Beware the Early Reviews
You only get one chance to make a first impression—and in the case of an Ad Comm, the media and financial community can make
your product's first impression for you. A few days prior to the meeting, FDA posts its own briefing, as well as company briefing
documents online, triggering the first round of media calls and coverage. These initial inquiries can set the tone for the
day of the Ad Comm meeting. Therefore, it is important to ensure that the contents of the company briefing document and the
communications strategy are aligned to convey consistent messaging.
The situation is complicated by the fact that many companies impose a "quiet period" during this time. On a case-by-case basis,
companies should decide whether to comment on briefing documents. Celgene, Gilead, Adolor, and DOR BioPharma, have issued
press releases announcing the availability of FDA and company briefing documents at
http://www.fda.gov/, so investors have fair and full access to data and product information. Others prefer to wait for the public forum to offer
Set the Stage
Whether working with an event management firm or handling the meeting logistics in-house, all participating parties must be
"in the loop" to ensure the show goes off without a hitch. Final rehearsals should be held off-site, in a confidential location
to ensure that the presentation information remains confidential from investors and competitors prior to the Ad Comm.
An on-site communications headquarters must be established prior to the meeting, and should be equipped with computers, Internet
access, printers, copiers, and a live satellite feed from the meeting room. This "communications war room" will provide a
secure area from which the communications and extended team can come to listen to the presentation and hold confidential discussions
on messaging, strategies, and outreach. Prior to the meeting, establish a process and chain of command for managing on-site/real-time
decision making for final communications following a committee vote.
Also consider setting up a separate room for media to conduct interviews, gain Internet access to write and file stories,
and take a break from the meeting. Your communications team should reach out to them during breaks to ensure they have access
to materials and post-meeting interviews.
The Curtain Rises
When the curtain rises on the big day, it's everyone's job to give their best performance. Remember, it is a performance—but
the stage extends beyond just the Ad Comm meeting.
Reporters—and competitors—will be watching and listening, so avoid discussing confidential information about the product or
company, or making any outcome predictions in the meeting room, hallways, or even when traveling to and from the Ad Comm.
Don't react in public to events from the meeting (including facial expressions). Instead, take reactions and private discussions
to the war room. All company personnel, whether they are presenters or spectators, should be cautioned to avoid unofficial
"hallway conversations" that can be easily overheard. Only company spokespersons should talk to the media.
Post-Show Wrap Up
Journalists are writing and filing stories as the meeting progresses, but the final vote of the Ad Comm is the big story of
the day. The better prepared you are, the faster the company can issue its final statement, and more effectively shape the
stories being written. Delay may result in official statements that are irrelevant or seem reactive or defensive.
Grab the appropriate draft from your scenario planning, revise the release to reflect the day's events, gain approval from
your review team, and issue it as quickly as possible. Depending on the materiality of the news, the release may need to cross
BusinessWire or PRNewswire before you can conduct any interviews. This process may not be cut and dried, especially when the
panel decision is mixed or unclear, and the race against the clock is on because FDA may issue a press release or host a press
conference of its own. Without the company perspective, that information will drive the way the story is told.
Once the release has been issued, follow up with media and update key stakeholders. Monitor for media coverage, distribute
coverage reports, and continue to build overall momentum for your product as it travels the last leg of the journey toward
a final FDA decision.
Take a Bow
An FDA Ad Comm is a major opportunity for companies to communicate key messages about investigational products; making effective,
consistent communications during and after the meeting is of critical importance. With ample preparation and consistent communications,
you will have done everything you possibly can to ensure that fans and critics alike leave with an accurate interpretation
of the clinical benefit of your star product—which will hopefully achieve blockbuster status and enjoy a long, successful
Laura M. Liotta is President of Sam Brown, a healthcare public relations agency. She can be reached at firstname.lastname@example.org