Experts look to VALID for diagnostic reforms, offer reassurance to lab industry

Regulatory NewsRegulatory News | 26 October 2022 |  By 

Left to right: Nathan Brown, Carly McWilliams, April Veoukas, and Elizabeth Hillebrenner

BOSTON, MA – A panel of experts at the 2022 annual Medtech Conference hosted by AdvaMed noted that diagnostics reform proposed in the Verifying Accurate Leading-edge IVCT Development (VALID) Act won’t affect all laboratory-developed test (LDT) producers and has provisions to address unmet needs.
The panel on the state of the diagnostics industry largely discussed the future of the VALID Act and was moderated by Nathan Brown, a partner at Akin Gump Strauss Hauer & Feld. He was joined by Elizabeth Hillebrenner, associate director for scientific and regulatory programs at the US Food and Drug Administration (FDA); Carly McWilliams, head of North America regulatory policy at Roche Diagnostics; and April Veoukas, director of regulatory affairs at Abbott.
While the VALID Act nearly made it into the recently reauthorized user fee legislation, it has faced pushback from the LDT industry, including from academic medical centers. The bill was ultimately stripped from the user fee package, but some have pushed for it to be passed as part of the December omnibus spending bill.
Hillebrenner noted that the proposed legislation has evolved in many ways over the years and now includes provisions on how tests can be grandfathered and a rule that allows the FDA to request information from grandfathered in vitro clinical test (IVCT) makers.
“There's a lot of confusion out there. People think that we're going to call these all in for premarket review, and I think a prior version of VALID did say that they could come in for premarket review,” said Hillebrenner. “But that’s evolved as well and now it's just that we would be able to ask for the information about a specific concern.”
Ultimately Hillebrenner said the FDA is pleased with how the bill has evolved in Congress, though she expects more changes.
“I think there's probably a little bit more tinkering that might be done around the edges, but I think it's a really good bill, and we're hopeful to see it passed,” she added.
Brown said that different segments of the lab community have argued for either an easier and smoother transition or some type of carve-out, though he noted that the central part of such arguments comes down to addressing unmet medical needs.
Veoukas pointed out that there are specific provisions in the latest version of the bill to address the kinds of unmet needs that groups such as academic medical centers are using for their carve-out rationale. They include humanitarian test exemptions for diagnostic purposes for diseases intended to treat less than 10,000 people and manual test exemptions.
“There are a variety of areas where VALID has really contemplated unmet needs and put in some expectations as to what would be required,” said Veoukas. “There is recognition of the variety of stakeholders and uses of IVCT products and has addressed provisions to accommodate those.”
Veoukas said she too is open to the idea of further discussions about how unmet needs can be addressed in a future version of the bill, though she didn’t explicitly say a carve-out for academic medical centers was unnecessary.
McWilliams, a former legislative staffer at the House Energy and Commerce (E&C) Committee and former senior counsel to the FDA commissioner, noted that the VALID Act has been around for her entire career. Over the years, she said the bill has significantly evolved from being a cumbersome idea that was supposed to be a part of the 21st Century Cures Act and included creating a new center at the FDA to regulate IVCTs to one that gives the agency and industry more flexibility.
“VALID is complicated but what we were looking at was extraordinarily complicated,” said McWilliams. “I think it’s gotten to be a much more pragmatic, simplified approach.”
In particular, she singled out the addition of a moderate-risk category instead of the original two-tiered category that the lab industry was concerned was too dichotomous and did not address certain tests that fall in between high and low risk.
If VALID does pass come December, Hillebrenner said the FDA will immediately begin outreach to industry and other stakeholders to figure out how to develop the regulations as directed by the law, including on coming to an understanding of how to define validation and what validation looks like under different circumstances. She also said the agency will need to figure out how many new tests are on the market that it needs to regulate, because right now that data is not available.
Hillebrenner added that VALID does lay out a five-year timeline for developing guidances and holding public meetings.
“I think just having a level playing field where all tests are subject to the same framework and everybody is expected to be analytically and clinically valid, in and of itself, will help innovation,” said Hillebrenner. “Some developers might be making claims that might not have very strong science behind them and then another developer starts to compete with that and it's like a spiraling of these claims.”
“I think this framework will help with that and it will help with clarity and predictability,” she added. “If you have consistent standards applied across the board, I think from the bigger picture that will help innovation overall.”


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