Trump’s Second Term Could Turn LDT Regulation on its Head

The winding road of laboratory-developed test (LDT) regulations is likely to see another twist as the recent election of Donald Trump to a second US presidential term puts FDA’s final rule on the line. Based on his first presidency and more recent comments promising sweeping changes to FDA, the incoming administration may be inclined to show interest in the unpopular final rule, upending the changes in favor of potential alternatives or a return to previous regulation iterations.

What’s an LDT?

LDTs are in-vitro diagnostic tests intended for clinical use and designed, manufactured, and used within a single clinical laboratory which meets regulatory requirements. They are used in collection, preparation, and examination of specimens taken from the human body, like blood, saliva, or tissue.

“A LDT is a type of assay that is ordered by a physician and conducted on a biological specimen, such as bodily fluid or tissue samples, in a clinical laboratory using various equipment to process the specimen and analyze specific proteins, genetic material, or other biomarkers, typically for the purpose of aiding the diagnosis of a patient,” Benjamin Zegarelli, counsel at Mintz, previously told MD+DI. “Specifically, FDA defines an LDT as an in vitro diagnostic test, or IVD, that is designed, manufactured, and used within a single clinical laboratory licensed under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, to perform high complexity testing. Currently, there are LDTs for a broad range of intended uses, from measuring vitamin or mineral deficiencies to aiding the diagnosis of cancer or other life-threatening conditions.”

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Regulatory past

Initially, FDA implemented its authority to regulate LDTs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1976. Around that time, the agency also established an enforcement discretion policy because LDTs were seen as mostly low-complexity assays for single analytes and considered lower-risk.

“The enforcement discretion meant that the agency generally did not enforce applicable requirements to most LDTs,” according to a previous MD+DI article.

Then in 1988, LDTs were added to the Clinical Laboratory Improvement Amendments of 1988 standards (CLIA), which is overseen by the Centers for Medicare and Medicaid services and state agencies.

However, according to FDA, LDTs are no longer considered lower-risk, and are used more widely for larger and more diverse populations, rely on high-tech instrumentation and software, are tested in large numbers, and are more frequently used to guide critical medical decisions.

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Among other factors, like potential public health ramifications if these tests do not perform as well as its FDA-authorized counterparts, the agency ruled that greater oversight of the safety and effectiveness of LDTs was needed, hence the implementation of the final rule earlier this year.

LDT final rule

Under the final rule, LDTs are officially regulated as medical devices and clinical laboratories are responsible for compliance with FDA, CLIA, and relevant state regulations relating to their facilities and tests. The new increased requirements include premarket review, quality system requirements, adverse event reporting, establishment registration and device listing, labeling requirements, and investigational use requirements.

More information on the LDT final rule can be found here.

However, the blowback from the updated requirements were swift, with some fearing burdensome and expensive changes to clinical operations, leading to lower revenues as labs implement new quality systems and obtain marketing authorization for moderate- and high-risk assays. Additionally, separate authorization for many types of modifications to devices will also be required, adding additional constraints on laboratory flexibility to adapt assays to differing customer needs, such as adding specimen types, accommodating different lab equipment, or multiplexing in new biomarker detections.

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A whirlpool of possibilities

While, at the time, it may have seemed the fight was over with FDA coming out victorious, the election of Trump to his second term has introduced a curveball many didn’t see coming.

Even before President-Elect Trump was officially named the next occupant of the oval office, lobbyists representing medical lab groups had reportedly been in contact with both presidential campaigns to discuss softening LDT regulations, according to Today’s Clinical Lab.

And based on his track record, Trump may be the most likely person to do so.

“The likelihood that the new Trump administration will take action to eliminate FDA's final rule to phase out enforcement discretion for LDTs is relatively high,” Zegarelli recently told MD+DI. “However, the timing of any such action is uncertain. Various members of Congress and people associated with forming the president-elect's administration have suggested a number of potential reforms at FDA, so addressing the LDT rule may not be the highest priority.”

Back in 2020 during his first term, the Trump administration enacted a policy in which FDA no longer regulated LDTs, with the Department of Health and Human Services (HHS) writing at the time, “the department has determined FDA will not require premarket review of laboratory-developed tests absent notice-and-comment rulemaking, as opposed to through guidance documents, compliance manuals, website statements, or other informal issuances.”

This policy, it must be noted, was put in place during the beginning of the COVID-19 pandemic when the US and world were in dire need of emergency use authorized (EUA) COVID-19 tests.

Image courtesy of Benjamin Zegarelli, graphic courtesy of MD+DI.

“It is highly likely that the new administration will revive the previous Trump administration’s position (as expressed in a memorandum authored by the HHS General Counsel, Robert Charrow, in June 2020) that FDA lacks the statutory authority to regulate LDTs and use it as justification to halt implementation of the final rule,” Zegarelli said. “Charrow prepared that memorandum during the pandemic, however, and much of the government's attention was focused on increasing the nation's diagnostic testing supplies and capabilities, so it's possible that LDTs become a lower priority for the incoming Trump administration without the exigency of the pandemic.”

Now post-COVID, these policies have since changed, most notably with the FDA’s final rule.

But with the rule firmly in place, the incoming administration may have multiple avenues to stop it in its tracks.

The courts

The courts could be one of the ways the administration changes LDT legislation, and it, surprisingly, could come through inaction.

