On May 6, 2016, four Republican senators—Lamar Alexander
(TN), Richard Burr (NC), Johnny Isakson (GA), and Orrin Hatch
(UT)—sent a letter to FDA Commissioner Robert Califf
expressing concerns over the amount of time it takes FDA to revise,
finalize, or withdraw draft guidance documents. The letter follows
FDA's response to a 2014 letter by the same group of senators,
which sought clarification regarding FDA's use of draft
guidance to make substantive policy changes. Both letters argue
that leaving guidance documents in draft form for so long,
sometimes for years, makes it difficult to know whether FDA remains
committed to the policies outlined in old draft documents.
According to FDA's response to the 2014 letter, the Center for
Food Safety and Applied Nutrition ("CFSAN") had 16
pending draft guidance documents as of December 31, 2013, and it
took CFSAN between 90 and 1,502 days (a median of 454 days) to
finalize draft guidance documents.
The 2016 letter, while acknowledging FDA's response, requests
that FDA provides updates on: (i) the median number of days it
takes FDA to finalize draft guidance; (ii) the list of guidance
documents still pending finalization; (iii) the plan for FDA
Centers and Offices to systematically review outstanding and future
draft guidance documents in a timely manner; (iv) the method used
to train FDA staff and employees about how to use draft guidance
documents, including information about who conducts these
trainings, how frequently they occur, and the content and forum of
the trainings; and (v) whether a draft guidance document that has
not been finalized should be construed as reflecting FDA's
current thinking.
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