Stakeholders continue push for VALID Act in wake of FDA’s proposed LDT rule

After the US Food and Drug Administration (FDA) published a proposed rule last week that would phase out the agency’s regulatory discretion policy for laboratory-developed tests (LDT), stakeholders said they are still hopeful for a legislative resolution to the issue.

For many years, FDA has tried to assert that it has the authority to regulate LDTs as in-vitro diagnostics (IVD) that are currently considered medical devices. At the same time, the agency has also pushed for Congress to pass the Verifying Accurate, Leading-edge IVCT Development (VALID) Act to create a new regulatory framework for IVDs that would be separate from medical devices. But despite coming close to passage in 2022, the legislation has yet to make it over the finish line.

With no progress on the legislative front, FDA published a proposed LDT rule on 29 September that it said would reassert its regulatory authority. However, the agency also signaled it is open to stakeholder input on which LDTs it should regulate and how that should be done (RELATED: FDA proposes long-awaited LDT enforcement rule, Regulatory Focus 29 September 2023)

Challenging FDA’s authority

The American Clinical Laboratories Association (ACLA) has long argued that FDA does not have the legal authority to regulate LDTs, but it is open to legislation that would create a new pathway for diagnostics products more broadly.

“We do not think that the FDA has the authority under current law to regulate LDTs as medical devices, and furthermore, we don't think that the medical device framework is well-suited for the regulation of diagnostics in general and LDTs in particular,” ACLA President Susan Van Meter told Focus. “We've long said that we can see a role for the FDA, but only if Congress steps in to develop, through legislation, a comprehensive regulatory framework that's diagnostic specific.”

“We did work in earnest on both sides of the aisle last year on the VALID Act,” she added. “We spent a lot of time discussing the provisions with the FDA.”

Van Meter said ACLA proposed provisions in the bill that were ultimately included, such as grandfathering certain products, allowing certain products to transition, a modification policy, and a technology certification (Tech Cert) program that gives FDA new authority. VALID, however, failed to be included in the 2023 Consolidated Appropriations Act as many had hoped and led FDA to ultimately propose the LDT rule (RELATED: US FDA sees boost in FY23 budget proposal but no diagnostic reform, Regulatory Focus 20 December 2022).

While ACLA is not taking a position on VALID at this time, Van Meter said they are still committed to working with lawmakers to develop it. If worded properly, it would be the right policy approach to develop a new framework giving patients access to LDT tests while still encouraging innovation, she said.

“When we think about the VALID Act or any other similar comprehensive legislation, it's not just about applying a regulatory apparatus to LDTs. It's about establishing, for the first time, the regulatory framework that's specific to diagnostics,” said Van Meter. “It is an imperfect regulatory framework for IVDs right now.”

Given the importance of diagnostics to the delivery of healthcare, there should be a diagnostic-specific regulatory framework, just like there is for drugs, she said. “The medical device framework is inappropriate for diagnostics. That standard of safety and effectiveness is not the right standard for diagnostics, which should be analytical and clinical validity,” she explained.

ACLA is also concerned that FDA doesn’t have the resources needed to regulate LDTs as outlined in the proposed rule. Van Meter said that the agency has repeatedly shown it has resource constraints, which creates concerns that attempting to regulate LDTs could create strain on the agency and harm its overall mission.

FDA’s proposed rule outlines instances when a test manufacturer would also be considered a laboratory, triggering the payment of medical device user fees if they submitted their product for premarket review. Van Meter, however, asserts that the agency’s rationale is flawed and that laboratories cannot be considered manufacturers in the first place.

A whole new framework

The medical device lobby group, AdvaMed, is still reviewing the proposed LDT rule and conferring with its members, but unlike ACLA, it has long held the position that FDA does have the necessary authority to regulate LDTs. However, the group is also hopeful that Congress will pass diagnostics reform legislation.

“Our position has always been that FDA needs regulatory reform in the diagnostic space, and the only way to get that would be for Congress to pass a bill like VALID,” Zach Rothstein, Executive Director for AdvaMedDx, AdvaMed’s diagnostics arm, told Focus. “We think VALID was a well-tailored approach to bring about the appropriate changes to the regulatory environment for diagnostic tests.”

Rothstein noted that VALID would not only address certain issues important for the LDT sector, such as ensuring patients continue to have access to tests while allowing for innovation, but it would more broadly allow IVDs to be updated and modified through the creation of the new Tech Cert pathway.

The Tech Cert program is envisioned to be similar to FDA’s software precertification (Pre-Cert) program, which was proposed a few years ago but never progressed beyond the pilot stage due to a lack of Congressional authority (RELATED: FDA acknowledges shortcomings of Pre-Cert pilot in report, Regulatory Focus 3 October 2022)

“Companies could go to FDA to be part of the Tech Cert program and have their product essentially reviewed once and allow for changes to occur after that initial review, as long as certain parameters are met that FDA and the companies have agreed to,” Rothstein said.

When Congress passed the 2023 Consolidated Appropriations Act last year, lawmakers did give FDA authority to allow products that include predetermined change control plans (PCCP) that in some cases could be used by IVD manufacturers to update their products, Rothstein noted.

“That would allow for a more limited approach to having tests updated without going back through FDA’s review process,” he added. “But it would not be at nearly the same level and depth as what the Tech Cert program would be able to achieve.”

Rothstein said he hopes that after Congress and the rest of the IVD community take a look at the proposed LDT rule, it will motivate them to get back to the table to pass the VALID Act.

“VALID has been a proposed law that's been highly vetted and highly discussed among the stakeholders,” Rothstein said. “It's now just a matter of Congress coming together to move it through its process so that it can become law.”

Rothstein said it is unlikely lawmakers will be able to pass the bill this year, but he is hopeful that it could pass in 2024.

Stakeholders continue push for VALID Act in wake of FDA’s proposed LDT rule

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