Imagine the stream of firms that venture in to their respective FDA District offices to give presentations on their Warning Letter response and to offer their assurance that they truly “get it”.  You can be sure that theses firms had several “dress rehearsals” to hone their material before stepping into what they perceive to be hostile territory. 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 to 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 high-fives 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, decidedly-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 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 quite curious.)

The overall theme of Teva’s Warning Letter is a problem of cross-contamination. Teva dutifully responded with their corrective action plan, which baited the usual response from the FDA–with a bit of a twist.

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 (OSD) 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, FDA also requested the allocated resources to be identified.

That’s the twist, and that’s 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 in 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 passed with the usual skepticism. Now be prepared to tell about the resources to pull it off.

republished and adapted from the QA Pharm