Trade shows 101: First, Obey the (FDA) Rules!
June 19, 2018
Dear House Rules,
I was talking to a colleague with another pharma company recently who told me that they had violated a rule set by the Office of Prescription Drug Promotion (OPDP), a division of the FDA, with a convention panel they displayed at a trade show. The president of her company received an enforcement letter from the agency, and if they hadn’t corrected the issue quickly, they could’ve had to pay a large fine or even been banned from marketing the product. I’m new to the world of trade show drug marketing — how can I ensure I don’t make any OPDP guidance mistakes?
Good Booth Behavior
Dear Booth Behavior,
First off, kudos to you for taking a proactive approach to this important, but often overlooked, issue. Many novice trade show marketers are solely concerned with booth size, convention floor placement, exhibit functionality (since the vast majority of exhibits involve cutting-edge graphic presentations, customer interactive activity,) and/or immersive experiences. It is equally vital, however, that you put forth an exhibit that is compliant with FDA regulations, no matter what format it’s in.
The OPDP, acting as an arm of the FDA, has increased its targeting and enforcement of exhibit booth content in recent years. Under the Federal Food, Drug, and Cosmetic Act, the FDA has authority to take enforcement action against false or misleading “labeling,” which is defined broadly and reaches everything from exhibit booth panels to company website content.
It only takes the expense of sending one member of the OPDP team to canvas an exhibit hall, and the FDA can cover dozens of companies’ booths in just a matter of a few hours. As a matter of fact, 50% of the OPDP enforcement letters sent out in 2017 addressed violations uncovered at trade shows. Avoiding these violations is not too difficult, actually; here are some actions that could get your company noticed — in a bad way:
- Failing to present any risk information on booth panels
- Failing to present the full indication for use (including limitations of use)
- Placing risk information on a side panel several feet away from the principal display panels
- Placing information disclosing the limitations of product benefits near the floor rather than at eye level
There are plenty of other rules and regulations to follow for both drugs and medical devices, but the principles behind them all are the same: simply be honest. No marketer wants to highlight that there are negative aspects of their product, but in the pharmaceutical industry, it’s a must — and for good reason. It’s mandatory that marketing materials, wherever they appear or in whatever way they are distributed, have “fair balance,” which is simply an equal emphasis on and amount of text regarding both positive/promotional information and those traditional “fine-print” warnings about side effects, complications of long-term use, drug interactions, etc.
Since the variables regarding such laws are endless, the best advice here is to enlist the help of your exhibit house — and your own internal regulatory and compliance departments — to ensure your exhibit is up to code for each show it attends. At Xavier Creative House, we’ve created innovative, buzz-worthy, and compliant exhibits for many of our clients, and we’d love to do the same for you. Call, email, or contact us via social media to find out how we can help you meet your trade show goals!
References: 1: https://www.pm360online.com/exhibit-displays-beware-the-fda/. Accessed June 7, 2018.
2. http://www.exhibitoronline.com/topics/article.asp?ID=1403. Accessed June 7, 2018.