The latest version of legislation for regulatory reform has arrived, and the conventional wisdom may be that the Verifying Accurate, Leading-Edge IVCT Development (VALID) Act will not be passed until the next user fee agreement is codified into law. Nonetheless, Susan Van Meter, executive director of AdvamedDx, told BioWorld that the associated reforms are urgently needed by patients and test developers alike, and there is consequently no need to wait for user fee legislation to pass the VALID Act.

The latest version of the VALID Act emerged March 5, and provided a technology certification mechanism that sidesteps the need for a new regulatory review for every iteration of a test type. There are also provisions for federal preemption of state law and third-party review, as well as exemptions for low-volume and custom tests.

Theranos a reason to regulate

The authors of the House version of the VALID Act, Reps. Diana Degette (D-Colo.) and Larry Bucshon (R-Ind.), said the bill would give labs “greater flexibility to respond to public health emergencies.” While the two did not call out the pathogen responsible for COVID-19 by name, they did reference previous outbreaks, including the Ebola virus. They also cited the case of Theranos as an example of a need for more regulatory scrutiny of lab-developed tests (LDTs).

The history of this predicament goes back at least as far as 1976 where the U.S. FDA is concerned, when Congress passed legislation giving the agency the authority to regulate medical devices. Clinical labs have countered with the argument that their tests are processes rather than devices; therefore, FDA regulation would, in effect, interfere in the practice of medicine.

The FDA’s contribution to the legislative discussion includes an August 2018 technical assistance that some saw as more than a mere attempt to provide Congress with a framework for drafting legislation. The VALID Act of 2020 is the second iteration of legislation by that name, although previous legislation to this end also has been circulated on Capitol Hill.

Van Meter said the urgency behind regulatory reform is driven in part by the needs of innovators and by the dawn of the age of precision medicine. The companion diagnostic will increasingly be a staple of modern medical care, but she said its promise will not be fully accomplished until clinical labs have a predictable regulatory environment in which to work.

No need to wait for MDUFA V

Thus, Van Meter said, “now is the time to do comprehensive diagnostic regulatory reform,” adding, “our goal here is to communicate the importance of acting now.” She said the hope at her organization is that the VALID Act is passed well before the legislation that will enable the next device user fee, which won’t be necessary for another two years.

Van Meter said Section 587D of the draft, which describes the technical certification pathway, is voluntary and is “something we need to examine.” She said there are several details about eligibility and scope that her organization will scrutinize in the coming days, although the association is “encouraged that it’s there,” she said. This pathway would allow developers to respond more rapidly to needs for modifications to tests, and “that’s one of the attributes that is really promising,” she said.

On the other hand, Van Meter noted that this mechanism is “quite different” from the pre-cert concept seen in the agency’s still-absent proposal for regulation of software as a medical device. She said the technical certification mechanism imposes a high bar for ensuring that the tests subsumed in the certified platform will work as intended. “We think that’s important and reflects the innovation going on in the field,” she explained.

The provisions for grandfathering existing tests would allow a transition period and spell out not just what the sponsor of the test needs to do to obtain certification going forward, but also how to make the change to the new regulatory framework, Van Meter said. “We’re going to spend a lot of time digging into the details” of this provision, she promised, although it is not yet evident how these provisions would function. The FDA would have some authority to examine the tests that are eligible for grandfathering.

Van Meter said the legislation would provide a publicly available database of tests, including lower-risk ones not subject to review, which she characterized as “an important piece in the package.” However, it is not clear which entity would be charged with setting up such a database, nor how the resources needed to stand up such a system would be obtained.

The sponsors of the legislation “have really stepped up here, and it’s a critical milestone for us,” in terms of regulatory reform, Van Meter said. “This is really the first time we’ve had bipartisan, bicameral legislation introduced, and that’s critical.”

Several stakeholders have played a role in the effort, including the patient community and other associations, Van Meter said. “We appreciate the leadership at the American Clinical Laboratory Association [ACLA],” she said, noting that the group has co-hosted a forum or two that addressed the predicament. “We may have some daylight between us on policy issues,” but the two associations share the goal of reform, Van Meter said, adding, “we think VALID is a great step in that direction.”

For his part, College of American Pathologists President Patrick Godbey said that any new framework “must leverage existing processes” to ensure quality tests without undue additional financial burdens. Godbey said this new version of the VALID Act is a “step in the right direction,” inasmuch as it eliminates much of the overlap between CLIA regulations and previous proposals regarding FDA regulation. He said the association would comment further in the weeks ahead.

Neither the ACLA nor the Association for Molecular Pathology was able to make a spokesperson available for comment.