As noted in the Weekly Roundup on Friday, last week the FDA published a Final Guidance on the Open Public Comment period at FDA Advisory Committee meetings. On a side note, it is perhaps worth noting that this updated the Draft Guidance that came out in 2005. Yes, five years from Draft to Final. FDA social media guidance hounds, take note….
In any case, the Final Guidance addresses many of the perfunctory issues associated with the provision of commentary during an Advisory Committee meeting at the point of the regularly scheduled Open Public Comment (OPC) period. This, too, was summarized in Friday’s Weekly Roundup, or you can read the Guidance. Today, we’re not going to talk about how to participate in the OPC, but we are going to look at the why. Why should you, or perhaps more importantly, why should you not decide to participate. What are the factors at play? Here are a few things to consider.
Remember first of all that this part of the meeting is generally qualitative and not quantitative. It is not a contest to see how many speakers can speak for or against a particular proposition. Rather, it is generally speaking, to provide insight into a situation that is not clear from the data being presented by the clinical trials. And so the first question to ask oneself when preparing for an advisory committee meeting and faced with the question about sponsoring participation by others in the OPC period of the meeting is this – what is my goal here? Are you checking off a box on a list of things you think you should do, or are you actually trying to strategically communicate something that is important in supporting your application. If it is the former and not the latter, you may actually find that you are not really helping your cause.
I have attended many, many advisory committee meetings and watched literally hundreds of OPC speakers. Some have greatly benefited the issue being discussed. Some just pass time. And others have actually irritated panelists. The most effective use of a speaker or speakers is where the condition that is being treated by the candidate compound is perhaps not very well known and a patient can provide some insight into what it is like to have the condition. It can also be quite effective when the condition is one that might have a stigma involved with it – so that a patient can put a human face to the issue.
A good example of that was during the advisory committee meeting to consider the return of drugs to the market that treated irritable bowel syndrome (IBS). The subject matter of IBS might cause some to fail to take it seriously. But a patient who could stand up and provide a glimpse into what it is like not to be able to leave one’s home due to the condition was able to portray a very real, and very poignant picture of her suffering.
On the other hand, I have also seen speakers get up and explain what it is like to have a disease that the members of the panel are treating daily. That resulted in some expressions by committee members that they don’t need to be lectured about a disease they themselves know only too well. In other words, it was an example where patients were brought in to state the obvious.
There are no absolute rights or wrongs (except this – don’t be anything less than transparent about sponsorship of a speaker). The OPC can provide an important window into the non-data aspects that might be useful. But remember, the outcome of an advisory committee isn’t a popularity contest – the advisory committee and the FDA itself are driven by one thing – data. (There have been some rare exceptions.) If there is an issue in the data being presented, that issue is not going to be affected by a rowdy group of patients or investigators or third parties advocating for or against approval. So consider your approach to the OPC as you would any other strategic communications decision by first asking – why am I doing this and what do I hope to accomplish? That is my little guideline.