It's not what you say—it's how you say it As with any presentation, spokespeople must be credible and true to the science. But an FDA Advisory Committee presentation is like a regular scientific presentation on steroids—presenters must compel and convince the committee with their delivery.

"Scientists underestimate the importance of a strong delivery," said Bierer. "You need to show the advisory committee that you are confident in your data and passionate about your positions. If they see you truly believe what you say, it will help convince them too." It is here that Bierer believes communications experts can make the biggest impact: They know how to organize and deliver content most effectively.

Know who is in the audience Just as two divisions of FDA are involved in switch decisions, Rx-to-OTC advisory committees are actually two committees put together: the Non-Prescription Drugs Advisory Committee and the committee representing the indication, which in Prilosec's case was the Gastrointestinal Drugs Advisory Committee. Consequently, sponsors must win over two separate committees, each with its own agenda.

"It is helpful to analyze each of the committee members to find out his or her specific interests, concerns, and biases," said Dent. "This allows you to target your presentation to those specific issues, as well as to anticipate negative questions."

Build a cohesive, convincing case FDA typically grants sponsors an average of 75 minutes to present all of their data, and another half hour or so to answer questions from committee members. Companies can submit a briefing document beforehand, but members usually don't have a lot of time to read and process that information. Therefore, sponsors must develop a clear, convincing, and laser-focused case for approval.

"No matter how great your data, dumping years of it on the committee without context won't convince them," said Gardner. "Guide the panel through it in a logical and persuasive way."

The case for an OTC switch and the data that support it should be largely shaped around the questions FDA provides to the advisory panel at the start of the hearing—similar to a judge "charging" a jury. FDA sends those questions to sponsors anywhere from a month to the night before the hearing—so companies should be prepared to scramble and change their presentation to accommodate the questions, if necessary.

Companies should assign a team to compile Q&As and "drill" presenters before the hearing. In particular, when it comes to the negative questions, companies should ensure that presenters have appropriate data-driven answers. "You can win or lose on Q&A," said Gardner. "I've seen companies go down in flames because their answers were confusing. You've got one shot to answer the question and get your point across."

Practice makes perfect In the end, engaging in a successful advisory committee meeting comes down to practice—as individual presenters and as a team.

The Rx-to-OTC team should hold a few "mock" advisory committee hearings. The panels should be composed of thought leaders in both the specialty area and OTC medicines in general, to reflect as closely as possible the make-up of the advisory committee members. The mock panels should be staged realistically, with the room arranged like a typical advisory committee hearing to help presenters visualize the big day.

In addition, presenters should practice in front of the organization's senior management, who can sometimes see critical points that were omitted by the team. All this input should then be used to better prepare the team to face FDA.