She says ‘labeling is where all the action is.’ Let her explain.
Labeling is a critical element of any healthcare product. It’s also an underappreciated corner of the regulatory world, says Cathleen O’Connell, PhD, MS, RPH, the editor of Essentials of Healthcare Product Labeling, Second Edition.
Cathleen spoke to RAPS about her “labor of love” creating the second edition of this book and explained why labeling is “where all the action is.” This conversation has been lightly edited for clarity.
Essentials of Healthcare Product Labeling, Second Edition is available for purchase here.
Why did you decide to get involved as the editor of Essentials of Healthcare Product Labeling? What is it about product labeling that you find fascinating?
It was really a labor of love, from the very beginning. I have spent the better part of my career as a labeling professional. So, I recognize the importance of labeling to the safety and efficacy of healthcare products. Labeling is just as important as the product itself in most cases. It's a public-facing component. Labeling has a range of users for different products for different reasons. It's an impactful regulatory function and deliverable. I also specialized in communications for another part of my career, so I know the skills that are needed and the challenges that you encounter in trying to create and manage information that's understandable for the target audience.
The first edition of this book came about because I know this very specialized corner of regulatory is underappreciated, even by colleagues that work with labeling. What they don't realize is that labeling is where all the action is. It all comes down to labeling.
This book is really a campaign to raise the visibility of not only everything that the labeling function entails, but also the overall importance and the critical nature of what these labeling professionals do. And I know that all of the contributors to both editions have felt the same way. We want to amplify appreciation for labeling and the people who are involved in the function.
How did you approach your work for this new edition of the book? What was the process like getting this big project to the finish line?
Some regulatory changes that we anticipated while creating the first edition of this book had finally come about, making this the ideal time to go back to update and refresh the content. There were also a few new topics we wanted to add and expand into to make sure we told the whole story of labeling.
We started out by mapping out the desired content, including the new topics, and then recruiting professionals who are experts in their area. It was important that they all have this practical, fresh experience. Our authors reviewed all the content and updated the existing chapters, checked the references, and the links. Companies and health authorities are notorious for changing where the URLs go to and where resources wind up.
Some chapters are entirely new. Some of the topics we had a little bit of content on and we wanted to expand, and some were brand new. We want to tell the entire narrative of labeling, the whole story. So, we structured it in with a logical flow from the foundational concepts and basic principles all the way through to the chapters that focus on certain regions and certain specialized products.
I want to underscore that the second edition is entirely refreshed and benefits from the contributions of a number of new contributors who took a fresh look.
For some people who might think of labeling as mundane, why can labeling be such a politicized thing?
One of the things we do in this book is reveal drama and excitement involved with labeling, because there's always something going on in labeling. There are the “small p” politics of interpersonal interactions in organizations, but really because of the nature of the function and the public-facing exposure of the deliverable, labeling sometimes gets buffeted by the headwinds of politics with a capital P. There are some examples where that has affected some major labeling initiatives with implications for public health. I can give two examples that I was directly involved with and observed.
The first one is electronic labeling. For decades, there had been an effort driven by a coalition led by industry, but involving representatives of healthcare professionals and even FDA, to eliminate the need to print and package prescribing information with the product. Besides the fact that it's a waste and has implications for the environment and the fact that it's a major expense, printed labeling also lends itself to becoming outdated as it sits on the shelf, while the electronic versions may be updated immediately.
The effort was taking a long time because a lot of research was going into the justification for making this change to e-labeling. But it was halted in fits and starts. We still have to print these things and people can still wind up reading outdated information. That's one example.
Another example relates to written patient labeling. For decades in the US, there has been an effort to standardize a requirement on behalf of quality and consistency and accessibility. There was a proposed regulation by FDA that that was halted in the 1980s because it got caught up in the Reagan administration’s efforts to roll back regulation. That threw it back to a voluntary initiative that was led by industry to improve the quality and availability and consistency that wound up being less than optimal. Of course, there still the effort to progress forward on this and become like other regions and countries where it's more standard. I think something may be in the offing soon, but it's just another example of labeling getting caught on the horns of politics and affecting public health.
What are some areas where manufacturers might make mistakes on labeling and are there some mistakes that might be more common for drug companies versus device companies or vice versa?
The first would be that a good source of information might be health authorities themselves. Health authorities are continually assessing labeling across products. They have a lot of information about quality, about issues. And they're always doing research into best practices and communications and then generating regulations to help shore up standards. So, Labeling is the last document in the dossier that can be finalized, because you could start working on it and drafting it, but you can't finalize it until all of the documents that it depends on are finalized upstream. The summaries, the overviews, and all of that. If they eat up extra time in the project plan or in the dossier plan, labeling can get squeezed because the deadlines for submission are not going to get moved. I'm just taking the opportunity to voice that as a frustration of many of my earlier years.
This edition contains a new chapter was on investigational drug labeling. Why did you want to include a chapter on that now?
The first edition of this book was such a huge endeavor to bring forth from the void of nothingness that we really just couldn't tackle everything. Unfortunately, investigational drug labeling was something that we weren't able to include. But it was a gap that we all had it already recorded, and fortunately we were able to recruit subject matter experts not only to include content on that, but on other specialized topics as well, including the labeling for investigational materials.
Speaking of new chapters, there's another new chapter in the second edition on the labeling and packaging of cannabis products. How did that chapter come to be?
It's a topic that has changed a lot in the regulatory world. There was some cannabis content in the first edition of this book that was included in the US section, because the US is where it's the Wild West, right? It’s where things are constantly changing.
This chapter starts with a general presentation of the therapeutic potential of cannabis and interest in it as a healthcare agent. Then it gets into the evolving regulatory situation. It highlights the independent actions of the various states in the face of federal intransigence over its scheduling. Then, it gets into the initiatives for the labeling and the packaging standards. Then once again, because of the lack of oversight by FDA, the standards are the initiatives were led by industry, basically, and the standards were based on pharma and product regulations and best practices.
I can't see the future, but I do believe that there are some ineluctable trends. One is in the ever-expanding access to cannabis as a medical treatment. Just in general, access to cannabis products and the consequent need for good quality information by its various users, caregivers, as well as the patients. It is such a hyper dynamic situation, and the chapter offers guidance on resources that will allow the readers to stay up to date as things change.
What are some key takeaways you would want someone who's read the book to have?
Number one: labeling is a thrilling place to be. It's a nonstop rodeo of incredible action. There's always something going on. There are always time constraints and stress and high visibility. And senior management gets very, very eager to know whether you're using “must” or “recommends” or “should.” It has touchpoints with everything. As a function, it is always evolving. There's research into effective communication, changes in regulation, technology, and enhanced patient advocacy there. There are all kinds of reasons why the environment that you're operating in changes.
Labeling is anchored in certain fundamental principles. Number one is the needs of the user must be the preeminent focus. It's not the wording that is preferred by the health authorities or what you could get away with for an edge in marketing. It's what would be helpful to the people who will be using this product.
Number two: labeling must be supported by evidence. You can't just say whatever you want, as if you could get away with it. The purpose of the entire dossier is to support the labeling claims.
Another takeaway is that labeling has touchpoints at every stage of a product's lifecycle. We cover the whole span in the book and how labeling impacts various users in different ways. It's a very complex little area. The stakes are very high for labeling. You can see with some news items that it can have a direct impact on healthcare.
Get your guide to healthcare product labeling today.
Essentials of Healthcare Product Labeling is available for purchase here