Companies attending large medical meetings to showcase innovative and marketed drug products alike should beware that the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) 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.
Large medical meetings and conferences have become relatively low-hanging fruit for the FDA in terms of providing fertile ground for identifying instances of both impermissible pre-approval promotion of investigational drugs and violative promotional claims and presentations for marketed drugs. After all, 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. In fact, OPDP enforcement letters addressing exhibit hall content have totaled:
- Since 2015, 23% of letters
- Since 2016, 29% of letters
- Since 2017, 50% of letters
In addition, two out of six (33%) of these letters going back to 2015 were warning letters, with both warning letters relating to approved, marketed products rather than investigational drugs. This suggests the FDA may be cutting drug developers with investigational products some slack since they may be somewhat unfamiliar with the FDA’s authorities. In its letters, some of the key violations the OPDP noted include:
- For investigational drugs: Using a proprietary name throughout booth panels without noting the investigational status of the drug and presenting conclusions (e.g., “superior,” “delivers optimal activity”) prior to the FDA approving the drugs as safe and effective.
- For marketed drugs: 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, and placing information disclosing the limitations of product benefits near the floor rather than at eye level.
After sitting in on many promotional review committees myself, I know that these missteps easily would have caught the eye of a seasoned reviewer and potentially prevented these enforcement letters.
While OPDP enforcement letters have been on a years-long decline now, the data indicate that medical meetings are gaining visibility in the FDA’s enforcement focus. Having personally worked with many drug developers and marketers over the years, I frequently see exhibit panel and booth material preparation occurring with last minute, rushed reviews up against tight printing deadlines. Given the increased scrutiny that exhibit booths have received from the OPDP in recent years, advance booth planning and careful booth content review need to be the new rules of the road for both drug developers and marketers alike. With many major medical meetings ahead this year, companies should plan early and engage careful review of any booth content they plan to present.