LDT Reform: If Congress Won’t Do It, We Will, Says FDA

One of the biggest stories in laboratory compliance in 2022 is what didn’t happen, namely, passage of new legislation to reform the FDA’s current regulation of laboratory developed tests (LDTs). While the same thing can be said of any other year since the dawn of recorded history, lack of LDT reform legislation was a big deal in 2022 because it almost happened. Hopes are high that something will finally be done to resolve the LDTs situation this year. However, that action might come not from Congress but the FDA itself. At least that’s the message the agency has been trying to send in recent weeks.

The VALID Act Near Miss

Congress has been playing around with LDT regulatory reform for nearly a decade. Last year, bipartisan lawmakers introduced a new version of a bill with an old name—VALID, short for Verifying Accurate, Leading-Edge IVCT Development Act. The new VALID would have dramatically overhauled FDA oversight of LDTs and in vitro clinical tests (IVCTs) by establishing a risk-based framework for their regulation.

Proposed in the spring of 2022, VALID appeared on its way to passage—not as a standalone bill but rather as part of a broader FDA reforms package in other must-pass legislation, first the MDUFA V bill authorizing continuation of the FDA’s medical device user fee program and later the end-of-year federal government funding bill.^1,2 In each case, VALID was cut out of the final version at the last minute.

With a new and divided Congress taking control, there’s not a whole lot of optimism that VALID or any other major piece of LDT reform legislation will again come as close to the finish line, let alone cross it, in the next two years.

If Congress Won’t Act, We Will, Says FDA

Of course, legislation may not be the only option. There’s also the possibility that the FDA will implement LDT reform in the form of new regulations. There are new signs suggesting that the agency is thinking along those lines. On March 1, the FDA’s Elizabeth Hillebrenner said that the agency considers the LDTs situation to be a serious public health problem. While the FDA says it would rather regulate LDTs under new legislation passed by Congress, Hillebrenner said the agency isn’t waiting around and that “we are moving forward with rulemaking.” The remarks, which were reported by BioWorld, came during the American Clinical Laboratory Association’s 2023 Annual Meeting.³

What Next for LDT Reform?

While it may sound like decisive action, the new noises coming from the FDA about taking the LDT reform bull by the horns may be more show than substance, perhaps designed to light a fire under Congress. For one thing, it’s far from clear that the FDA even has the legal authority to regulate LDTs or lab tests in general. The agency has long contended that regulating lab tests is an extension of its authority to regulate medical devices under the Food, Drug, and Cosmetic Act (FDCA). But that theory could be challenged in federal court were the agency to seek to implement LDT regulation on its own without a new legislative mandate from Congress. It’s unclear whether the agency would be willing to risk such a high-stakes legal fight.

On the other hand, the FDA has gone down this road before. In 2014, the agency published a pair of draft guidances setting out a proposed regulatory framework for LDTs.⁴ However, the reaction to the proposals was overwhelmingly negative. Critics inside and outside the laboratory industry contended that the FDA plan was unduly burdensome and would thwart innovation by driving up the costs and time necessary to develop new tests.

After the 2016 presidential election, the FDA announced that it was pulling the plug on the proposals and wouldn’t issue final guidance, choosing instead to leave LDT reform to Congress while supporting bills like VALID that would leave the agency in charge of regulating LDTs.⁵

Of course, none of this has prevented the FDA from continuing to regulate LDTs under its asserted authority under the FDCA. In addition to issuing safety communications warning against the use of certain unapproved LDTs, the agency regulated new LDTs for COVID-19 during the public health emergency.

Takeaway

If history is any indicator, FDA rulemaking may result in regulation that is highly burdensome. The lab industry and US population would be better served by legislation, which could even include legislation transferring oversight over LDTs from the FDA to the U.S. Department of Health & Human Services under CLIA. But for now, after the VALID Act near miss of last year, labs will continue to have to wait for an LDT regulatory resolution.

References:

1. https://www.g2intelligence.com/congress-passes-new-fda-medical-devices-user-fee-amendments-mdufa-v-deal/
2. https://www.g2intelligence.com/five-key-changes-affecting-labs-in-the-new-spending-bill/
3. https://www.bioworld.com/articles/694701-hillebrenner-says-fda-no-longer-waiting-on-congress-for-ldt-regulation?v=preview
4. https://www.g2intelligence.com/fda-plans-to-regulate-lab-developed-tests-could-increase-time-and-cost-of-development/
5. https://crsreports.congress.gov/product/pdf/IF/IF11389