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Senate Committee Questions FDA's Use of Draft Guidances

In a letter to the Food and Drug Administration, a group of U.S. senators from the Committee on Health, Education, Labor & Pensions expressed "significant" concern about the agency's apparent reliance on a process of issuing draft guidances to make substantive policy changes. The four Republican senators, led by ranking member Lamar Alexander (R-Tenn.), noted, among other things, that these draft guidances are increasingly becoming default FDA policy in the absence of final guidance.

The May 6, 2014, letter criticized the FDA for the way it handles the guidance process. First, the letter noted that the FDA's website does not distinguish between draft and final guidances, seemingly giving equal weight to both and "undercutting the importance" of the public comment process. Second, the senators highlighted the fact that the agency does not revise, finalize, or withdraw the draft guidances in a timely manner to reflect updated information discovered as a result of public comment.

Third, despite that draft guidances, labeled "for comment purposes only," are intended to express the agency's initial thinking on a topic and are not binding on the FDA or the public, they often are the only information that the medical community, FDA-regulated entities, and FDA review staff may have on the agency's current position on important issues. Stakeholders feel constrained by the policy positions laid out in draft guidance, even (or perhaps especially) when those positions are inconsistent with consensus within the biomedical community-a fourth concern of the senators. In its September 2012 Report to the President On Propelling Innovation In Drug Discovery, Development, and Evaluation, the President's Council of Advisors on Science and Technology (PCAST) recommended, among other things, that the FDA rely on-and reflect the consensus of-the scientific community in developing and revising guidances. Despite this recommendation, however, the senators cited recent draft guidances by the FDA that did not incorporate recommendations by the international scientific community.

In the closing of their letter, the Committee asked the FDA to provide specific information, including a list of all Level 1 draft guidances, the status of those guidances, and a timeline for finalizing or withdrawing the guidances. They have also requested an update on agency-wide activities to implement "best practices" for the finalization of guidances, in accordance with a 2011 FDA Report on Good Guidance Practices-Improving Efficiency and Transparency. Additionally, the senators asked whether the FDA in fact had implemented the recommendation to rely more on the biomedical community in developing and revising guidances, and if so, asked the FDA to describe those efforts. The letter also asks for information concerning the agency's policies to prevent its own staff from defaulting to the draft guidances in the absence of final guidance as well as historical averages for finalizing guidances over the past five years.

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