Testing overhaul faces a narrow pathway to pass before year end

A bill that would create a new, risk-based framework for diagnostic tests has a “narrow pathway” to pass before the end of the year, industry groups told MedTech Dive.

The VALID (Verifying Accurate Leading-edge IVCT Development) Act was initially included in a Senate package to reauthorize the Food and Drug Administration’s user fee programs for the next five years. The act was struck from the final package, along with all other amendments, in a last-minute effort to pass the authorization before the end of the federal fiscal year.

Leaders of the Senate Committee on Health, Education, Labor and Pensions and the House Energy and Commerce Committee said they plan to revisit the struck amendments before the end of the year as part of a year-end omnibus spending bill.

The VALID Act has been in the works since 2018 and would overhaul the current system for regulating diagnostics with a risk-based approach. This clarifies the FDA’s authority to regulate laboratory-developed tests (LDTs), which are developed, evaluated, and validated by one laboratory, and have previously been exempted from clearance or approval requirements through enforcement discretion. If passed, the policy would not apply to lab-developed tests that are already on the market.

Even with bipartisan support and commitments from both committees, the policy could still face some hurdles in passing before the end of the year, experts said.

“There is a narrow pathway for VALID in an end-of-year package, along with other FDA-related policies,” the American Clinical Laboratory Association wrote in an email. “Discussions on the bill are ongoing and ACLA continues to engage with the committees of jurisdiction.”

James Boiani, an attorney with New York-based law firm Epstein Becker Green, said in an interview the bill has a “reasonable chance” of passing by the end of year.

“Even though it has pretty broad support… there have been concerns in the past about disrupting the current LDT framework where lab-developed tests need to be approved,” he added.

Concerns from academic medical centers
While medtech groups including Advamed have largely supported the proposed regulatory overhaul, some academic medical centers have raised concerns. Several large health systems, the Association for Molecular Pathology and the Association of American Medical Colleges signed a May letter to Congress raising “significant concerns” about the VALID Act.

“The party that would be impacted most would be the people that are losing the ability to make LDTs,” Boiani said. “The larger clinical labs are probably less concerned about it, maybe in part because New York state manages its own [Clinical Laboratory Improvement Amendments] program and they’ve sort of established their own approval process for evaluating tests.”

Larger testing companies that already had to go through New York might be more comfortable with going through an approval process, he said.

What will it take to pass the bill?
Advamed CEO Scott Whitaker said understanding academic medical centers’ concerns is key to getting the legislation across the table.

“I think that’s the big issue,” he said in a press conference on Thursday. “It’s not crystal clear to us what exactly their concerns are. And we’ll need to know that in order to get it done.”

The process of attaching the legislation to a year-end funding bill could also introduce more political dynamics into the mix, Whitaker added.

“You may have people who support VALID for example, but might not be able to support the weight of the entire bill. And that complicates the final vote process a little bit,” he noted.

The results of mid-term elections in November also may affect what happens with the bill.

“Today, it looks like it has a reasonable chance of passing, but that could change depending on how the elections go,” Boiani said, adding that “the atmosphere on the hill had kind of soured.”

If both houses flip, there would be less incentive to work on the VALID Act, he added.

What happens if Congress doesn’t get it done before December?
If the bill doesn’t pass before the end of the year, it’s likely that a revamp of regulating lab-based testing would fall under the FDA’s purview, Advamed’s Whitaker said.

“I think FDA certainly will do something, but what we’ve seen from the FDA is a willingness to engage with industry when they do something like this and try to make sure that it’s right,” he said. “I don’t fear that, but I hope we don’t have to get to that place, that it’s better if Congress prescribes exactly what it looks like.” MedTech Dive