Book Review: The FDA Advisory Committee Survival Manual

Review by Meredith Brown-Tuttle, RAC

The first thing that strikes you about this book is how beautiful it is: full of colorful illustrations and diagrams, with tabs for each subject, lots of white space to make it easy to read and, of course, my favorite, spiral binding so you can lay the book open flat and fully study the contents. In fact, the cover folds out to show you a timeline of what needs to happen in the 16 weeks preceding the Advisory Committee (ADCOM) meeting.

The content is broken down by topics, including:

• planning

• preparation

• practice

• wrap-up (working with the media, communication, and game-day logistics)

The entire process of preparing for ADCOM meetings – including strategy, developing the meeting briefing package, writing and organizing the slides, managing the slides process (creation, organization, production, and management during the meeting), rehearsing, and dealing with the media – is described in detail. Highlights include:

• How to assemble the best team to develop and prepare for the rehearsal and the real ADCOM meeting

• How to research and prepare intelligence on ADCOM members and why this is important

• How to get advocacy groups involved and how to choose the most appropriate groups

• Tips on what fonts and colors to use for the most effective slides, including examples of those that work and those that don’t

• Tools for positive media interaction

• How-to section and summary of each chapter

There are only a handful of consulting firms that support and help prepare companies for ADCOM meetings; 3D Communications has set itself apart by providing this practical manual giving an overview of the preparation process and helpful tips. The simple, concise writing and attractive layout combined with practical advice on ADCOM meetings show 3D Communications’ true mastery of knowledge that only comes from years of practice and experience. It reminds me of a classic little book used by all writers: The Elements of Style by William Strunk Jr. and E. B. White. This 105-page “bible” packed with concise, easy-to-read advice on how to write is very similar in tone and usefulness to the ADCOM guidebook. The only thing that would make this book better would be more in-depth examples, such as samples and templates provided electronically on a CD to accompany the book.

The take-home message from 3D Communications? Be clear, honest, organized, and brief in all communications. This book did exactly that. I recommend it to students and regulatory professionals who would like a general overview and understanding of the ADCOM process that hits all the highlights and supplies tips to get started.

Meredith Brown-Tuttle, RAC, is the chair of the RAPS Publication Task Force. She is a consultant for Regulatorium.com, an instructor for the UC-Santa Cruz Regulatory Certificate program, and author of “IND Submissions: A Primer” and “Regulatory Intelligence 101.” She can be reached at theregulatorium@gmail.com.