In recent court cases regarding off-label promotion, including the Amarin case, the rulings have upheld the regulatory standard of truthful and non-misleading prescription drug advertising/promotion.
That being the case, what is misleading? How might FDA and the product liability plaintiff attorneys define misleading in all promotional contexts? This question has both deep, and broad, implications. In light of those court cases, as the biopharma industry considers future promotion, companies are meticulously examining the definition/interpretation of misleading to ensure compliance with legal and regulatory standards.
It would also behoove the industry to strongly consider other agencies and interested parties in these deliberations, such as: the DOJ, HHS, OIG, the SEC, the states, and even the payers. These agencies and groups are concerned about the overall marketing strategy and impact from a reimbursement and shareholder perspective, and might well subsume this type of data presentation as an indicator of a broad strategy. It is essential to understand their definition of misleading in the larger context.
In the recent court rulings/FDA context, “not misleading” might be defined as stating the information found in a single published study completely and correctly. But is that enough?
Look out your window. Pretend it is pouring rain – a true torrential downpour. A friend who is en route to your house calls to inquire about the weather. You accurately read the complete weather report to her that states it will be a gorgeous day - no rain predicted. However, you are looking at a flood outside as the rain continues. Though you may have read the weather report “truthfully,” your verbal message is certainly misleading in the overall context of the information.
Clearly, this is an oversimplification and something no one would actually do. However, this example raises significant questions about misleading, both in the context of one data set, and in the greater context of overall data and promotion. The list below is far from complete, and is not intended to reflect any specific case, but provides a start for the broader conversation regarding misleading.
- Is the study designed appropriately, adequately powered, statistically significant, and clinically relevant to support all of the conclusions (indications, patient subsets, quality of life, patience adherence, etc) used in promotion? If not, might the conclusions be considered misleading?
- Is the promotionally presented study data representative of the complete study data set, or is “positive” data selectively presented? If the later, might the claims be considered misleading?
- Is the promotionally presented study representative of the known universe of the data for this claim, or is this study selectively chosen due to the positive outcomes when conflicting data exist? If the later, might the claims be considered misleading in the greater promotional context?
- Is the promotionally presented study one about which FDA has provided guidance on either design or data interpretation flaws? If so, how does that impact the assessment of misleading?
The questions surrounding drug promotion are complicated. They become increasingly complicated with individual court rulings. It is vital to remember the decisions are made on individual cases, each with special circumstances. The decisions may or may not be applicable broadly or to other specific considerations. Perhaps the best way to determine what is misleading is also the easiest way. Though drastically oversimplifying again, if we have to spend hours, days, weeks determining whether or not something is misleading, isn’t it?