FDA on Laboratory-Developed Tests: No New Guidance?

The Food and Drug Administration for some time has been advocating for increased oversight of lab-developed tests, issuing guidance several years ago to phase-in a framework in which highest-risk tests would require premarket approval. 

Yet, as Kimberly Scott’s article explains in January’s Clinical Laboratory News, the GOP’s recent takeover of executive and legislative branches of government has carved a more uncertain path for the issuance of this guidance. Shortly after the 2016 November election, the agency decided to put its final guidance document on hold, announcing that it would consider “a risk-based approach in the near future.” 

AACC and other advocacy groups have opposed the idea of providing FDA with new oversight powers, instead calling for updates to the Clinical Laboratory Improvement Amendments (CLIA) to strengthen LDT regulation. As Scott’s article emphasizes, laboratories would have spent millions on premarket approval applications. And, according to experts, labs under FDA’s proposal would have had to create two very different quality systems for running tests and reporting results and designing and manufacturing the tests. 

Given the new atmosphere in Washington, and the Trump administration’s goal to tamp down on regulation, some predict that Congress will turn its attention to higher profile issues,  such as repealing and replacing the Affordable Care Act. 

FDA still has the means to regulate laboratories. This includes “sending out public notices challenging specific tests—as it did in September 2016 for ovarian cancer screening—or asserting that a particular test is not an LDT, or that a test is a direct-to-consumer test and therefore not subject to enforcement discretion,” Jeff Gibbs, an attorney with Hyman, Phelps & McNamara in Washington, D.C. and a contributor to the FDA Law Blog, told CLN. 

It is possible that FDA may decide to focus on the actions of specific labs rather than pursue guidance on a broader scale, Gibbs suggested. In any case, some laboratories have been bracing for increased oversight for several years now. 

Salt Lake City-based ARUP Laboratories, for example, did an overhaul of its implementation and test development processes to put them more in line with FDA’s quality system regulation (QSR), which in vitro diagnostic (IVD) manufacturers must follow. 

Meeting the challenges of QSR wasn’t easy, but even with the final FDA guidance on hold, David Grenache, PhD, medical director of the chemistry division at ARUP Laboratories, believes the changes were a worthwhile investment. “We improved the overall quality of our assay development and validation processes, documentation, and accountability,” he told CLN. 

Pick up the January issue of CLN and read about how other labs have responded to the prospect of increased regulation, as well as AACC’s plans to work with federal officials in wake of FDA’s decision to delay its guidance.