FDA not to extend LDT rule deadline

The US Food and Drug Administration (FDA) will not extend the comment period deadline for a proposed rule that would start phasing out its regulatory discretion of laboratory-developed tests (LDT).

Extending the comment period would have potentially delayed the implementation of the rule while giving Congress more time to pass diagnostic reform legislation. Stakeholders had expected FDA to extend the comment deadline, but on 31 October, the agency announced it would move forward with the original timeline.

“After considering the requests and other factors, including the extensive background of public comment on this topic and the public health benefits of proceeding expeditiously, the FDA has determined to proceed with the standard 60-day comment period,” the agency said in a statement on its website. “As stated in the notice of proposed rulemaking, comments on the proposed rule must be submitted to the docket by December 4, 2023, in accordance with the procedures described in the notice.”

There are nearly 1,000 comments on the public docket already, including several from key stakeholders asking the agency to extend the deadline.

One of those stakeholders is the American Clinical Laboratory Association (ACLA), which has argued that FDA does not have the legal authority to regulate LDTs, which is overseen by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA). The group instead supports legislative reform that would create a new pathway for in-vitro diagnostics (IVD).

ACLA said it plans to submit detailed comments that address the legal, policy, and economic justifications made by FDA in its proposed rule, but to do so, the group asserts it needs more time to issue a proper response.

“This proposal, if finalized, would fundamentally reshape the regulatory requirements that apply to a large, diverse, and critically important segment of our health care industry,” said ACLA in its request to extend the comment period by 60 days. “We are working expeditiously to review the material cited in the Agency’s preamble and preliminary economic impact analysis, as well as the references cited by the Agency. We are also considering how the rule would interface or overlap with existing oversight of laboratories at the state and federal levels.”

The medical device lobby group AdvaMed had expected FDA to delay the comment period by at least 30 days. Speaking to reporters during a press conference on 10 October at the 2023 MedTech Conference in Anaheim, CA, AdvaMed CEO Scott Whitaker predicted the rule wouldn’t go into effect until at least the new year.

“We like the rule,” Whitaker said during the press conference. “We’re still trying to look at it and better understand exactly what it means from a regulatory standpoint, but the bottom line is, as we’ve said before, this is really about making sure that there’s a level playing field when you’re talking about diagnostic tests and having everything go through a similar pathway.”

Whitaker added that he suspected the laboratory industry may bring lawsuits against FDA arguing the agency doesn’t have the authority to regulate LDTs, which could further delay implementation of the rule.

While ACLA continues to argue that FDA does not have the legal authority to regulate LDTs, Whitaker said he wants to team up with the lab group and other organizations to pass IVD reform legislation.

He bemoaned that Congress got so close to passing the Verifying Accurate, Leading-edge IVCT Development (VALID) Act in 2022, which would have created a new pathway for IVDs, but failed to do so, putting the agency on a path to propose the LDT rule. “It feels to me like [FDA does have the authority],” he said. “If you don’t think they have the regulatory authority, that’s fine. Then let’s join forces and get the VALID Act passed, and then we don’t have that question.”

But Whitaker argued that Congress is more incentivized than ever to pass VALID now. “I think the fact that FDA issued the [proposed] rule probably gives Congress more reason to [pass VALID] because in many ways, in Congress’s mind, [FDA] stepped over their area of responsibility,” Whitaker said.

The Medical Device User Fee Amendments (MDUFA VI) negotiations could be the vehicle to address whether IVDs should be regulated under a new pathway or if they should be allowed on the market under the current 510(k) pathway used for medical devices, he said.

“When Congress doesn’t do its work, it creates a lot more uncertainty in the marketplace around an issue like this and it’s not healthy for anyone,” Whitaker said. “The bottom line is, there really shouldn’t be multiple pathways for diagnostics to get to the market. There should be one way to do it.”

“Either you raise the regulatory standard, or you lower the regulatory standard, but you do it consistently across the board without stifling innovation,” he added.

The Academy of Clinical Laboratory Physicians and Scientists asked for an extension of the comment period deadline on behalf of almost 90 organizations, hospitals and clinical laboratories. Their letter argues that the rule has the potential to not only disrupt patient access to tests, but to prevent new tests from coming to market.

Organizations such as the American Red Cross and the American Hospital Association (AHA) also asked FDA to extend the comment period deadline to 2 February 2024 to give their members more time to evaluate the overall impact of the rule if it is finalized.

“The AHA is working closely with our hospital and health system members to assess the impact of the proposed rule on the critically important work they do in ensuring safe and effective diagnostic testing for patients,” the hospital group wrote. “Based on their initial feedback, we are concerned that the rule would have significant negative implications on patient access, clinical practice and innovation.”

The American College of Medical Genetics and Genomics went a step further, asking the agency to extend the comment period for 120 days. RAPS