Home 5 Lab Industry Advisor 5 Essential 5 LDTs: Congress Set to Scuttle VALID Act at the Eleventh Hour

LDTs: Congress Set to Scuttle VALID Act at the Eleventh Hour

by | Sep 30, 2022 | Essential, Laboratory Industry Report, Legislation-lir

Congress reportedly set to pass a stripped-down version of the FDA user fees bill without the VALID Act component regulating LDTs.

You know how Lucy pulls back the football just as Charlie Brown approaches to kick it? No matter how many times he falls for the trick, he keeps believing Lucy will keep that doggone ball on the ground only to have his hopes dashed at the very last moment. You can forgive the lab industry for feeling a bit like Charlie Brown lying on his back. In this case, Congress is Lucy and the football is the Verifying Accurate Leading-edge IVCT Development Act (VALID) establishing a new FDA regulatory regime over laboratory developed tests (LDTs).

The Need for LDTs Reform

Congress wasn’t thinking about LDTs back in 1938 when it enacted the Food, Drug, and Cosmetic Act establishing the FDA’s regulatory authority over new drugs. Nor were LDTs on lawmakers’ minds when they adopted the Medical Device Amendments of 1976. The agency stepped into this regulatory vacuum by extending its authority over medical devices to include in vitro clinical tests (IVCTs). The move went largely unchallenged, leaving the FDA to regulate LDTs on an arbitrary basis outside the federal rulemaking process.

For decades, this arbitrary regime has frustrated producers of LDTs and kept badly needed new tests from reaching the market. Move for reform has proceeded at a glacial pace. The FDA floated a proposed rule in 2016. Congress also soon got into the act, generating a number of bills, some preserving and others stripping the FDA of LDTs regulatory authority. The COVID-19 pandemic and dire shortage of lab tests in its early months brought the issue to a head. In 2020, the Trump administration stripped the FDA of regulatory authority over LDTs, a move that the Biden administration reversed a year later.

OIG Rips FDA for Letting Junk COVID-19 Tests Reach the Market

The FDA needs to clean up its Emergency Use Authorization (EUA) policy so that it doesn’t allow unproven tests of dubious quality to reach the market the next time an infectious disease emergency breaks out. That’s the finding of a new U.S. Department of Health and Human Services Office of Inspector General (OIG) report concluding that during the early months of the COVID-19 emergency, the FDA made the “calculated decision” to increase test availability by allowing test makers to distribute their tests upon validation without undergoing EUA review, provided that they notify the agency later. Flexibility in the face of crisis is all well and good, but the agency had “no roadmap” for achieving a balance between test availability and test performance, the OIG concludes.

The New VALID Act

Meanwhile, Congress proposed a new version of the VALID Act that would create a risk-based framework for IVCTs by requiring premarket review for high-risk tests while allowing lower-risk tests to reach the market after passing a far less stringent technological certification process. The new VALID Act would also allow labs and test makers to make changes to moderate-risk tests that reach the market without undergoing premarket FDA review. Certain LDTs already on the market before the new VALID Act took effect would also be exempt from premarket review requirements. However, the FDA would be able to impose the new regulations if the test is modified or the agency otherwise finds that:

  • It’s backed by insufficient supporting scientific evidence;
  • Deceptive or fraudulent claims about the test are made; or
  • The test poses risks of serious adverse health consequences.

While supported by major labs like Quest Diagnostics and LabCorp, as well as their representative, the American Clinical Laboratory Association (ACLA), the new VALID Act has drawn opposition from academic and other labs that actually develop LDTs who think the bill is too financially onerous on smaller labs without the resources of the commercial lab giants.

The Track to Passage

For a while, it looked like the new VALID Act would fare little better than its predecessors. But back in the spring, VALID proponents seized upon what they believed was a strategic opportunity to secure fast passage by attaching the bill, along with several other healthcare “riders” to the legislation reauthorizing the FDA user fee system. This created an urgency to the extent that Congress had until Sept. 30 to pass legislation to keep the user fee system running. In June, the House of Representatives passed the user fee bill, including the VALID rider. Only the Senate stood in the way of passage.

But the legislative strategy seems to have failed. Instead of adopting an omnibus FDA bill, Congress has reportedly decided to pass a stripped-down version of the user fees bill via a continuing resolution as part of a wider move to avoid a government shutdown. As a result, VALID and the other riders apparently won’t get through the goalie and will have to be debated on their own merits.

Of course, LDTs reform is a big deal that does deserve the full attention of lawmakers and other stakeholders. At the same time, an opportunity has clearly been missed. The new VALID Act will now have to go it alone, something none of its predecessors have been able to do.

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