The Food & Drug Letter

Preparing for an advisory committee meeting is one of the biggest challenges most people will face in their careers. In these meetings, both product and reputation are on the line. When preparing for an advisory committee meeting, it is critical to start early, to home in on what matters most, and to make sure that the process is both effective and efficient. That can make a huge difference because the process can be stressful and difficult, and some of this stress and difficulty can be relieved and the level of preparedness raised by following the right path from the beginning. Comprehensive and organized planning and rehearsal will help prepare for a successful meeting. It is critical to create a succinct presentation and well-organized briefing book that speak to the audience. Focusing on key messages, organizing content, creating and refining the core presentation, writing the briefing book, prototyping the presentation and the briefing book so they are in sync, and preparing for the question-and-answer period in detail all are essential elements of preparation. This issue of The Food & Drug Letter focuses on planning for an advisory committee meeting.

Advisory committees are part of the FDA’s review system for the products it regulates.

The FDA will not let individuals participate on an advisory committee after Dec. 3, 2008, if they play a crucial role or have a financial interest greater than $50,000 in companies that may be affected by the committee’s actions.

When a manufacturer’s product will be reviewed by an advisory committee, planning is essential for a successful presentation.

It is essential for the team presenting to an advisory committee to plan effectively and to focus on what matters most.

It is helpful for the team to organize and assess each message relevant to likely issues and objections associated with it.

The prototyping process integrates what has already been done and helps sustain the conceptual approach.

When it is time to develop the presentation, the team first should develop a prototype, then determine where slides are needed and, finally, create the script and slides.

To prepare for the question-and-answer section, the team should gather all the questions from various sources — corporate communications, internal reviews and mock advisory sessions — and then distribute them among different teams, according to expertise.

Once all the content has been gathered and organized, it must be rehearsed and drilled, and mock advisory meetings must be held.

The preparation process is not just about preparing content — it is also about preparing people.