For more than 3 years, the lab community has endured an uncomfortable and uncertain limbo around potential U.S. Food and Drug Administration (FDA) regulation of lab-developed tests (LDTs). Now, an unusually candid presentation by Alberto Gutierrez, PhD, director of FDA's Office of In Vitro Diagnostics and Radiological Health at the 2013 AACC Annual Meeting in Houston is raising new questions about how—and if ever—FDA will move on LDTs and release a long-awaited draft guidance.

According to Gutierrez, an increase in lobbying by groups such as the American Clinical Laboratory Association has stalled progress on the draft guidance and changed the tone of FDA's previously open discussions with stakeholders. "At one time I thought the agency could put a proposal on the table, and we could have a discussion," Gutierrez said. "Three years later, I can tell you only that I can't tell you that it's not going to happen; I can't tell you that it's going to happen—it's out of my hands. I have no idea whether the agency will be able to put together a proposal for this or not." Gutierrez spoke during the AACC/ASCLS Healthcare Forum, an annual symposium at the AACC Annual Meeting.

When FDA announced its intention to begin regulating LDTs in 2010, many laboratorians feared a burdensome and costly new layer of regulation on essential tests they had developed or modified in-house for years.

AACC Annual Meeting attendees at healthcare forum.
AACC Annual Meeting attendees came to the annual
AACC/ASCLS Healthcare Forum to hear updates on regulatory and policy issues.

In fact, the agency had intended to release a draft guidance as early as 2011, but it got stalled after the issue became politicized, according to Gutierrez. In 2012, those opposed to LDT regulation convinced Congress to pass a law that requires FDA to give Congress 60 days' notice before issuing a draft guidance on LDTs. "It seems to me that the only reason Congress wants to know 60 days before is because they have lobbyists who want to prevent the guidance from coming out," Gutierrez said. "Therefore, the discussion that we meant to have is not likely to happen. We've started a new era where the discussion has become political."

Gutierrez also made the case that, despite a slow and politicized process, LDT regulation is still needed. He offered several recent examples of problems, including the ongoing use of the BD SurePath test for human papillomavirus (HPV) screening. This test is FDA-approved only for Pap testing, and the agency warned labs in June that using SurePath for HPV screening could produce false-negative results.

He went on to highlight how the FDA and LDT regulatory pathways have been competing in the marketplace. In one case, not long after the agency in 2011 approved the Roche Diagnostics BRAF mutation test kit for labs, another company announced it would offer the test as an LDT, avoiding the FDA clearance or approval pathway.

At the same time that he lamented a process mired in politics, Gutierrez hinted that leaving the LDT issue up for grabs could be perilous, both for patients and for the lab community. He invoked the problems with compounding pharmacies in 2012 where unsterile conditions led to a fungal meningitis outbreak that killed 55 people and sickened hundreds. In the wake of that disaster, many in Congress advocated for greater FDA authority and oversight. Gutierrez suggested something similar could happen with LDTs. "Are we going to wait until there is a disaster? Remember, CLIA came about in the first place because there was a disaster in the laboratories," he warned.