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FDA Moving Quickly on LDT Rulemaking as 2024 Elections, 2027 User Fee Renewal Loom


NEW YORK – The US Food and Drug Administration appears determined to move quickly on its proposed rule covering regulation of laboratory-developed tests (LDTs).

The agency has rebuffed calls from various stakeholders to extend its public comment period, prompting some observers to suggest it is hurrying to get the rule on the books both to prevent it from being undone by a change in administration and to keep its implementation aligned with the next renewal of the Medical Device User Fee Amendments in 2027.

That speedy approach could have drawbacks, though, according to Allyson Mullen, a director at law firm Hyman, Phelps & McNamara, who said the agency's decision not to extend the comment period could provide opponents of the rule the basis for a legal challenge.

The FDA released its proposed rule for the oversight of laboratory-developed tests at the beginning of October and said at that time that the rule would be open for public comments for 60 days until Dec. 4. A number of lab industry groups requested that the FDA extend the comment period, including 89 organizations that issued an Oct. 31 letter to the agency requesting it open it for an additional 60 days.

The FDA, however, has held firm on the original 60-day deadline. During an agency presentation detailing the proposed rule, Elizabeth Hillebrenner, associate director for scientific and regulatory programs in the office of the center director within the Center for Devices and Radiological Health, said that given "the extensive background of public comment on this topic and the public health benefits of proceeding expeditiously," the agency would be keeping to "the standard 60-day comment period."

Sixty days is a common length for rulemaking comment periods, with, for instance, the Federal Register's Guide to the Rulemaking Process, noting that, "in general, agencies will specify a comment period ranging from 30 days to 60 days." The guide also notes, however, that "for more complex rulemaking, agencies may provide for longer time periods, such as 180 days or more." It is not uncommon for the FDA to extend comment periods in response to stakeholder requests. In August, for instance, the agency added 30 days to an original 60-day comment period for a proposed rule on tobacco product manufacturing. Last year, for a proposed rule on updating the definition of "healthy" on food labels, it extended an initial 90-day comment period by 50 days.

The FDA's proposed rule on LDTs is widely expected to face legal challenges, and Mullen said that one tack opponents might take is to argue that "the comment period didn't give [stakeholders] a meaningful opportunity to comment."

"It does seem the agency is moving at a rather rapid clip," said Susan Van Meter, president of the American Clinical Laboratory Association, which opposes the FDA's rulemaking efforts around LDTs and has for years maintained that the agency does not have legal authority to regulate these tests.

Mullen said she is aware of at least one case in which courts invalidated a regulator's rulemaking efforts due to an insufficient public comment period — a 2012 dispute between the US Department of Labor and agriculture employers over the suspension in 2009 of a 2008 rule governing the employment of temporary workers. While the 2008 rule underwent a 60-day comment period during which roughly 11,000 comments were submitted, the 2009 suspension underwent only a 10-day comment period in which roughly 800 comments were submitted. A district court ruled that given this short comment period, the DOL had not complied with notice and comment rulemaking requirements in the 2009 suspension, a decision that was upheld upon appeal.

James Boiani, an IVD, drug, and medical device life sciences attorney at Epstein, Becker & Green in Washington, D.C., said that it is "certainly possible that there will be challenges that weave in the expediency as an explanation for why any final rule should be invalidated."

Boiani suggested that such an argument around expedience would more likely come into play in disputes around particular details of the rule as opposed to the broader question of whether the FDA has the authority to regulate LDTs under the medical device framework it uses for in vitro diagnostics, which, he noted, has been thoroughly discussed over the last several decades.

"FDA can point to years and years of statements, advisories, warning letters, etc., that have consistently asserted that fundamental position," Boiani said.

As for why the agency is moving quickly on LDT rulemaking despite stakeholder requests for more time, Boiani said he thinks the looming 2024 elections are "undoubtedly" a driver. He noted that the election of President Donald Trump in 2016 effectively ended the FDA's efforts to regulate LDTs by guidance, and that given this history, the agency "will want to get this in the [Code of Federal Regulations] before November of next year."

Mullen noted that the agency may want to get the final rule on the books even before that to protect against repeal via the Congressional Review Act (CRA), which allows Congress to overturn rules enacted by federal agencies within 60 legislative session days after Congress receives the rule. Given that Congress is typically in session around 150 days a year, this could mean having a final rule in place as early as May or June 2024, she said.

The likeliest scenario for the CRA to come into play would be for Republicans to win the presidency and control of the Senate while maintaining control of the House. Originally passed in 1996, the CRA was used only once prior to the 115th Congress, which used it 16 times to repeal rules finalized in the late days of the Obama administration.

Boiani said the agency is likely also trying to time finalization of the rule and its subsequent implementation to the renewal of the Medical Device User Fee Amendments (MDUFA) in 2027. In the proposed rule, the FDA noted that its timeline, under which it would begin requiring premarket review of high-risk LDTs 3.5 years after publishing the final rule is "intended to align … with the beginning of a new user fee cycle."

MDUFA negotiations are typically a venue for the FDA to secure the resources needed to carry out its regulatory responsibilities while also establishing its obligations to industry in terms of items like review timelines.

The FDA said in the proposed rule that aligning the rule's implementation with MDUFA renewal "would provide an opportunity for industry participation in negotiations regarding the next user fee cycle with the knowledge that laboratory manufacturers would be expected to comply with premarket review requirements."

The current user fee cycle ends Sept. 30, 2027. Given the planned 3.5-year timeline for the FDA's LDT rule, the agency would need to have a final rule in place by the end of March 2024 in order to time full implementation of the rule to the next MDUFA cycle, a timeline that Mullen said "would be warp speed from FDA's perspective."

She noted that the fact that the FDA has been working on LDT regulation for years may enable a speedier than typical timeline, but added that it raises questions as to the extent to which the agency will engage with public comments.

"If they do move forward on that fast a timeline, how much consideration will they really give to the comments they receive?" she said. "It just seems very, very fast."

Asked by 360Dx about its decision not to extend the comment period, the FDA pointed to Hillebrenner's previous statement citing the "extensive background of public comment" on the topic and the "public health benefits of proceeding expeditiously."

As of the afternoon of Nov. 14, the proposed rule had received 1,779 comments.