Earlier this month, the FDA announced that it was withdrawing 47 draft guidance documents that never made it past the draft stage. Since guidance documents are said to be what the FDA’s current thinking about a topic is, draft guidance documents might be what the FDA is thinking about thinking, subject to public comment and further internal review. An open question is whether drafts create an expectation that you should think (and act accordingly) based on what the FDA has said it might think if and when the draft is made final. Final guidance documents are supposed to interpret regulations rather than create new requirements, although this restriction is often debatable.
The withdrawn drafts were issued between 1991 and 2012 and cover a variety of mostly highly specific topics. One that was more general is Accelerated Approval Products—Submission, which was from 1999. The most prolific year for withdrawals was 2010 with 12, many of which were for Class II special controls for specific devices. Fourteen were from the 1990s.
The announcement was nicely forthcoming as to why these drafts had languished. It explained that many of these were not finalized “because of higher priorities and resource issues” and that some had become outdated since their creation. Changing priorities and lack of resources are understandable, but presumably these become bigger problems as the time from creation to finalization or withdrawal increased. One can also imagine that the principal persons behind some of these documents have long since left the agency and that continuity of effort with personnel transitions may be a problem.
The FDA did not share how many other drafts from the same period live on, perhaps in a somewhat moribund state. One such older draft addresses Implementation of the Biomaterials Access Assurance Act of 1998 which has a release date in 2001, although a listing of drafts says it is from1999. This document provides a procedure for petitioning the FDA to assert that a biomaterials manufacturer—as opposed to a device manufacturer—should have been registered with the FDA.
While getting rid of stuff that perhaps no one was working on, and no one was waiting for, is a good housekeeping effort, the pace of draft creation may still be outstripping the ability of the FDA to deal with them in an expeditious manner. One current list of draft medical device guidance documents has 25 items from March 2014 to May 2015. A different list from the agency has 55 draft guidance documents from March 2002 to May 2015.
One measure of productivity may be the time from draft to completion for those guidance documents that are finalized. For example, there have been five CDRH guidance documents issued in 2015 through April. These had draft issuance dates of 2011, 2012, and 2014 (3). The three from 2014 probably reflect the fastest these things can move. The one from 2011 perhaps not so much, especially if you fall into a group for which that awaited guidance was important.
A related effort in the FDA’s FY 2015 plan is to conduct focused reviews of final guidance documents from the years 1985, 1995, and 2005. This is said to be the first part of a rolling review of guidance documents more than 10 years old.
Many of us may be guilty of taking on more than we can get done, or losing interest in something we started or thought about starting. New demands on our time also may be a factor in other work languishing. My university office had multiple horizontal surfaces with piles of things I meant to work on. During rare cleanups, I jokingly told people that I was throwing away any action item that was more than 10 years old, but I didn’t do it consistently. The FDA may be following a similar plan.
My study at home had a complex sailboat model that I had barely started and rarely worked on, until it came time to move and I somewhat reluctantly threw it away. My loving wife allowed that perhaps the pleasure I derived from studying the plans and looking at the parts had made it worthwhile even though I never finished it. The FDA may follow this plan as well.
William Hyman, ScD, is professor emeritus of biomedical engineering at Texas A&M University. He now lives in New York where he is adjunct professor of biomedical engineering at The Cooper Union.