Pharmaceutical and biologic companies are evaluating recent court outcomes (such as the Amarin and Pacira cases) on promoting off label (or expanded or subpopulations) use, using other than the historical interpretation of substantial evidence data. As companies are determining their promotional path forward, they are taking into account the continued requirement to promote in a truthful and non-misleading way, as well as the use of disclaimers. Clearly, there is an industry interest to distribute these data.
However, as companies are evaluating these cases and their interest in data use/distribution decisions, it is also imperative to consider the possible long-term consequences of these decisions.
The following considerations are not all inclusive, but are some of those that must be contemplated as part of on-going deliberations:
- Liability considerations – Will the type, level, and quality of data the company shares proactively put it at greater risk for liability challenges? If so, is the company willing and able to defend these suits?
- Competitive considerations – As the FDA is taking substantially fewer promotional enforcement actions, is the company prepared, both from a will and resource perspective, to handle competitive promotional challenges? Is the company prepared to bring, and defend, Lanham Act suits? Will the company hold itself and competitors to the same data standard, and how will that be defined?
- Payer considerations – At a time when payers are expecting higher quality data, including comparative data, will the quality of data the company provides meet these expectations? What are our expectations for our company’s competitor’s data quality? What internal requirements do we create for promotional data and how do we create executional uniformity?
- Additional Governmental Agency considerations – What is the company’s overall marketing strategy, and how might other agencies (such as the DOJ, SEC, OIG, and the states) view this use of/distribution of data in the overall promotional context?
- Reputation considerations - How important is the company’s reputation with stakeholders? Will the company’s (and product’s) reputation be harmed by the promotional decision?
- Millennial authenticity considerations – Understanding data regarding Millennial promotional expectations, such as authenticity and transparency, will the company’s overall strategy for communicating this data build trust and long-term support with Millennials? If not, what are the long-term consequences for alienating the Millennial consumer base?
The decisions surrounding product promotion, and the evidence required to do so, are challenging for all companies. Each company must carefully consider not only short-term potential gains, but also fully assess possibly damaging long-term consequences.