Advocacy - Lab Advocate
Lawmakers remain diligent in efforts to stop Food and Drug Administration (FDA) plans to expand its oversight of laboratory developed tests (LDTs). Republican opposition in the House has stalled draft legislation that would grant the FDA clear statutory authority over LDTs. Recent legislative efforts seek to delay and potentially stop the FDA guidance involving LDTs. The Association supports such efforts and has urged FDA to undertake a rulemaking process in lieu of a guidance. AACC rather recommends modernizing aspects of the Clinical Laboratory Improvement Amendments (CLIA) to address the concerns that have been raised about the regulation of LDTs.
In early April, Senator Pat Roberts (R-KS) successfully offered an amendment to S. 2700, the FDA and NIH Workforce Authorities Modernization Act, that would require the FDA to provide a formal explanation when the agency chooses to pursue guidance in lieu of the normal rulemaking process. The Senator expressed concern that the agency has issued more than 600 guidance documents since 2007. Although it is unclear whether this provision will take effect prior to the agency releasing the final LDT guidance, it does send a signal to the FDA of ongoing political opposition to its efforts.
Similarly in the House, there are ongoing efforts to derail the LDT guidance. House Republicans included report language in the fiscal year 2017 Agriculture Appropriations bill that would direct the FDA “to suspend further efforts to finalize the LDT guidance and continue working with Congress to pass legislation.” The Ranking Democrat on the subcommittee objected to the inclusion of this language.
AACC continues to be engaged in the discussion in Washington, featuring LDT regulations as one of two primary issues discussed by members of the Government Relations Committee during April 26 meetings with legislators.