Advocacy - Lab Advocate
After failing to meet the expected June release date for its final guidance on laboratory-developed tests (LDTs), FDA now projects that the document will be released by the end of the year. This might be the agency’s last chance to release the document, as it is expected that the incoming administration will review the proposal, along with many other initiatives, in the context of its own priorities.
Members of Congress remain concerned about the FDA LDT guidance. Earlier this year, the Senate Health Education, Labor and Pensions Committee amended S.2700, the FDA and NIH Workforce Authorities Modernization Act, to require the FDA to explain its rationale for choosing guidance over the public rulemaking process. Similarly, the House Appropriations Committee expressed its displeasure with the FDA guidance by including report language in the 2017 FDA funding measures directing the agency to suspend work on the final LDT guidance pending congressional action. AACC backed both proposals.
There has been some speculation that Congress may take up the LDT issue this fall during discussions involving FDA reform. However, with the limited number of legislative days remaining before the election, it is unclear whether this issue will be a priority.
AACC continues to advocate for CLIA reform rather than expanded FDA oversight of LDTs. Under the association’s proposal, the Centers for Medicare and Medicaid Services would redefine LDTs to focus attention on new or significantly modified tests and require laboratories to demonstrate LDTs are clinically valid for the medical purpose for which they are intended.