Late last year, an amendment to the Federal Food, Drug, and Cosmetic Act placed FDA Advisory Committee meetings, or "Ad Comms," in the script for nearly all pharma and biotech companies with late-stage products. Before FDA will consider granting final marketing approval, products that include an active ingredient not previously cleared by the agency face the inevitable spotlight of an Ad Comm.

This performance may seem like a formality compared to the lengthy and complicated paths some products travel to get to this point. Ad Comm meetings are important, however, as FDA often considers the committee's guidance when reviewing a drug application. Prior meetings and conversations with FDA usually take place behind closed doors. But with Ad Comm, the doors are opened, and proceedings play out among the agency, the sponsor, and a panel with varied expertise, personalities, and perspectives. The product's merits are debated, leading up to a final act—when the committee votes.

Laura M. Liotta

Study Your Lines and Rehearse

When striving for a perfect performance at Ad Comm, no company should "wing" the communications component. Prepare extensively, beginning with a communications strategy that includes credible, consistent, effective messages and positions on critical issues. These messages should be clear, balanced, compelling, and informative—not to mention controlled and rehearsed. The day of the Ad Comm is no time for surprises.

Speakers should train in the same way Presidential candidates do when preparing for a debate: Mock panels should be conducted early and often, with a final dress rehearsal held in front of a relevant external audience of experts. These rehearsals are critical not only for increasing the confidence and comfort level of the presenters, but also to gain additional insights about and prepare for tough questions.

The public relations team should prepare for three potential outcome scenarios (favorable, neutral, and negative), so the team can move quickly to issue a prepared statement following the committee's final vote. All company and external spokespeople should be trained for each potential outcome and prepared to answer questions from the media and analysts—a key step to ensuring accuracy and maintaining the brand and corporate image.

Know Your Audience

Companies spend significant time and effort trying to understand committee members—their background and medical expertise, training, positions on issues at previous meetings, etc. Yet it is essential to know the other audiences in the room, including journalists, financial analysts, and competitors.

To ensure accurate coverage, conduct media and analyst briefings in advance, providing background information so writers can move quickly to file stories following a decision. Reporters from newswires such as AP, Dow Jones, Reuters, and Bloomberg report on hundreds of new products each year and appreciate the opportunity to gain greater context on clinical data and other relevant disease background information prior to the meeting. Of course, the briefing information must be public and non-material to the sponsor.