Advocacy - Lab Advocate
AACC recently endorsed legislative efforts to delay Food and Drug Administration (FDA) work on finalizing its guidance regulating laboratory developed tests (LDTs). Report language included in H.R.3049, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill for fiscal year 2017, directs the FDA “to suspend further efforts to finalize the LDT guidance and continue working with Congress to pass legislation.” The Association urged the Senate panel with authority over FDA funding to include similar language in its version of the bill. The subcommittee did not address the issue during markup, but it could re-emerge as an amendment when the full Senate votes on the bill or at a later date when a House-Senate conference meets to work out differences between the two measures.
On a related item, leading Republican lawmakers, such as Senators Lamar Alexander (R-TN) and Orrin Hatch (R-UT), are raising concerns about the FDA’s continuing use of guidance documents to set agency policy. Particularly, lawmakers are concerned about:
- The use of guidance to make substantive policy decisions;
- The length of time it takes the agency to withdraw, revise or finalize the document; and
- Agency staff possibly enforcing draft policy before it is finalized.
Building off these concerns, Senator Pat Roberts (R-KS) recently amended S.2700, the FDA and NIH Workforce Authorities Modernization Act—which authorizes the two agencies to spend additional funds to attract and retain top scientists—to include a provision requiring the FDA to provide public justification for choosing guidance over rulemaking. AACC has endorsed the Roberts provision. The bill will be considered by the Senate as part of an overall ‘Innovation’ package to streamline the FDA review process.