Exhibit compliance in healthcare is often viewed as complex and restrictive, but that perception is more myth than reality. While it’s true that healthcare marketers face a unique set of regulations when planning exhibits, navigating them isn’t as difficult as some believe. The real challenge lies not in the rules themselves, but in understanding how they’re interpreted and applied.
There is a misconception that compliance is one series of road blocks after another, but this picture often comes from outside the industry: media narratives, generalist marketers, or agencies unfamiliar with the nuances of healthcare environments.
The reality of the situation is simple and relatively easy to explain. First, let’s dispel the myth that there are unmanageable numbers of “rules” to be followed.
Exhibit Compliance and Face-to-Face Marketing
What’s frequently overlooked is that major pharmaceutical and medical device companies have dedicated legal and regulatory officers. The role of these officers is to interpret guidelines and laws long before promotional activities — including exhibits — go live. That means exhibit agencies and vendors are already building solutions within a clearly defined compliance framework.
However, these internal review processes can slow down approvals and disrupt timelines. The real challenge is not a wall of regulations, but a need for collaboration and foresight.
What do regulatory and compliance officers need to consider before giving the green light to promotional initiatives? Here is their framework:
The FDA
The FDA has said much less about exhibit compliance issues than many in the industry believe. A simple example: the FDA, in the 1980s, said there should be a separation between promotional and medical activities. That’s all. There was no suggestion that a wall of mums should separate two sections of the exhibit.
The FDA regulates the safety and effectiveness of drugs, and FDA judges whether a product’s benefits to users will outweigh its risks. The FDA’s Office of Prescription Drug Promotion (OPDP) is responsible for regulating the advertising and promotion of drugs, as well as enforcing actions and compliance.
Through the Office of Prescription Drug Promotion (OPDP), the FDA regulates anything disseminated by or on behalf of a company that can be considered promotional, including:
- Spoken Word
- Advertisements
- Graphics
- Promotional Materials
- Social media and websites
Anything that states or implicitly suggests an unapproved claim for a product is subject to a Notice of Violation (NOV).
The FDA, more than anything else, is concerned about the quality and accuracy of promotional communication. This includes ensuring that marketers only make product claims as stated on the approved product label and that marketers present adequate fair balance, as in the presentation of risk information.
Sunshine Act / Open Payments
The most recent addition to the canon of what is allowable at conventions is the Sunshine Act/Open Payments, federal legislation that comes with penalties for non-compliance.
This legislation mandates transparency, not prohibition. It doesn’t ban payments, gifts, or transfers, but rather mandates reporting of individual payments, gifts, or transfers/gifts that are individually over $100 or that cumulatively total $100 or more for the year.
If you follow proper tracking and reporting processes, and there’s a chance you may provide something to the same physician at multiple conventions or in different contexts, you are not required to report each instance individually. That said, proactive reporting is recommended. It helps ensure you’re aware of when (or whether) the total value provided exceeds the $100 threshold, either in a single instance or cumulatively within a calendar year.
Under the Sunshine Act, companies are permitted to offer healthcare professionals (HCPs) educational gifts, as long as those items do not have “substantial value,” which is again defined as $100 or more. Educational items may include:
- Textbooks
- Medical journals
- Anatomical models
These items may be provided in digital formats (e.g., PDFs or eBooks), but exhibitors cannot provide the HCPs with a physical device, such as a tablet, to read the material on, as this would be considered an item of substantial value. The content is permissible, but the hardware is not.
PhRMA Code & AdvaMed Code
Before the Sunshine Act, the PhRMA Code, enacted by the Pharmaceutical Research and Manufacturers of America (PhRMA), served as a form of industry self-regulation, intended in part to preempt government intervention. Around the same time, the Advanced Medical Technology Association (AdvaMed) issued a similar code for medical device and equipment manufacturers.
These voluntary codes share a common principle: gifts are not permitted unless they are clearly intended to benefit the patient.
Shortly after the PhRMA Code was adopted, the Office of the Inspector General (OIG) issued a draft guidance that the PhRMA Code established a “good starting point” for questions about gifts and their value. The PhRMA code covers a detailed framework for reviewing issues related to the Anti-Kickback Law.
