Congress has been making noises about adopting legislation to impose order over FDA regulation of laboratory developed tests (LDTs) for nearly a decade. Last year, it almost happened when 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 Act 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, VALID appeared on its way to passage—not as a standalone bill but rather via inclusion 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. 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 much 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.
Of course, legislation may not be the only option. There are new signs suggesting that the FDA is prepared to use the federal rulemaking process to impose new LDT regulations. 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 would prefer to 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 annual meeting.
This may all just be posturing, perhaps designed to light a fire under Congress. One major problem is that 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 put to the challenge 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. 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.
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.
Meanwhile, the lab industry continues to dangle in the wind waiting for a fair, reasonable, and transparent set of regulations on developing new lab tests.
For the full version of this article, see our April 2023 issue of National Lab Reporter, posted in advance of PDF publication.