FDA Official Defends Plan to Issue Guidance for LDTs

Jeffrey Shuren, director of the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH), this week defended the agency’s plans to issue draft guidance on laboratory-developed tests (LDTs). A Sept. 9 hearing of the House Energy and Commerce Health Subcommittee regarding the FDA’s intention to issue draft guidance on LDTs turned somewhat testy, as some Republican members accused the FDA of trying to sidestep the formal rulemaking process. Shuren faced questions from several Republican members about the FDA’s intention to release draft guidance that will describe the agency’s plans to oversee and regulate diagnostic tests manufactured by clinical laboratories and medical device companies. Rep. Michael C. Burgess (R-Texas), along with other members of his party, asked Shuren if the FDA held the authority to now propose new LDT regulations without going through the formal rulemaking process. Shuren said that the changes proposed to the LDT regulations don’t require the agency to follow the formal rulemaking process and that the FDA will release the draft guidance within 30 days. Shuren Defends Guidance Shuren spent a large part of his testimony defending the agency’s decision to issue guidance instead of a formal rule. While questioning Shuren, Rep. Joe Pitts (R-Pa.), the Health Subcommittee chairman, said the guidance marks a significant change of policy regarding LDTs and asked the CDRH director why the agency didn’t need to follow the Administrative Procedure Act when it announced its intention to regulate tests made by clinical laboratories. According to Shuren’s testimony, all diagnostic tests have been subject to FDA regulation since the passage of the Medical Device Amendments in 1976. However, Shuren said that since 1976, the agency exercised “enforcement discretion” of LDTs—that is, the FDA generally didn’t enforce applicable requirements for the tests—as they were limited in number, were relatively simple tests, and typically were used to diagnose rare diseases and uncommon conditions. Shuren testified that the agency doesn’t need to complete formal rulemaking because the FDA is only changing its enforcement policies for LDTs. Several subcommittee members of both political parties asked Shuren to comment on the guidance’s potential to discourage investment in diagnostic tests. Shuren responded that the FDA will continue to use its enforcement discretion and will only regulate tests that carry the highest risk. In written testimony, Shuren said, “FDA intends to continue to exercise enforcement discretion for many LDTs—including those that are low risk, for rare diseases, and for unmet medical needs,” adding, “Our upcoming proposal would incentivize innovation, and would also support the advancement of personalized medicine by assuring that patients and their physicians can rely on LDT results for making major medical decisions.”