WASHINGTON — The Food and Drug Administration has always believed it has the power to regulate tests made in labs. But it was only under President Biden that it began actively exercising that authority, releasing a policy in April telling labs they have four years to comply with regulatory requirements.
It was a move that sought to restore patient confidence in test quality — and infuriated labs. But the Trump administration is likely to reverse the policy, experts tell STAT, plunging lab tests into a world of continued regulatory uncertainty and leaving patients who order tests online or receive them at the doctor’s office without the protections that come with FDA scrutiny.
“What everyone wants to see is a system where one can have confidence in these tests and not have to question whether they’ve been sufficiently evaluated or not,” said Jeff Allen, CEO of patient group Friends of Cancer Research. “Hopefully that won’t suffer as the policy and political discourse winds its way forward.”
When the FDA started regulating medical devices in 1976, lab tests were simple and given to local patient populations. Today, they’re far more complex and commercialized, with greater potential for patient harm via misdiagnosis. Yet labs argue that their tests are not medical devices as the FDA defines them, and should not be subject to regulation. Instead, they say their tests are “professional health care services.”
Congress tried to address the lab test regulation gap through various bills over the years. But when the most recent attempt failed in 2022, the FDA decided to take matters into its own hands this past spring.
The American Clinical Laboratory Association and the Association for Molecular Pathology each promptly sued the agency, claiming that only Congress can give the FDA this regulatory power. Their case may be helped by the Supreme Court’s recent reversal of the Chevron doctrine, a precedent giving federal agencies the power to interpret vague statutes.
The litigation already made the fate of the FDA’s lab-developed test (LDT) rule unclear. Trump’s win adds another layer of uncertainty. Given his bent toward deregulation, it’s likely that a Trump FDA will roll back the rule or at least stop actively defending the rule in court. Labs preparing for regulation may be able to reverse course.
FDA spokesperson James McKinney told STAT the agency cannot speculate on hypothetical situations or comment on active litigation.
Stakeholders in favor of LDT regulation, which include patient groups and traditional diagnostic makers who want their lab competitors to also face FDA regulation, are hopeful that Congress will take up the mantle and end this game of regulatory hot potato. But lobbyists are doubtful. No Senate Republican has been willing to champion legislation since the co-sponsor of the 2022 VALID Act, former Sen. Richard Burr (R-N.C.), retired in 2022.
What could happen to the FDA’s rule
The FDA’s lab test regulation is difficult — but possible — to roll back. Before repealing it, the Trump administration would need to publish its reasoning and seek public comment. That could take months.
Still, Trump has done it before. His Health and Human Services Department revoked the FDA’s authority to regulate lab tests during the Covid-19 pandemic. While his health care picks have not talked about the issue recently, at least one has criticized LDT regulation in the past. Deputy HHS secretary nominee Jim O’Neill said in a 2014 speech that he “put a stop” to the FDA regulating some companies with algorithm-based lab-developed tests when he worked at the agency in the early 2000s.
“The head of devices at FDA wanted to expand the sphere that FDA could regulate, and particularly start regulating blood tests that test for multiple things … a great example of this is 23andMe,” O’Neill said. “In order to regulate in this space, FDA had to argue that an algorithm, a series of numbers that match up to things, is a medical device. I found that really astonishing.”
Marty Makary, Trump’s pick for FDA commissioner, has written extensively about overdiagnosis and the harm false tests can cause. It’s unclear whether that background would lead him to defend the rule.
Jeff Shuren, longtime head of the FDA’s devices center and a driving force behind the rule, is retiring at the end of this year. His replacement, Michelle Tarver, will now have to take on the complicated issue.
Rolling the rule back, or neglecting to defend it in court, would be a popular move among labs, hospitals, and even some pro-regulation stakeholders who would prefer Congress create a separate LDT pathway.
“Many, if not most, organized clinical laboratory organizations would be OK with the rule being rolled back, even though that presents some of its own uncertainty,” said Jonathan Genzen, chief medical officer of ARUP Laboratories.
What could happen in Congress
Many industry lobbyists saw the 2022 VALID Act as the last chance for LDT legislation to be passed by Congress. So far, that prediction has come true. Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.) reintroduced the bill in the House last year, but it has languished.
Sen. Bill Cassidy (R-La.), who will chair the Senate’s health committee next year, has at least expressed interest in the issue. He lambasted the FDA’s rule when it came out, saying the agency does not have the authority to unilaterally regulate LDTs. He also requested information from stakeholders about LDT regulation in March. Cassidy’s office did not respond to a request for comment.
“While past legislative efforts may have missed the mark, it is time for Congress to assert itself and clarify FDA’s authority in the regulation of diagnostic tests,” Cassidy said.
“I inherited LDTs from Senator Hatch, and I partnered with Senator Bennet (D-Colo.),” Burr said. “Senator Bennet is still there. I think if there were an attempt by the agency to get stakeholders together, you could easily codify something in law.”
Others are skeptical that a Republican lawmaker will suddenly appear and become LDT regulation’s knight in shining armor — especially given the fact that it’s a wonky regulatory bill with political baggage. The issue is nuanced, with powerful industries on both sides. VALID failed, in part, because academic medical centers wanted a regulatory carve-out.
“It’s difficult to imagine that this is top of mind right out of the gate,” said Sheila Walcoff, CEO of diagnostic consulting firm Goldbug Strategies. “Everyone prefers a legislative approach, but the inability for the industry to maintain consensus on the scope of new laws is the ultimate poison pill. This has been happening for almost two decades. Everyone gets on board, then carve-outs collapse it at the end.”
Instead, lobbyists might suggest pulling out parts of VALID to create new legislation that makes FDA regulation more palatable to labs. Creating a more flexible regulatory pathway for diagnostics may be more appealing to Republicans than giving the FDA more authority. It wouldn’t give FDA the unilateral ability to weed out bad tests, but it could incentivize more labs to submit their tests for approval.
“There is a way to do this, and the incoming administration has already indicated willingness to create incentives as they did before,” Walcoff said. “It’s certainly very consistent with the Trump vision, this idea of smart common sense regulation as opposed to total deregulation.”
What’s happening in the meantime
Despite the chaos of litigation and a departing administration, labs are reluctantly preparing for regulation. The final rule is still in effect.
“We are starting to hear investors asking, ‘What’s your FDA compliance plan?’” Walcoff said. “Just saying the requirements are in litigation is not a plan. The world is in litigation. The rule is in force, so this is not something that can save you from not being compliant.”
Genzen said his organization is preparing for the FDA’s first regulatory deadline in May 2025, which requires labs to have systems in place for monitoring the safety and efficacy of tests already on the market. But they’re slowing down efforts to comply with more stringent regulations.
“I would say there’s a lot more caution in the community to wait and see what happens with litigation, the new administration, and the final rule,” Genzen said.
The FDA has held webinars and posted FAQs about LDT regulation, but the litigation limits what the agency can say about the rule. Labs are struggling to schedule meetings with agency officials.
“It’s a real challenge for these labs to understand how to comply, and just hearing people from FDA read a script on a webinar is not enough,” Walcoff said.
There’s also the chance that any information the FDA is offering now will be moot in six months. Allen hopes stakeholders won’t lose sight of a fact that all sides can agree on: Patients deserve vetted, safe, and effective tests, no matter who makes them.
Trump’s win puts future oversight of lab-made tests in jeopardy
