LDTs

Congress Reintroduces Rival VALID and VITAL Acts to Regulate New Lab Tests

VALID and VITAL are familiar acronyms to those of you who’ve been following the long-running effort to impose order on the FDA’s regulation of Laboratory Developed Tests (LDTs). Now both of those bills have been reintroduced in Congress. And this time, one of them might actually pass. Here’s a quick briefing on each bill and how it would regulate LDTs.

Current State of LDT Regulation

Because lab tests weren’t part of the original FDA legislation, the agency has regulated LDTs, aka, in vitro clinical tests (IVCTs) by expanding its authority to regulate medical devices. Currently, LDTs are cleared via the 510(k) premarket review pathway with the FDA making up the rules as it goes along via informal guidance without following the notice of rulemaking process for federal regulation. In the meantime, the FDA has also practiced what it calls “enforcement discretion” and deferred regulation of most LDTs to CMS under CLIA.

One of the earliest legislative efforts to clean up the mess was a bill called the Diagnostic Accuracy and Innovation Act (DAIA) that would have removed diagnostic tests from the definition of a medical device and thus outside the scope of the 510(k) pathway. After getting input from the lab and diagnostics industry, legislators submitted the DAIA draft to FDA for technical assistance. Instead of the usual technical edits, however, the FDA proposed an entirely new framework to overhaul the 510(k) premarket review program.

Although the FDA’s proposed scheme didn’t gain much traction, DAIA’s sponsors incorporated some of the agency’s ideas, including pre-certification, into a 2018 bill called the Verifying Accurate, Leading-edge IVCT Development (VALID). In March 2020, amid grumblings about the FDA’s inadequate response to the pandemic, VALID was reintroduced.

While the 2020 bill went nowhere, new impetus for reform came from a surprising source in August of that year when the US Department of Health and Human Services (HHS) issued a determination that the FDA can’t require premarket review of LDTs without notice and comment rulemaking. For the lab industry, the determination served as vindication; however, it didn’t solve the larger problem of LDTs regulation.

The VALID Act of 2021

Unlike DAIA, the VALID Act of 2021 recognizes FDA authority to regulate IVCTs, which would become a new product category consisting of LDTs and test kits. VALID would create a risk-based framework for IVCT regulation, with high-risk tests, like novel assays, required to go through premarket review; lower-risk tests could go to market after passing through technological certification. Key features of VALID:

  • Establishment of a technology certification program for lower-risk tests;
  • A requirement that high-risk tests undergo premarket review to verify analytical and clinical validity;
  • Authority of the FDA to require that any test undergo premarket review after providing the developer an opportunity to address issues identified by the agency; and
  • Creation of a new system to allow hospitals and labs to submit their tests electronically to the FDA for approval.

The VITAL Act

VALID isn’t the only LDTs regulation bill on the table. First introduced by Senator Rand Paul (R-KY) in March 2020, the newly reintroduced Verified Innovative Testing in American Laboratories (VITAL) Act would transfer the FDA’s regulatory powers over LDTs to HHS. Supporters of the bill believe that the FDA’s slow response in expanding access to SARS-CoV-2 virus tests during the pandemic reaffirms the need for stripping the agency of power to regulate LDTs. “When we face a health emergency, government should trust academic, community and public health labs to do what they are already trained and certified to do,” noted Senator Paul in a press release at the time. “With all of the debates about how government should respond, here’s one thing it can stop doing: piling counter-productive bureaucratic hurdles in the way of our medical professionals.”

Subsequent FDA management of the EUA process seemed to vindicate and strengthen the drive to get the agency out of the business of regulating LDTs. In August 2020, HHS issued a determination stating that the FDA cannot require premarket review of LDTs without notice and comment rulemaking. While not eliminating FDA regulatory authority over LDTs, the HHS determination barred the agency from its traditional—and to most in the industry—infuriating practice of exercising that authority via website guidelines and other informal pronouncements serving as shortcuts around the burdensome notice and comment rulemaking protocols.

“In the earliest and most frightening days of the pandemic, CLIA-accredited academic clinical laboratories could have used their valuable expertise and resources to expand SARS-CoV-2 diagnostic testing in their communities, but were unable to do so due to inappropriate FDA restrictions,” she continued. “Priceless weeks were lost, making the urgency to address these issues now even more clear.”

Takeaway

The FDA’s handling of COVID-19 tests in response to the pandemic exposed the truth of what the lab industry has been saying for over a decade: The agency’s ham-handed and ad hoc regulation over LDTs thwarts innovation and keeps vitally needed new tests from reaching the market. While the VALID and VITAL Acts aren’t new, the impetus and urgency to do something about FDA LDTs regulation most certainly are. This suggests that change is really going to happen this time.

What exactly that change will be, however, remains unclear. Maybe the FDA will be stripped of its LDTs regulatory powers; but even if that doesn’t happen, the agency will have to follow a set of specific ground rules and procedures designed to ensure that new lab tests get to market more rapidly. The new transparency and predictability should also go a long way toward encouraging lab companies to innovate and develop new testing products.

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