From my experience and interacting with labeling professionals around me, I can safely say that 10 years ago labeling development by itself was sometimes very disconnected from the drug development process. When we look back we see a Target Product Profile (TPP) owned by a commercial function with a set of parameters that make a product marketable within a given region or patient population. That was always first. Then a clinical development program was developed.
Was it developed with specifically TPP in mind? Sometimes; were the two tracked and updated throughout the development program? Not often. Let us look at the challenges faced by global labeling operations and how their nature has evolved over time.
When it was time to have a reconciled labeling benefit risk profile, the commercially desired attributes along with the development program did not always match and the final approved label by health authorities at time of market was often different from the TPP.
One of things seen in labeling teams back then was that they came in too late into the process, meaning that the label had to be created 3-6 months pre-filing, during the ‘Phase 3’ development phase. But it was also seen as a tactical and administrative function. That resulted in the labeling group consolidating some content they received from various functions.
Times have changed and we have progressed. These progressions have come through various drivers. We see regulatory change and the physician labeling rule driving not just content evolution but also organizational and internal maturity. These developments have really brought labeling to the forefront of the drug development process. Teams are now being pro-active throughout the product lifecycle starting as early as end of phase 2 with the development of a target product label or target product profile. This really is a pro-actively managed document that picks up from a commercial TPP.
Labeling has also begun to play a key mediator role between the development clinical functions, drug safety, manufacturing, CMC and also commercial. It has really become a lynch pin in the benefit: risk profile development and the subsequent communication cascade.
Over the last 10 years, process integration with up-stream and down-stream stakeholders has become very big and has driven efficiency, clear expectations and transparency.
Lastly, technology has taken a greater foothold in global labeling. As expectation from regulatory bodies like the FDA, EMA have grown over the last decade specifically with respect to process and content control, technology enablers have driven not only bulk operational efficiency but also capability in managing the process.
Into The Future: Realities and Trends
Global Labeling Teams need to keep abreast, if not ahead, of future trends to address future requirements. Continuous systematic reviews and updates of the inter-company roles, processes and systems will be required. Global Labeling Teams will also be key drivers in facilitating these changes across the organization.
- Growing Portfolio and Geographies: Most successful Pharma companies are facing this situation with burgeoning product portfolios and it is a good problem to have. However, the increase in workload for a labeling department to manage especially with a fixed resource pool and to go across different geographies whether it’s Asia Pacific, Latin America is a very acute issue. There is therefore a need for alternative operational models to assist in dealing with this surge.
- Persistence of Social Media: Another factor that has been quite prominently highlighted especially in Pharmacovigilance is the persistence of social media. The key impact here is not just the increased expectations by the healthcare practitioner (HCP) but more importantly the expectations of patients. We are seeing a much more informed and involved patient population. The consumer of labeling information is not just the intermediary but the patients themselves. So there is an expectation that content is readily available through multiple channels which then also creates a content control challenge for organizations.
- Evolving Regulations: Labeling teams will need to keep abreast with regulations like the EMA’s PV regulation of 2012 that really hones in on process and content control and also the FDA revisiting the generic PV/Labeling regulations and the impetus for genetic manufacturers to more proactively manage the safety profiles of generic medicines and other regulations that are coming up in the near future.
- Evolution of E-labeling: Electronic labeling or e-labeling could prove to be a viable alternative to the current system and help to improve operational efficiencies and profitability, while reducing complex and disjointed processes. The FDA has regulated that Biopharmaceutical companies will be required to provide the PI in an electronic file and will no longer be allowed to distribute it in paper form with the packages. They will need to find a way to fit the proposed change into their strategic labeling initiatives.
Patient Centric Label Management
When we look at medical outcomes and focus on the patients themselves, we have to say that the Global Labeling Team plays a key role in that as well. It goes beyond process and content management. I think over the past decade we have matured in that area and these aspects are a given now. We are all expected to have our processes horizontally integrated and being able to manage our content throughout the product lifecycle and not just in labeling. There will be a drive for accurate and timely dissemination of benefit: risk profile information to multiple stakeholders (HCPs, patients, regulators) via multiple channels.
[This post is based on the labeling webinar conducted by Sciformix in collaboration with Xtalks on the 22nd of September titled ‘Optimizing Your Global Labeling Operations – An Expert Panel Discussion’. You can listen to the recording of the full webinar here.]