Does the FDA Have More to Talk About?

There are a number of angles that one can look at the FDA to see if there are indeed winds of change blowing through the agency.  Recently, we looked at the level of warning and untitled letters coming out of DDMAC as one indicator that there might be increased regulatory scrutiny now that the Bush Administration's "off-switch" for domestic agencies seems to have been turned back on.  Also recently noted was the rash of seizures that seemed to be happening at a quicker pace. 

Another indicator might be looking at press releases issued by the agency.  So I took a look at the press releases issued by the FDA for the first six months of 2009 and compared them to the same period for 2008.  I also picked out and counted those that related to directly to regulatory action, as opposed to those announcing approval actions or were relatively benign announcements or even in some cases, amusing headlines.  (See, "FDA Takes Next Step to Establishing Overseas Presence" for example).  

It turns out that the FDA has more to talk about this year than last.  About 50% more.  During the first six months of 2008, the agency issued 80 press releases as compared to the first six months of 2009 when it issued 120 press releases.  And apparently, there is more to say because the agency is doing more.  

In looking at 2008, there were 9 regulatory or legal actions taken against companies.  These involve injunctive relief or closure of facilities.  However, in 2009, there were 12 regulatory actions taken; 9 arrests or criminal actions and 3 product seizures.  Combined, that reflects over a 100% increase in legal and regulatory actions announced by the companies.  

Does that necessarily conclude that the agency is picking up the pace of enforcement?  It is an indicator, but like all indicators, it is not absolute.  Some of the criminal sentences and decisions handed down in 2009 were likely begun in 2008, but only saw their conclusion during 2009.  Also, perhaps manufacturers are just being extra naughty this year.   But if you remove the criminal penalty and legal actions and just count pure regulatory announcements, there is still an impressive increase this year over last.  

What does it mean?  It would be easy to predict that this pace will continue to increase and that there is going to be a greater vigilance upon manufacturers in the coming months and that will probably be true on all fronts - from good manufacturing practices to labeling issues and communications regulations.  It is time now, more than ever, to make sure one is toeing the line.  

Comments

[Steven Grossman]

Mark---I agree that enforcement actions are likely to increase across the board and that caution is advisable. However, I am not sure this can be inferred from press releases or enforcement actions in the first half of 2009. As you note, much of the staff work started in 2008 or earlier. Other items have waited for someone (anyone) to be in charge. Altogether, there is a backlog of policy and enforcement decisions. I have explored the consequences of this at: http://www.fdamatters.com/?p=269. This is likely to skew comparisons for at least the first six months of Dr. Hamburg's tenure. Perhaps, this is reason for even more caution by industry...until the nature and direction of FDA leadership becomes clearer. Thanks, Steven