What happened?

On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket review of Laboratory Developed Tests (“LDTs”) and eliminating the requirement for premarket review of LDTs, in the absence of notice-and-comment rulemaking. Submission by labs of a premarket approval application, premarket notification, or Emergency Use Authorization (“EUA”) request may be done on a voluntary basis – and FDA will adjudicate voluntary submissions.

FDA oversight of LDTs, defined by FDA as in vitro diagnostic tests that are intended for clinical use and designed, manufactured, and used within a single laboratory regulated under the Clinical Laboratory Improvement Amendments of 1998 (CLIA) program, is a matter of on-going debate. Given the timeframe generally required for notice-and-comment rulemaking, in the near term the announcement effectively, and dramatically, decreases FDA’s current discretion with respect to oversight of LTDs, including those used to detect SARS-CoV-2, the virus responsible for the current COVID-19 pandemic, and its antibodies (“COVID-19 LDTs”). HHS provided little explanation for the sudden shift in approach, noting only that the decision is “part of HHS’s ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19” consistent with the Trump Administration’s efforts to reduce regulatory burdens (see Executive Orders 13771 and 13924).

The announcement does not impact in vitro diagnostic tests that are not LDTs, including tests manufactured by one company and then sold to a lab, or labs with active EUAs for COVID-19 LDTs. Further, HHS’s announcement does not change any existing CLIA program requirements; labs releasing patient-specific results of LDTs for health care purposes still need to abide by any applicable CLIA registration, validation, and other requirements, found at 42 U.S.C. § 263a and 42 C.F.R. pt. 493.

Former FDA Commissioner, Scott Gottlieb, MD, took to Twitter to express his concern with the announcement, stating that “FDA might not be able to provide critical advice to test developers or take needed enforcement actions against bad tests” and questioning “how can FDA take action over something HHS says it doesn't regulate?” Likewise, Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) issued a statement denouncing HHS’s actions, commenting “[t]his week’s announcement from HHS that lab developed COVID-19 tests no longer need review by FDA prior to coming to market is deeply concerning and suggests that the Trump Administration is once again interfering with FDA’s regulation of medical products.” Chairman Pallone demanded “a briefing from Secretary Azar on . . . why HHS is doing this now when the need for accurate tests is so critical.”

Why does it matter?

LDTs have been in a legal “gray area” for many years. FDA has asserted oversight authority for LDTs under the Federal Food, Drug, and Cosmetic Act and the agency’s medical device regulations, but generally has exercised “enforcement discretion” with respect to most premarket and post-market requirements. FDA’s approach on LDTs has been defined through a series of website statements, informal guidance documents, public safety notices, discussion papers, and occasional enforcement actions, rather than formal rulemaking. FDA has maintained that it “has not created a legal ‘carve-out’ for LDTs” and that the “agency always retains discretion to take action when appropriate, such as when it is appropriate to address significant public health concerns.” This approach has created an uncertain oversight environment for labs, in part because they cannot readily predict when the FDA might intervene.

Over the last decade, both FDA and Congress have taken steps aimed at addressing the uncertainty and providing a more defined oversight framework. As recently as March 5, 2020, members of Congress re-introduced the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which would create a risk-based framework for the regulation of in vitro clinical tests (a new category of tests including both LDTs and non-LDT in vitro diagnostics), overseen by FDA’s Center for Devices and Radiological Health.

During the COVID-19 public health emergency, FDA has exercised oversight authority over COVID-19 LDTs, requiring premarket EUAs for in vitro diagnostics produced both by labs and by commercial manufacturers. This is consistent with FDA’s approach to the use of diagnostic tests in prior public health emergencies. However, some have blamed FDA’s review process for the delay in bringing COVID-19 diagnostic tests to market and the announcement appears to be aimed at responding to those concerns.

What’s next?

Labs producing COVID-19 LDTs without active EUAs for SARS-CoV-2 will need to evaluate whether to pursue an EUA (on a voluntary basis) or offer testing without a premarket submission, in reliance on the announcement. Moving forward without an EUA may come at a cost, however, since HHS indicates in the statement that labs offering diagnostics without FDA premarket review or authorization will not be afforded immunity under the PREP Act, a law intended to shield health care providers and others from liability in connection with SARS-CoV-2 countermeasures. However, the impact of the HHS statement on the FDA’s authority also raises questions about the value of an active or voluntarily obtained EUA with respect to asserting PREP Act immunity. One certainly can envision a challenge to immunity on the grounds that an EUA, which FDA now lacks authority to require absent rule making, confers no formal permission warranting PREP Act coverage.

Labs producing non-COVID LDTs will need to consider the long-term implications of the announcement. The announcement does not dictate FDA’s ultimate authority over these tests, an issue that is now deferred until such time as FDA may initiate a formal rulemaking process, the announcement itself is rescinded, or Congress agrees upon a more comprehensive framework for LDT oversight.

Labs will want to follow closely further developments in this area. If you have any questions, please contact your regular Verrill attorney.