Disseminate peer-reviewed publications While care must be observed to avoid straying into the territory of nonapproved promotion, a benefit to you and to conference
attendees is the dissemination of peer-reviewed publications that address uses that are not approved indications. Without
going into great detail, there are a couple of significant changes in the FDA policy on dissemination of publications of clinical
trial results for nonapproved uses. The revised position, which was published in the February 20, 2008 Federal Register, would allow pharmaceutical manufacturers to distribute reprints of journal articles that support a particular use of a drug
or device that does not appear on its label. The key change in this policy is that FDA no longer requires the company to file
for the indication discussed in the publication (see figure 2), Chronology of Regulations Regarding Dissemination of Off-Label
Figure 2. Chronology of Regulations Regarding Dissemination of Off-Label Publications
As may be expected, concerns have been raised (on the part of Public Citizen; the US Congress including Henry Waxman; JAMA; The Lancet; NEJM; and others) that this will create an environment of unfettered off-label promotion by the industry. It is therefore strongly
advised that before adopting this strategy, you discuss it with the members of the legal, medical/regulatory affairs, and
compliance teams at your company.
Meet the experts Utilize members of the CE program by having faculty experts present at your exhibit stand. This serves as a way for CE participants
to obtain forms to acquire enduring materials from the CE event, and to engage the faculty in discussions of the topic. It
is not uncommon to provide a limited number of premium items, such as signed textbooks, to those who attend the sessions at
the booth. Medical societies that support these types of activities at their conventions report better booth attendance and
increased exhibitor satisfaction.
Be aware, however, that presentations at the sales exhibit cannot be accredited, and are considered promotional. Remember:
Presentations are considered promotional due to the environment where they are conducted. This places significant constraints
on faculty experts, which they may find hard to adhere to. They must keep comments and responses to questions within the labeling
of the product or products being discussed.
Consider A Therapeutic Tour/Poster Maze Another possible concept is a booth comprised of posters. They can be print posters with accompanying audio or "video posters"
that have the benefits of multimedia. Most "therapeutic tour" booths are freestanding. Some, however, are incorporated into
the main commercial exhibit. Either way, the content is focused, perceived as scientific, and covers data from the product
life, beginning with Phase II, and continuing through to the post-launch phase. This type of exhibit has been approved by
more than 25 medical societies, and is consistently among the most active booths on an exhibit floor.
Consider a Clinical Trial Booth The focus here is entirely on an ongoing clinical trial. Relatively new, it povides a place to meet with the current investigators,
as well as a way to reach new ones. It can also increase awareness of the trial and ascertain interest in potential trial
Again, caution, the exhibit cannot be used for promotion of the investigational compound. Protocol discussions should be limited
to the inclusion/exclusion criteria and the general terms of the patient population targeted. No efficacy/safety claims should
be made, and product mentions should be minimal. Medical/regulatory and medical science liaison staff most definitely should
man the booth.
These strategies can provide an enriched exhibit that fosters lively discussion.
Robert E. Batte is a founder and principle at Innovative Strategic Communications, LLC. He can be reached at firstname.lastname@example.org