Experts expect opponents of LDT rule to ramp up Congressional lobbying

Washington – Opponents of the US Food and Drug Administration’s (FDA) proposed rule to regulate laboratory-developed tests (LDT) are likely going to ramp up their lobbying of Congress to prevent the rule from being finalized, according to experts. If the rule is finalized, they will likely try to stop or stall the rule through litigation.

The comment period for FDA’s proposed rule to phase out its policy of enforcement discretion related to LDTs closed on 4 December. So far, the agency says it has received more than 6,700 comments, though it has only posted fewer than 4,000 of those comments to the public docket, and only 500 of those comments are viewable at the time of writing.

Supporters of the rule argue that FDA needs to regulate LDTs, especially in situations where test results are a matter of life and death, and to level the regulatory playing field between the labs that develop such tests and traditional in vitro diagnostics (IVD) manufacturers. On the other side, labs and their supporters continue to argue that the agency doesn’t have the legal authority to regulate the tests and that doing so would hurt patient access.

A panel of experts discussed the matter at the Food and Drug Law Institute’s (FDLI) Enforcement, Litigation, and Compliance Conference on 7 December in Washington, DC. They noted that both sides of the issue had coalesced behind the Verifying Accurate, Leading-edge IVCT Development (VALID) Act last year, which ultimately failed to pass. Following the inability to find a legislative solution, FDA published the proposed LDT rule that the experts said has moved both sides further apart.

Shannon Bennett, director of regulatory affairs at the Mayo Clinic, said that when the VALID Act didn’t pass, some labs felt like they had won the political battle, but they soon realized the rule would be worse for them.

“I do think there's a degree of shell shock right now with a lot of laboratories,” he said. “[The proposed rule] is VALID and then some.”

Carly McWilliams, head of North America regulatory policy at Roche and a former Congressional staffer, said that opponents of the rule are still advocating for a legislative fix and modernization of the Clinical Laboratory Improvement Amendments (CLIA). She noted that the Centers for Medicare and Medicaid Services (CMS), which is responsible for CLIA certification, is not interested in the changes opponents are asking for, and FDA sees CLIA as complementary to its regulatory oversight.

“I don't feel like the administration is going to change that position, so I don't know how productive or fruitful any of the conversations can be,” said McWilliams. “I feel like many stakeholders just want to pursue litigation until they can no longer do that.”

Margaret Martin, a policy advisor at DLA Piper and another former Congressional staffer, said that while the committees of jurisdiction in Congress have shown interest in the topic, they haven’t scheduled any hearings since the rule was proposed to try to push for legislation. She argued that as FDA gets closer to finalizing the rule and a timeline is set out for how it will be implemented, that may spur Congress to act.

Bennett suspects there will be a significant ramping up by the lab industry into the new year to lobby Congress to prevent the proposed rule from going into effect, but he also noted that the industry is not unified about what needs to happen.

“I think we're all pretty unified that device regulations are bad, but there are a lot of labs that think CLIA modernization is the way to go, and there are others that recognize that's unlikely to happen,” he said.

As FDA works to finalize the LDT rule, some stakeholders have asked the agency to take a risk-based approach by making exceptions for low- and moderate-risk LDTs and grandfathering some tests so they are exempt from the rule.

McWilliams, who is especially concerned about how the rule could affect rare disease LDTs, said grandfathering may pose its own problems as some tests would not be able to update themselves without coming under FDA oversight if they are grandfathered. She said she hopes the agency provides more information on how the rule could be implemented and noted that some stakeholders have suggested that FDA first require registration and listing of LDTs so they have a better idea of how many tests need to be reviewed so they can properly allocate resources.

“They need to have some pragmatic approaches to grandfathering to make sure that they can handle the workload,” McWilliams added.

Mahnu Davar, partner at Arnold & Porter, said taking a risk-based approach is critical, but also noted the current risk stratification system used for devices isn’t sufficient for LDTs. He also said that it’s likely that the majority of LDTs don’t have predicate tests, which will make it harder when submitting their products to the agency.

Moderator Stacy Cline Amin, a partner at Morrison and Foerster and FDA’s former chief counsel, said that one of the complaints levied against FDA is that it does not have the resources it needs to implement the proposed rule and noted that the timing seems to be lining up with the start of the next round of the Medical Device User Fee Amendments (MDUFA) negotiations.

McWilliams noted that VALID did include additional funding for LDT reviews, but now it will take three and a half years after the rule is finalized for FDA to ask for additional resources through MDUFA fees. However, how those negotiations play out is very uncertain.

“I think one of the big outstanding questions is, does the [lab] industry actually sit down with the agency, particularly if they've sued over the final [rule],” said Martin. “All of it is predicated on what the final rule looks like and how do the potential legal suits play out.”

Experts expect opponents of LDT rule to ramp up Congressional lobbying

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