One of the least appreciated disciplines in Drug Development is the development of the product label. The label is one of the most important documents in the regulatory dossier, distilling years of nonclinical and clinical research into a concise, publically available summary of information for the prescriber and patient, to enable the safe and effective use of the product. This key document is also the basis for promotional claims.
Many organizations only really focus their attention on the labeling towards the end of pivotal studies, when preparing the product dossier. Unfortunately, at this point in the development lifecycle, opportunities to create the optimum label have already been limited. The die will already have been cast and the only remaining activities for labeling teams are interpreting the data, summarizing the results, and developing the labeling following the applicable competent authority requirements, formats/templates and schedules. The label will only be as good as the data AND the study design; designs which in most cases were finalized months/years back. So, if at this point, the commercial team decides they want to make claims which had not been discussed before, it’s quite likely that the data from the studies and the resulting label will not be able to support them. The labeling team might then find itself in the cross hairs of commercial teams and/or executives/senior leaders who may be advocating for statements which cannot be supported, not because the product does not work per the wished-for statements, but because the data needed to support these claims was not generated and studies were not designed to collect the requisite information to make the case.
Issues that may lead to a sub-optimal label such as inappropriate primary/secondary endpoints, bad study designs (non-inferiority versus superiority claims), etc. can often be chalked up to lack of labeling discipline. Commercial, Project, Submission and Labeling Teams may be frustrated at the end of the development program because they followed standard operating procedures to a T; there were no audit findings and/or compliance findings; the studies were successful; and yet the label does not support the desired promotional claims. Findings from –lessons-learned activities usually point out that:
- The label was not considered at the beginning of the development program
- The Target Product Profile was not clearly defined
- Commercial, Clinical, Medical and Regulatory were not aligned on the optimal label
- Not enough information about competitor labels was known
- Studies were designed independent of commercial, health economics/outcomes research input, etc.
So, what are the characteristics of a good labeling process which organizations must strive to attain? A well-executed labeling process is comprised of:
- A deliberate and well-planned competitive analysis at the beginning of a development program
- Alignment of internal cross-functional input and external information into an achievable labeling strategy and Target Product Profile
- An effective iterative and continuous feedback loop and adjustments as data are collected. Provides direction and focus which may identify the need for additional studies, especially when the pivotal studies are being planned to consider competent authority requirements, feedback, and precedents.
- The internal cross-functional all hands-on-deck work to develop a core data sheet, containing all essential efficacy and safety data for the product. The core data sheet should ideally be developed in parallel with the development of country/regional specific prescribing and patient information, to establish the company position on the product data before the first filing is made and facilitate consistency of product information across multiple markets.
- The coordination of submission activities and internal preparations and planning for implementation of approved prescribing and patient information
So, if you work for an organization that consistently churns out labels that are envy of the industry/therapy area, please thank your labeling professionals the next time you see them! If on the other hand, your organization routinely has labeling issues and commercial teams are always complaining that they aren’t meeting their targets because the label is not optimal, it might be time to put more effort into developing discipline in your labeling process!