketed specimen collection kits that are intended for at-home collection, but not specifically indicated for use with COVID-19 diagnostic tests.

Another question is whether the FDA's desire to foster more "high-throughput, widely distributed tests" means the agency will entertain EUA requests for testing programs that rely on high-throughput methodologies developed and performed in a laboratory, with widely distributed specimen collection kits.

Finally, it is unclear whether the FDA's focus on tests that reduce consumption of testing supplies means that the agency will review EUAs for LDTs that use novel supply sparing methods.

Other unanswered questions include why the FDA decided to change its EUA review policy now, and how long its refusal to review EUAs for LDTs will last. The FDA claims this change was prompted both by the increased availability of authorized tests and by the HHS announcement barring it from requiring premarket review for LDTs.

The FDA appears to have decided to focus its limited resources on review of categories of tests that indisputably require its authorization to be legally marketed, and the FDA may have a significant backlog of EUA requests for such tests. Perhaps the FDA will reinstate its review of EUAs when it clears its backlog, or if there is a change in HHS policy, which presumably would occur only if the upcoming presidential election results in a change in administration.

Congressional pressure, such as an Oct. 7 letter from the House Committee on Energy and Commerce to HHS Secretary Alex Azar criticizing HHS's August announcement and the negative impact it could have on the quality and accuracy of LDTs, might also influence the FDA's priorities going forward.

Regardless of what the future holds, for the time being this policy change means that laboratories that develop LDTs for COVID-19 will no longer be able to obtain the potential benefit of Public Readiness and Emergency Preparedness Act immunity or to market their tests as authorized by the FDA.

When HHS made its August 2020 announcement that FDA would not require premarket review for any LDTs, it described as voluntary the decision whether to submit an EUA request to FDA for an LDT. HHS had explained that a laboratory might voluntarily request an EUA because "[a]n EUA triggers PREP Act coverage which immunizes laboratories from suits for loss related to the test."

The FDA's Oct. 7 announcement removes that option for COVID-19 LDT developers, which may create a disincentive for laboratories to continue to develop COVID-19 diagnostics. Quite possibly, because HHS has announced that the FDA can no longer require EUAs for COVID-19 LDTs, the FDA intends to discourage additional LDTs from being developed while that policy remains in effect.

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Gregory Levine is a partner and chair of the life sciences regulatory and compliance practice at Ropes & Gray LLP.

Beth Weinman is counsel at the firm.

Joshua Oyster is an associate at the firm.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] A formal transcript of the virtual town hall is likely to be issued within the next few weeks and will be available on the FDA's website at this link: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-town-hall-series-coronavirus-covid-19-test-development-and-validation-10142020-10142020?utm_source=FDALinkedin.

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