Two-For-One FDA Guidance Docs

Back in February I noted the steep drop in public inspection documents posted by the FDA immediately after President Trump took office (see “One Immediate Impact of President Trump On The FDA”).  For that essay I created a graph that clearly showed the steep drop.  But that was only one month after the new President took office.  What has happened since then?  This week I updated my graph so we can see how things are progressing. 

One theory was that the drop was something temporary that typically happens whenever a different party takes over the Presidency and we would soon see a return to normal.  Like most new administrations, this one issued a freeze on new regulations for a period of 60-days.  But that period ended a few months ago.  What affect did it have, and what affect did its removal have?

Full graph of FDA Public Inspection Documents through June 17, 2017
Click on graph to enlarge

Here is the newly updated graph that contains data right through last Friday.  There were a handful of weeks where the number of public inspection documents were in the “normal” range.  The trend seems to be going up, but the numbers for the FDA have still not returned to pre-inauguration levels.  I don’t know why that is, but my theory—and the theory of a few others in the industry—is that the problem is with the “Two-for-One” Presidential Executive Order.  It could be causing FDA to hold back on the publication of some documents, including some guidance documents.  To be fair, I have spoken with others in the industry that disagree that the “Two-for-One” order is the likely cause.


The so called, “Two-For-One” Presidential Executive Order requires government agencies to eliminate two “regulations” for every new one.  The Order’s definition of regulation appears to include guidance documents published by agencies to help companies comply with existing law. 

The problem is, even the most obsolete guidance document can still contain a small amount of information that is still valid.  Even if only a paragraph is still valid, if that information is important and is not published anywhere else when the original guidance is eliminated, the agency might need to extract that paragraph and insert it into a new guidance document.  If a larger portion is still valid, just revising that document to eliminate the obsolete parts might require the elimination of two other full guidance documents.  As you can see, this could quickly devolve into a full stoppage of all new guidance, let alone new rules.  That would lead to even more obsolescence in existing guidance.

I understand that this is the goal of the proponents of limited government.  It is not my intention to critique that goal.  My intention is to criticize the “Two-for-One” approach to achieving it.  “Two-for-One” turns a government that arguably wasn’t operating as well as anyone would like, into an even more worthless drain on business and personal life.  You may have thought that’s what it was before “Two-for-One”, but I argue that it is much worse now.  The cost of government is still just as high, but the value we can extract is lower. 

“Two-for-One” may seem like a good weapon against the high cost of regulations but I believe that weapon is too blunt.  What we need is a more intelligent way of eliminating obsolete or unneeded regulations.  For that to work, it ought to result in more guidance documents, webinars and meetings (the things that are reflected in the FDA public inspection documents I track), not less.

I’ll admit, “Two-for-One” is an interesting experiment, and it is at least remotely possible it could turn out to work as intended once the government can adjust to it.  I just hope we don’t lose too many of the most dedicated government workers out of frustration while we wait to see if it does.  We’re not likely to get them back.