No doubt some are tired of hearing me go on about the FDA budget, but industry thinks the agency is under-funded, too. Most who are part of this discussion believe FDA would be more functional with appropriate appropriations, but they ignore the dynamic necessary to fully fund FDA. Hence, the dysfunction persists.
To wit: Dealing with FDA’s public affairs staff is typically not a bad experience unless they have to consult with others at the agency on fairly detailed matters. For instance, I’d written last year about a Federal Register notice addressing pre-emption of state law with regard to the physician labeling rule for drugs. The notice mentioned devices at several points as well as Riegel v. Medtronic, and I thought to myself, “in the absence of a physician labeling rule for devices, could this declaration affect liability for devices?” After all, FDA went way out of its way to discuss devices in the notice.
Several weeks and a number of e-mails later, all I had to show for my troubles was a promise from some unnamed individual that this did not affect device pre-emption via physician labels. It was clear that someone at FDA expected to handle the query by regurgitating the contents of the FR notice, and the agency’s public affairs staff got stuck with the dirty work of middleman. It was a lot of effort for nothing.
Warning letter faux pas
Recently, I called a diagnostics manufacturer about a December 2011 warning letter FDA had posted April 17, and the company told me that was the second appearance of the letter on the recent warning letters page, appearing there for the first time in January. When I contacted FDA, the first explanation was: “Apparently, it's part of our web process. Letters are posted according to date on the letter as well as the posting date.” The e-mail also said there was “no compliance or other reason” for the reposted warning.
My response was: “The company states it had been posted at the beginning of the year and was reposted on the 17th.”
FDA’s response: “Yes. I think that's correct. It's part of the web process – not sure what the reason is but there is nothing more to it.”
Now I’ll acknowledge that I didn’t say “posted at the recent warning letters page at the beginning of the year,” but I’m pretty sure that’s how it was interpreted. After all, when does a warning letter show up in the archive without hitting the recent warning letters page first? Never. That’s how often. Trust me, I’ve been writing about warning letters for all but three years since 1999. I know the drill.
I questioned it further. The explanation I got was as follows:
The Warning Letter was posted on April 17 (Recently Posted List), and due to the letter being issued in 2011, it shows in two locations.
1. The Recently Posted List
2. 2011 listing of warning letters
On the next posting date (April 24) the warning letter will only show in the 2011 listing of warning letters.
The reason I find the agency’s responses unconvincing is that FDA’s practice has never been to post warning letters to the recent warning letters page more than once under any circumstances, and I’m pretty sure those letters never appear in the archive and the recent letters page simultaneously. If I’m wrong, FDA needs to say so.
A knowing deviation from standard practice or a boo-boo?
The company told me the first explanation they got from FDA staff was that the letter had been accidentally deleted from the archive and consequently had to be reposted to the recent warning letters page. That sounds a lot more plausible than any explanation I received from FDA. The CEO of this company also said they received a lot of calls from customers in January about the warning letter, and I find it hard to believe they got a lot of customer calls about the warning letter at that point in time if it had been posted only in the archive. That idea just does not pass the sniff test.
The best explanation I can come up with is that an overworked FDA employee screwed up and was playing CYA. This episode demonstrates why FDA needs a bigger budget, and I’ll say it again: Bully to the Alliance for a Stronger FDA, but Congress will do next to nothing – or worse – about significant increases in appropriations until they hear from voters. Any other understanding of that dynamic is dead wrong, and any efforts to meaningfully boost FDA’s appropriations that do not incorporate that understanding are doomed. Period.