Device makers like to grouse about FDA, but they're not the only ones who feel they have an axe to grind. Recent warning letters suggest the agency is more frequently making use of detention to deal with violative products of all kinds from all kinds of places outside the U.S., but do the data support that idea? Let's peruse the FDA warning letter database to find out.
Can you say 'quadruple'?
According to the FDA warning letter search tool, the agency applied detention to 16 OUS companies in 2015 (the list includes only 15 when you use the search tool, but it appears to omit the Dec. 29 warning to Sorin, which as of this writing still appears on the recent warning letters webpage). That's up by quite a lot from each of the two previous years, when the agency hit only four firms with detention, and from 2012 when FDA slapped detention to five recipients of warning letters. Only two companies were hit with detention in 2011, but you get the point.
In contrast, a search with the term "quarantine" – the term used to describe the agency's sequestering of domestically manufactured products – yields exactly zero hits for 2015, a marked contrast to the seven warning letters in each of 2014 and 2013 that mention quarantine. I'll readily grant that the numbers I'm citing do not address other sources of data on similar actions, such as import refusal and so on, but these numbers address detention and quarantine on the basis of inspectional findings, and hence suggest the agency's policy has somehow changed.
Those who were following FDA's regulation of devices around the turn of the century will probably remember a set-to between regulatory attorney Larry Pilot and then-CDRH director David Feigel about the comparative rates of detention and quarantine. It'd be interesting to get the two of them in a room together now and hear what they have to say.
Whine with that cheese?
From time to time, I get calls and e-mails from device makers complaining about my use of words that appear in FDA's dictionary, but it's even more delicious when these companies hire public relations agencies to help out in that effort. It doesn't happen frequently, but this seems as good a time as any to address this peculiar phenomenon.
Whenever this happens, my first reaction is to advise the caller that the medical device business is an inherently controversial business. If you don't like controversy, may I suggest something a little more touchie-feelie, like the petting zoo business?
My second reaction is to advise the aggrieved party that I'm not responsible for FDA's regulatory terminology. If you have a problem with the agency's lexicon, do call them, but I have to say that kind of reaction comes across as that of a novice. I never get that from those who I know for a fact are experienced in the device business.
In any event, a device maker would be much better off dealing with whatever it is that got them in trouble with government in the first place. People in the PR business are happy to take your money to call me and e-mail me about FDA's use of the language, but you and I both have better things to do, don't we?