Can you imagine the stream of firms that venture in to their respective FDA district offices to give presentations on their Warning Letter response and offer their assurance that they truly “get it?”
You can be sure that theses firms had several dry runs and dress rehearsals in private session to hone the material. Their presentations were carefully crafted by the VP, SVP, EVP and vetted by the lawyers. Consultants who claimed to have been there and done that were invited guests at the prep meetings to give their insight into what “sells” at the FDA.
When the meetings at the FDA are over, the firm’s representatives heave a sigh of relief and offer each other assurances that it went well because it “felt good.” It felt good because no one on the FDA side of the table objected or got upset. So they go back to their colleagues and claim victory. The story gets exaggerated and turns into something like, “They really liked our presentation.”
In my experience, the only thing that sells at the agency is results. The FDA “response” is a practiced neutral expression that never is meant to signal agreement or acceptance. It’s all part of their “We’ll see it for ourselves when we come back to re-inspect” modus operandi.
However, we are starting to see a very interesting twist at the FDA that suggests they have finally figured out that there is more they can do to ensure effective action than sit through fancy presentations acting nonplussed while having smoke blown up their proverbial tailpipe.
The new twist is embedded in the Teva Warning Letter dated January 31, 2011, but only recently posted on the FDA website. (The delay of which I always find curious.)
The upshot of Teva’s Warning Letter is its problem of cross-contamination. Teva dutifully responded with its corrective action plan, which baited an entirely different response than usual from the FDA.
“We recognize that your October 7, 2010 response states that you are in the process of developing a risk management program for control of cross-contamination of the products produced at the Jerusalem Oral Solid Dosage plant. However, you did not submit that plan or data to support the effectiveness of the plan, with your response. We also recognize your commitment to finish the risk assessment within four months. Please provide us with any update on your timeline and the identification of resources allocated to address this issue.”
It is not uncommon for the FDA to expect a plan and timeline in a response. In fact, it is a frequent failing of companies to not provide a plan or timeline for completing corrective actions. However, in the case of Teva, the FDA also requested the allocated resources to be identified.
That is different and that is huge.
Frankly, this makes a lot of sense. The most successful corrective action plans have been those where the direct responsible individuals are named and appear on detailed project plans. There is a clear picture of what success looks like and how to get there. But most of all, the resources are identified to execute the work.
The regulation has always required sufficient numbers of qualified individuals to perform operations, so specifically asking about resource allocation to do the work is fair game. Unusual — but fair.
In the past, the sincere delivery of a good presentation might have has passed with the usual skepticism. Be prepared now to tell about the resources to pull it off.
Without the resources, it's just another pretty presentation.