State-by-State Variability
Separately, many states have their own gift bans and reporting laws, some more restrictive than others and each with their own penalties.
It’s common to see signs at catering counters reading, “We’re unable to provide coffee for physicians from Vermont, Minnesota, etc.”
Some exhibitors leave the adherence to those laws up to the HCPs from those states, while others require the HCPs to swipe their badges to verify their state of residence.
How to Handle Exhibit Compliance Issues
Now that it’s clear that exhibit compliance issues are, in many cases, the result of individuals interpreting 30+ years of regulations, handling compliance becomes an activity rooted in knowledge and collaboration rather than fear.
So what should you do? For anyone involved in face-to-face healthcare marketing, the first step is understanding the distinction between:
- What is a mandate (e.g., FDA rules, Sunshine Act disclosures, state laws)
- What is guidance (e.g., PhRMA and AdvaMed codes)
- And how internal compliance officers interpret both
When it comes to giveaways or “reminder items,” always ensure you’re aligned with current guidance before presenting ideas to compliance and regulatory teams. Today, giveaways must be strictly educational — if permitted at all. As noted earlier, some states prohibit any giveaways, regardless of value.
Among the most popular alternatives are:
- Patient education materials, which are typically exempt from Sunshine Act reporting
- Hospitality offerings, such as food and beverages that are available to all attendees
These options provide a compliant way to engage without introducing reporting burdens or regulatory risk.
Working with Legal and Regulatory Teams
The people who interpret the regulations are simply doing their jobs. Their number one concern is to ensure that all promotional activities are compliant, protecting the company from marketplace embarrassment and potentially severe fines. They are not adversaries; don’t treat them as if they are.
In most cases these teams don’t attend medical conventions, so many of their decisions can seem theoretical or disconnected from the exhibit floor reality. It’s up to you to help bridge that gap and educate them about the practicalities of the congress environment.
Here are a few actionable steps to build a more collaborative and productive relationship:
Document Exhibit Best Practices
When you know you’ll be presenting a new idea to compliance, take photos from the show floor to demonstrate common practices and alternatives. For example, one recurring suggestion is to place important safety information (ISI) beneath the product brand name on a hanging sign. However that sounds in theory, it may prove impractical on the show floor. By snapping photos of other exhibitors’ booths to show what these recommendations really look like, you can ultimately guide your team toward feasible and compliant solutions.
Meet Early and Include Everyone
Set up a meeting with the compliance team before introducing new creative or promotional ideas. Ideally, this includes:
- Internal convention staff
- Agency partners
- Any other relevant stakeholders
The purpose is to understand your company’s current exhibit compliance posture. If a recent FDA Notice of Violation (NOV) has occurred, expect a more conservative stance and plan accordingly.
Build in Extra Time
Approval cycles can be unpredictable. Always pad your project timeline to allow for review, feedback, and the occasional revision loop. This will help avoid last-minute roadblocks and preserve production schedules.
And Finally, Some Creative Bravery
According to Tim Hawkey, Chief Creative Officer at the award-winning agency Area 23, pharma is still a very conservative industry, in some ways unnecessarily. He says:
But every year, I feel like the door to creativity opens wider and wider. And every time a pharma marketer makes a brave decision, it makes everyone around them a little bit braver too. [there is] an assumption that healthcare has its own criteria or benchmark for creativity. And while that may be true right now (hey, that’s really good … for pharma), that has to end if we hope to continue to elevate the work for pharma brands.
Creativity is creativity, and when we use pharma or healthcare as a modifier for our creative work, then we’re lowering the bar to meet us where we are. Instead, let’s leave the bar where it is and stretch ourselves to meet it.
Working with compliance does not mean that the work should not be original and thought-provoking. In fact, understanding the parameters of the regulatory environment defines the field of play and allows agencies and brand teams to deliver high-impact creative to play their best game.
It is challenging to craft an educational promotional message that is engaging and effective, much more challenging than, say, handing out golf balls as exhibitors did in the pre-PhRMA Code days. And today, attendees expect a compelling experience with brands, including healthcare.
Have questions about exhibit compliance? Let’s talk. Reach out to our team for expert guidance on your next healthcare exhibit.
