Responses to the Food and Drug Administration’s (FDA) Warning Letters and the FD483—a written notice of deficiencies found during inspections—are usually full of commitments. They involve what will be done to correct compliance problems, and when it will be done. The FDA has even started to ask how they will be done—i.e., do you have the resources to do the work?
If these questions are not fully addressed in the FD483, then the FDA will ask them again in the subsequent Warning Letter, in the part where they acknowledge receipt of the firm’s FD483 response—and the inadequacy of it.
It is very formulaic and predictable.
So my first point is that there is no excuse for an inadequate response to an FD483 or a Warning Letter. There are plenty of Warning Letters on the FDA website that provide examples of poor responses and what the FDA thinks about them. There’s no excuse for not knowing how to respond.
Reasons for poor responses include:
• Arrogance (What problem? Let me explain why we have no problem.)
• Bad advice from house counsel (Dance around the edges, but never admit having a problem.)
• Minimalism (Commit as little as possible and don’t look for other problems.)
• Being far removed from the problem (Responses are so bad that it makes your technical insiders embarrassed.)
• No root cause (Do a lot of stuff, but little is directed toward the real problem.)
• Poor writing skills (It’s difficult to follow the storyline because you have no idea what you want to say.)
My second point is never, ever miss a commitment date. If anyone were to ask the leadership of any company under FDA enforcement action whether FDA commitments should be taken seriously, the response would be a resounding, “Of course.”
Yet actions say differently.
It continues to amaze me how many companies miss commitment dates. And even more amazing, the senior management had no clue it had missed them. This is totally unconscionable and an indicator of why the company has compliance trouble in the first place.
Reasons for missing commitment dates include:
• No system to track responses and commitments
• Responses and commitments are buried with hundreds of other TrackWise records, most of which are also overdue
• Overly managed projects until there is more planning than action
• Lack of visibility is a standing agenda item in the management boardroom
• No accountability—at any level—for results
• Agency responses are kept secret or not sufficiently distributed to employees
• Those responsible for doing the work had no idea that a commitment was made
The best way to think about the seriousness of a commitment to the FDA is to remember that the agency already suspects a noncompliant firm to be untrustworthy—or at best the FDA is neutral about the company’s credibility. To not deliver on a commitment date just confirms the FDA’s suspicion and puts the relationship on shaky ground.
Not providing an adequate response simply indicates being out of the mainstream of pharmaceutical industry know-how. And missing commitment dates is nothing less than breaking a promise.
How would you feel if you were not taken seriously?