Practical Need-to-Know Tips About Changes to AdComm Preparations

The FDA has been settling into their new digs in Montgomery Maryland called White Oak, and the move of such a large agency into a new facility has been a process, not an event, as one might imagine.

The old FDA facilities lacked any kind of venue for the agency to hold large meetings.  As a consequence, meetings such as Part 15 meetings and advisory committee meetings were held at other facilities.  With respect to the latter, advisory committee meetings were generally held in various hotels around Maryland in large ballrooms where the day before, there could have been a wedding or Bar Mitzvah.   For those of us who attend a lot of AdComm meetings, we got to know the benefits and drawbacks of some of these venues. My favorite, for example, was the Hilton in Gaithersburg because for lunch, I could race to the Chipotle, and the gift shop for snacks was not bad.

The hotel venues also presented sponsors with a number of options to meet their needs throughout the ordeal of an AdComm meeting, and sponsoring company personnel often stayed at the same hotel where the meeting was being held.  Private rooms could be secured for media interviews and in which media could work, and rooms could be reserved for the sponsor staff to work privately.

But now, you may have noticed if you watch AdComms, many meetings are no longer being staged at hotels, but rather at the FDA’s new White Oak facility.  That may not sound like a big change – a room is a room is a room, right?  But in fact, logistically, it does offer several changes that you need to consider whether your are a sponsor, a consultant working with a sponsor, an interested observer or even media.  Here are some tips for navigating the new venue:

• Get there early! AdComms start early and while you use to be able to just drive up to one of the hotels, park and hop in, there is a different scenario awaiting you at the new FDA Campus.  You will likely be directed to a surface area to park and then you will have to enter the facility at Building 1, where you will have to walk through a screener, though you don’t have to show ID and be processed.  However, once through, you then have to get to Building 31 which is where the meeting room is located.
• Food – Hunting and Gathering. At the hotels, you could eat there or have time to run out and grab something.  You won’t have time to run out and grab anything here.  That means the options are fairly limited.  The agency does contract with a vendor who opens a snack bar, can serve lunch and provides some kiosks to also sell snacks, but there is no StarBucks on site!  I heard from buddy Brian Reid (@brianreid) that there were long lines and choices were fairly limited. That means for those of us who attend as individuals, well you may want to consider bringing your own lunch.   For sponsors, catering can be arranged with this same vendor for your staff, or you do have the option to arrange for outside catering, but the logistics there may be tricky because they will have to arrive through Building 1, go through screening and get to Building 31.  Your staff will have to facilitate that.
• Roomies. At the hotels, sponsors generally hired out a room for media to work and to conduct interviews and a “war room” where the sponsor, staff and consultants can work privately and presenters can take a break or confer.  At the new facility, there are two rooms that a sponsor can utilize in addition to the fact that there is a media room.  However, sometimes an AdComm considers issues related to more than one sponsor in a day – usually one in the morning and one in the afternoon.  That may mean that a sharing arrangement needs to be worked out or coordinated and the timing figured out.  Multiple sponsors may present some challenges so this needs to be closely coordinated with FDA through working with the Executive Secretary of the advisory committee in question, otherwise also known as the Designated Federal Officer (DFO).
• Getting in the Equipment – A sponsor may have some ancillary items to bring along to a meeting.  The audio-visual equipment needs should be coordinated ahead of time with the DFO.
• Where to Stay, How to Get There.  The FDA has put together a summary sheet of some of the logistical issues, including a few nearby hotels and public transportation tips.  It is a work in progress, however, and the agency is working on making it more comprehensive.
• Computer Access and Video Viewing.  There is WIFI access in the room, but it is password protected and the password is administered by the press officer for the meeting.  The sponsor can ask for access.  However, it sounds like members of the public may have to fend for themselves and will need their own means of mobile access.  There is also a connection that is being attempted to log onto a part of the Web site to watch the meeting, but this too is a work in progress at this time.

The room is comparable in size to the ballrooms of the hotel era, though perhaps wider. Members of the public must stay at the meeting room complex and cannot wander off to other areas of the agency.  The priority for use of this room is for advisory committee meetings of the 16 committees, but where there is a calendar conflict, one could still be assigned a meeting at one of the hotels in the area.

So while not radical changes, there are certainly differences and in the coming months, certainly the majority of AdComm meetings will be held at the new facility.  It makes sense to have the meetings at FDA, but I know I am going to miss the tacos.