Building a Case, FDA AdComm Prep – Part 3 (final)

In Part 1, we covered the need for good communications planning, in Part 2, a little bit about how to go about it and in Part 3, some thoughts about the day of your meeting.

You have developed your narrative and from it derived the individual components of the presentation on need, safety, efficacy and any other considerations.  You have looked at the warts – and asked the hard questions about the data and issues that relate to the risk/balance ratio – like the number needed to treat and the possible safety issues, the potential for a REMS program, how special populations might be affected, how the trials were conducted and recruited, the makeup of the clinical trials, etc.

Now you have chosen your presentation team.  It may be a combination of internal and external team members.  External consultants can be very useful and credible, particularly if they have a background associated with the drug approval process or connection with a major medical society related to the treatment area.  You establish “leads” for responses in key areas, with back up experts to be called upon for highly specific information.

The presentation team needs training not only in presentation technique, but in question response.  Speakers particularly need to be taught flagging and headlining as it related to providing the answer in a meaningful way; and need to be practiced and rehearsed on a range of questions.  In fact, the presentation team should be prepared not only with mock panels made up of outside experts to simulate the day of experience, but drilled frequently on the range of potential questions they will face.  And conduct as many mock panels as are necessary.

In addition, a sponsor must identify those people who will be responsible for speaking with the media and they must be media trained – not the same as presentation training. Which brings us to an important point.

The AdComm meeting is not just a scientific meeting about the approval of a compound – it is also where the baton gets handed off from the regulatory side of an organization to the marketing side.  The AdComm meeting is where the branding of the product draws its first breath – it is the public unveiling of the drug – warts and all, and therefore it is important that there be a coordination of communication between regulatory and marketing at this time.

A good deal of sponsor thought goes into the Open Public Comment (OPC) period of a meeting when third parties and patients can state a point of view.  Should a sponsor encourage third parties to participate?  Support and connections of sponsors for third parties need to be disclosed at the time.  Such connections have an impact.  Purely organic commentary is perhaps the most desirable.  However, in any case, OPC should be considered carefully.  No panel is interested in being condescended to or patronized during this part of the meeting.  The most useful kind of OPC participation occurs when those offering commentary are shedding real light on an issue – particularly the human face to the condition.  If the condition is one commonly understood by everyone, that is probably not necessary.  If, on the other hand, it is a condition that needs a human face, it can be quite useful.  I have seen good examples of this and bad.  Each must be assessed on a case by case basis.

Finally, from a media point of view, it is a good idea to understand the media environment for your day.  Are there other FDA AdComms meeting that day – unusual, but not unheard of – that could overshadow or blunt your coverage?  Are there hearings on the Hill that could do the same?  Look at the social media commentary from the last meeting in this space and develop your own social media listening approach to the meeting.

In the end, it is about data, data and data.  But good skills, good planning and even good luck still are factors not to be ignored.

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