Will President-Elect Donald Trump Change the FDA’s LDT Final Rule?

The election of Donald Trump to another term as US president has piqued interest among clinical laboratory leaders about the future of the FDA’s final rule on laboratory-developed test (LDT) regulations.

It’s not clear yet whether potential anti-regulatory policies under the Trump Administration will lead to LDT changes. However, it is reasonable to speculate—based on his first presidency and more recent factors—that the U.S. Food and Drug Administration’s unpopular LDT final rule may garner attention from the new administration at some point.

A source previously indicated to Today’s Clinical Lab that lobbyists representing medical lab groups had been in contact with both presidential campaigns to float the idea of softening LDT regulations. To be clear, the lab industry’s unhappiness with the FDA’s current final rule is not among the top priorities for the incoming Trump transition team, which is fielding hundreds of requests for various interests across all of business.

Court decision could influence FDA in 2025

The most likely chance for Trump LDT changes may come in the courts—and ironically, those changes may result through inaction. 

Let’s set the stage: After the FDA issued its LDT rule earlier this year, the American Clinical Laboratory Association (ACLA) filed suit, claiming that the agency lacked the authority to regulate LDTs. The Association for Molecular Pathology (AMP) later filed its own suit, and those actions were combined in September. Other industry groups have filed briefs supporting the lawsuit.

There have been several minor hearings on the matter, but healthcare lawyers have their eyes on early 2025, when a more significant summary judgment hearing is expected in U.S. District Court Eastern District of Texas. A summary judgment refers to a request, in this case from both parties, for the judge to issue a decision without a trial.

“Summary judgment in the ACLA/AMP suits is expected in early 2025, probably February,” wrote healthcare regulatory attorney Christine Bump on LinkedIn on November 6, after Trump had been declared the winner of the 2024 presidential election. “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.”

The LDT final rule has several stages of compliance, the first one beginning on May 6, 2025.

Do LDT changes go back to Congress?

Another scenario is that the membership of the retooled U.S. Senate and House of Representatives—perhaps eager to send bipartisan-supported legislation through in the early stages of Trump’s presidency—work quickly to pass a new version of the VALID Act. 

Formally called the Verifying Accurate Leading-edge IVCT Development Act, the VALID Act was originally introduced in 2020 and seen as antagonistic by the lab industry. In fact, academic medical center laboratories used their heft to restrain federal lawmakers, which largely led to the VALID Act stalling in Congress.

However, in the new shadow cast by the FDA’s LDT final rule, laboratory professionals may view the VALID Act as a better alternative. Labs would also have more of a say in future LDT requirements by engaging with lawmakers, as opposed to the LDT regulations that FDA officials issued without a vote.

It is important to note that LDT regulation is not truly a polarized issue. More aggressive LDT oversight has been brewing at FDA headquarters for more than a decade under multiple presidential administrations and FDA leaders. The VALID Act has also drawn bipartisan support, so any Trump LDT changes might have political appeal.

Trump rescinding LDT rule seems unlikely

Some long-time readers may remember OSHA’s ergonomics standard, which was released in late 2000 just as President Bill Clinton was getting ready to end his term. The standard—which imposed a series of ergonomics mandates for workers—went into effect on January 16, 2001. However, on March 20, 2001, his successor, President George W. Bush, signed a congressional bill to rescind the standard.

A similar situation cannot happen with the LDT final rule, at least on the surface. In 2001, lawmakers used the Congressional Review Act, which allows Congress to issue a fast-track disapproval of a rule within 60 days of that regulation taking effect. A new session of Congress had that window of opportunity with the ergonomics standard’s timing.

The LDT final rule went into effect on May 6, 2024—too many months ahead of Trump’s new term for the Congressional Review Act to apply. 

Could Trump try to use an executive order to repeal the LDT rule? Possibly, given his history of claiming vast executive powers, although it’s legally a murky approach. It seems more likely that if Trump wants to achieve that goal, he will simply direct his to-be-named FDA commissioner to pursue the matter.

Lab managers, pathologists, and bench scientists with an interest in the future of laboratory-developed test regulations should pay attention over the next few months to get a feel for whether any potential Trump LDT changes will occur.

Looking for more guidance about how federal laws will affect your clinical lab in 2025? Join our sibling brand, G2 Intelligence, for its free, virtual Lab Institute on November 13 and 14.