The COVID-19 pandemic exposed the truth of something the lab industry has known and publicly stated repeatedly for over a decade: The FDA is ill-equipped to regulate Laboratory Developed Tests (LDTs) and allowing it to continue to do so, at least under its current model, stifles innovation and keeps needed tests off the market. Of course, many members of Congress on both sides of the aisles have shared in this knowledge. And now an increasing number of their colleagues do, as well. Accordingly, the renewal of efforts to impose legislative order might actually come to fruition this time. The spearhead of those efforts, at least for now, is the reintroduction of a pair of bills that failed to take hold the last time they were on the table: the VALID and VITAL Acts. Here’s a quick briefing on the 2021 version of each bill and how it proposes regulate LDTs.
[freereport]
The FDA’s Ham-Handed Regulation of LDTs
The original Food Drug & Cosmetics Act legislation doesn’t provide for regulation of lab tests. The FDA claims that its authority to regulate LDTs, aka, in vitro clinical tests (IVCTs), is rooted in its power to regulate medical devices. To fit this square peg into a round hole, the agency clears LDTs via the 510(k) premarket review pathway. Since there’s no statutory or regulatory basis for any of this, the FDA makes up the rules as it goes along. Adding to the arbitrariness is that the agency exercises its oversight of LDTs by issuing informal guidance rather than following the strict notice of rulemaking process designed to ensure comment and review for federal regulation. In parallel, the FDA has also practiced what it calls “enforcement discretion” by deferring 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 placed it 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 while maintaining its own authority of IVCTs.
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 slow, haphazard and overall inadequate response to the pandemic-fueled need for new SARS-CoV-2 tests, 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 U.S. 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:
High-Risk Tests: High-risk tests, like novel assays, would be required to go through premarket review to verify analytical and clinical validity.
Lower-Risk Tests: VALID would establish a separate technological certification program for lower-risk tests, as well as a new system allowing hospitals and labs to submit their tests electronically.
Emergency Use Tests: To speed up the EUA bottleneck, validated tests would be authorized to use for emergency purposes pending review of their EUA clearance, analogous to the notification process FDA used for certain COVID-19 tests during the early days of the public health emergency.
Grandfathered Tests: Qualifying LDTs offered for clinical use before enactment of the legislation would receive “grandfathered” status and not require premarket review, provided that they:
- Carry a disclaimer on the label;
- Aren’t modified; and
- Aren’t flagged by the FDA as posing a special concern.
Transitional Tests: IVCTs first offered between the date VALID is enacted and 90 days after it takes effect would be allowed to remain on the market as “transitional” IVCTs, provided that the test maker submits a timely marketing application to the FDA.
Other key features of the 2021 version of VALID:
- Establishment of test design and quality requirements for IVCTs, equivalent to the current Quality Systems requirements for medical devices;
- Creation of a new process that the FDA can use to request information from an otherwise exempt IVCT, such as a transitional or grandfathered test, in certain situations;
- Authority of FDA to participate in collaborative communities for purposes of “facilitating community solutions and decision-making” for IVCTs;
- A requirement that FDA create and maintain an IVCTs database that’s more extensive than the current device registration and listing database; and
- New IVCT adulteration, misbranding and postmarket surveillance requirements mirroring current rules that apply to medical devices.
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.