After FDA issued its LDT rule in early 2024, the American Clinical Laboratory Association (ACLA) responded by filed a lawsuit against the agency in the United States District Court for the Eastern District of Texas. The association said at the time that FDA “inappropriately seeks to regulate professional laboratory testing services as medical devices under the [FD&C Act].”

“In ACLA’s complaint, the association — which was joined by HealthTrackRX, and endorsed by testing providers such as Labcorp and Quest Diagnostics — wrote that LDTs are not individual products, but services, meaning that they are outside of FDA jurisdiction,” according to a previous MD+DI article. “The trade group said that interpreting and delivering diagnostic results are based on the professional judgement of a trained lab worker.”

The Association for Molecular Pathology (AMP) also later filed its own suit, which was later combined with ACLA’s in September.

With the summary judgement in the ACLA/AMP case expected in early 2025, its outcome could close the curtains on FDA’s LDT regulatory oversight.

Christine Bump, a healthcare regulatory attorney, wrote on LinkedIn on Nov. 6, “Summary judgment in the ACLA/AMP suits is expected in early 2025, probably February. If ACLA/AMP prevail, a Trump FDA is not likely to appeal that ruling. If FDA prevails, a Trump FDA would probably not enforce the Stage 1 deadline of the final rule, and could be prompted to act on the issue more broadly.”

With several stages of compliance in the future, the first LDT final rule stage begins on May 6, 2025.

However, according to Zegarelli, the courts aren’t the most likely avenue to upend the rule.

“The path the Trump administration would ultimately take to quash the final rule will depend on the extent to which the issue is a high priority,” he said. “It’s unlikely that the administration would let the ACLA/AMP lawsuit play out and leave the decision to the courts, in no small part because any final decision on FDA's authority to regulate LDTs would take years and may result in the courts upholding the agency's purported authority. It’s therefore possible that the Trump administration’s DOJ will stop defending the FDA’s action within the context of the consolidated lawsuit and/or seek to settle it in an expedited fashion by making certain concessions to the plaintiffs.”

Back to Congress

Another scenario comes in the form of Congress. With Trump coming into his second term with control of the Senate and presumed control of the House of Representatives, the administration could work to quickly pass a new version of the Verifying Accurate Leading-Edge IVCT Development (VALID) Act, which was introduced in 2020 and stalled on the floor after the bill was seen as antagonistic by the industry.

“With respect to the VALID Act, it seems likely that Congress will renew consideration of the bill in the next year or two,” Zegarelli told MD+DI. “The VALID Act appears to enjoy bipartisan support. Members on both sides of Congress have recognized the potential risks associated with an under-regulated diagnostic testing industry, while complaining that FDA's unilateral rulemaking is not the best method to address such risks, but there were many other political logjams in recent years that forced its consideration to the side. If Congress renews consideration of the VALID Act in its next session, it would not preclude action by the Trump administration to eliminate the final rule. It would be much more likely for those processes to proceed concurrently.”

With FDA’s LDT final rule casting a hefty shadow, laboratory professionals may view the act as the lesser of two evils. Through the act, labs would have more of a say in future LDT requirements and could engage with lawmakers. The FDA file rule, on the other hand, is broadly seen by the industry as unilateral rulemaking by FDA issued without a vote.

“Almost all stakeholders appear to believe that the VALID Act is a better option, even FDA,” he said. “The main issue with FDA's final rule is that the authority to regulate clinical laboratories and the diagnostic tests they develop in house is not clearly delegated to FDA in the Federal Food, Drug, and Cosmetic Act. FDA certainly laid out its detailed reasoning supporting its authority in the preamble to the final rule and in its responses to submitted comments, but ultimately there is no explicit delegation of authority relating to clinical laboratories or LDTs in the Act. The VALID Act would change that by granting FDA clear authority over all ‘in vitro clinical tests,’ and that new terminology would be defined to include IVDs from traditional device manufacturers as well as LDTs from clinical laboratories. In addition, the legislative process allows all stakeholders to participate in the drafting of the ultimate statute, and that process was already fairly far along when FDA published its final rule, which in part led to the outcry from clinical laboratory stakeholders when FDA initiated the rulemaking process.”

Rescinding the LDT rule outright

This avenue seems the most unlikely. Trump, given his history of claiming vast executive power, some experts say, could invoke an executive order to repeal the LDT rule, though it seems legally murky, or even outright farfetched. The more likely approach would involve Trumps to-be-named FDA commissioner, or secretary of HHS, but even this would likely be met with strong industry resistance, according to Zegarelli.

“If the Trump administration simply eliminates the final rule based on the reasoning that FDA does not have sufficient authority to regulate LDTs, it likely wouldn't have a broader effect on the agency's other medical device regulations,” he said. “FDA has been exercising enforcement discretion with respect to LDTs while fully enforcing device regulations for other IVDs for decades, so halting implementation of the final rule would essentially return the regulatory landscape to the status quo before the rule became effective in July 2024. It is possible that the new secretary of HHS or the new FDA commissioner may attempt to go further to limit FDA's authority over diagnostic tests and related products, but such action would likely engender substantial resistance from the IVD industry as device manufacturers rely on agency regulations to establish high quality standards, creating a significant barrier to entry and ensuring that low-quality manufacturers cannot saturate the market.”

As for the future, the lab industry may be sailing stormy seas for the next few years while the regulatory world fights in the clouds.

Representatives from ACLA declined MD+DI’s request for comment.