While the U.S. FDA’s final rule for regulation of lab-developed tests (LDTs) has yet to emerge, there is some reason to expect the rule will be met with litigation from clinical lab associations. The FDA’s Jeff Shuren said in remarks to this year’s meeting of the Medical Device Manufacturers Association that there is a legitimate problem with the accuracy of many LDTs, adding that while stakeholders are at liberty to question the FDA’s rulemaking, the agency’s experience in this area indicates that the question of LDT reliability is not up for debate.
The U.S. FDA’s pending final rule for regulation of lab-developed tests has proven unusually controversial even for the FDA, but Rep. Anna Eshoo (D-Calif.) stated in a March 21 hearing that congressional inaction has left the agency in an uncomfortable spot.
The U.S. FDA has commenced with a pilot program for companion diagnostics (CDx) for oncology therapies, which fulfills in part a 2014 agency guidance on the use of CDx. The FDA expects to enroll only nine reference drugs and the associated companion test, but the pilot program is part of the FDA’s controversial attempt to deal with lab-developed tests (LDTs), specifically those tests that are used to determine whether a patient is likely to respond to a particular oncology treatment.
As calendar year 2023 limps to the finish line, a number of important regulatory developments emerged and then submerged, but one development that is also a non-development took center stage in the world of med tech. The U.S. FDA has proposed a regulation for lab-developed tests (LDTs), an issue that has been simmering for the better part of a decade thanks in no small part to Congress’ failure to pass legislation that would eliminate the FDA’s controversial approach to rulemaking.
The U.S. FDA’s draft rule for lab-developed tests (LDTs) has proven to be every bit as controversial as expected, although the controversy is only marginally about the workload that would come with rulemaking.
The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was accorded a mere 60 days for comment, but nonetheless drew support from a number of stakeholders, including Foundation Medicine of Cambridge, Mass.
The U.S. FDA’s draft rulemaking for regulation of lab-developed tests (LDTs) came with a conspicuously short comment period of 60 days, but the agency is unresponsive to requests to add another 30 days to the comment period.
The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) carries an exceptionally ambitious timeline of completion and enactment by the time the next user fee agreement kicks in, and some see big problems with the timeline laid out by the agency. However, the FDA’s Elizabeth Hillebrenner said that Congress can tweak user fee legislation such that a specific set of user fee sources kicks in off schedule, thus giving the agency a little more leeway in completing any activity related to the proposed rule.
The U.S. FDA reported a pilot program for validation of lab-developed tests (LDTs) used as companion diagnostics, a move that seems an implicit recognition that test kits as CDx products are not the darlings of test developers. The program arrives as the agency is considering rulemaking for regulation of LDTs, however, a combination of developments that promises to roil the already strained relationship between the FDA and clinical labs.
A committee of the U.S. House of Representatives wrapped up business in a late-running June 14 markup of spending bills that would give the U.S. FDA roughly $6.6 billion to work with in fiscal 2024. However, the final bill omits language in the manager’s mark that had called on the FDA to engage in rulemaking or guidance development for lab-developed tests, but the FDA made up for that by adding a proposal to engage in rulemaking for LDTs in its regulatory agenda.