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.
Sponsors spend many hours and dollars preparing for an Ad Comm. These well-choreographed efforts are keenly focused on FDA
and the committee; however, media and financial analysts should not be overlooked. They will be in the audience, making their
own judgments about the value of the product, the ability of the company to get it approved, and the drug's commercial potential.
And they will make those views public to a variety of stakeholders, including physicians, patients, advocacy groups, the financial
community, and employees. Therefore, it's essential that corporate communications and public relations teams participate throughout
the planning process to build, protect, and manage company and brand reputations.
Laura M. Liotta
Here are some tips and considerations for ensuring these important audiences hear your voice.
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.