The Food and Drug Administration’s (FDA’s) assertion that it should regulate laboratory-developed tests (LDTs) has led to intense debates on Capitol Hill.

As the agency finalizes plans to issue guidance on LDT oversight probably later this year, Kimberly Scott in the April issue of CLN outlines the possible outcomes of this measure and describes the alternative proposals being drafted by lawmakers and industry groups, including AACC.

FDA’s draft guidance “would implement a risk-based, phased-in approach for oversight of high- and moderate-risk LDTs. It would continue to use enforcement discretion for low-risk LDTs, as well as certain categories of moderate- and high-risk LDTs,” Scott’s article explained. The agency asserts that too many LDTs are causing patient harm and that stepped-up regulation of these tests is sorely needed. A report the agency issued last fall detailed 20 case studies that cited problems with the tests. Yet, critics say FDA’s claims are flawed.

“I question the premise that there is a problem with LDTs,” James Nichols PhD, professor of pathology, microbiology, and immunology, and medical director for clinical chemistry and point-of-care testing at Vanderbilt University School of Medicine in Nashville, told CLN. “I don’t think the issue is with the tests themselves, but perhaps with communication and interpretations of the test results. That’s not something the FDA guidance would solve.” 

As CLN Stat reported in December 2015, AACC and other lab industry groups advocate that Congress should work within the existing CLIA framework to enhance CMS’s role in ensuring the accuracy of LDTs—rather than afford new responsibilities to the FDA. The concern is that creating a dual framework of CMS/FDA oversight would burden hospitals and rural facilities to the point that they would stop conducting these tests.

No matter what agency ends up with LDT regulatory authority, Scott’s article emphasizes that both CMS and FDA face resource challenges in ensuring the clinical validity of these tests.

Jeff Gibbs, an attorney with Hyman, Phelps and McNamara, PC, in Washington, D.C., and a contributor to the FDA Law Blog, says FDA could face a legal challenge under the Administrative Procedure Act once it issues its guidance. “The argument is that the FDA cannot make these kinds of changes through a guidance document, but instead needs to go through a rulemaking process,” Gibbs told CLN.

Pick up the April issue of CLN and learn more about the future of LDT regulation and what sort of impact the upcoming presidential election could have on FDA’s LDT guidance.