How to learn about healthcare product labeling and why it matters for regulatory professionals

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“It all comes down to labeling. It is all about labeling.” 

So says Cathleen O’Connell, architect of RAPS new Online University course Pharmaceutical Labeling: Introduction to an Essential Function. She’s also the author of Essentials of Healthcare Product Labeling, a RAPS publication that dives into the subject. Cathleen has more than 20 years of experience in healthcare product labeling as both a practitioner and an educator. 

O’Connell joined RAPS for an interview on healthcare product labeling, RAPS’ new Online University course and more. This conversation has been lightly edited for clarity. 

What is healthcare product labeling and why do regulatory professionals need to know about it? 

Just to give a general introduction to healthcare product labeling, you must think about it in terms of what it is, who writes it and who reads it. 

And it's more than just one thing. It's a whole family of entities. But the basic purpose is—it's the informational component of a product; it's the identification; it's the words; it's the graphics; it's the branding. It's printed as physical components, or it's electronically disseminated. It's a family of manuscripts in various languages, various formats, various versions—for whatever reason. It's fliers; it's websites; it's cartons of labels. So that's what it is. And that's the heart of the importance of it. Because a product without its information, how to use it and information about benefit-risk and help selecting the proper therapeutic item, is useless.  

It goes back to the whole comment by, I think it was Paracelsus: The difference between a poison and a medicine is the dose. Well, how do you know what the dose is without the information component?  

Who writes it is typically the sponsor of the product—the manufacturer, sponsor or the developer. And it's approved by the health authority for that region for everyone using the product because we're not talking about the dispensing label. The dispensing label is overseen by, in this country anyway, the boards of pharmacy. And that's for the labeling; that's information for a particular patient written by a particular prescriber, if it's a prescription therapeutic. So that's not the focus of this course. The focus of the course is the information about a healthcare product that's developed by the sponsor. And who reads it depends on the purpose of the information. 

It’s unique in the submission documents for a regulated product [because] it’s publicly available. It’s written, even though it’s approved by the health authority after negotiations with the sponsor, it’s written for the user. The prescribing information is written for the healthcare professional. If there is patient-oriented labeling, that is written for the patient. It goes back to that there is a whole family of components. 

Speaking of RAPS new Online University course, you’re the author. Why was this course necessary and what do you think regulatory professionals will get out of it? 

The course focuses on, as I said and as I feel, the most important culmination of drug development . It's a culminating function of drug development, is labeling. So, everyone involved in the regulation of healthcare products should be familiar with the function, no matter how involved they are with it.


What I want people to know about the course is that labeling is a dynamic field. Things are always changing and evolving, so the course is meant to give everyone a general appreciation of what to know and, if they're working in or with labeling, where to find information. 

And ideally, we'd like to spark some interest in the topic so that they can explore further and dig deeper. And we provide resources to do that, including referencing the textbook, which has a little bit more comprehensive detail for each of the subsections. 

Why is healthcare product labeling an important topic for regulatory professionals to know? 

It's an important component of the product; and it is submitted to health authorities for approval. So, the regulatory professionals need to understand how they can meet the expectations of these health authorities by knowing that labeling is data-driven, and that the evidence that is presented needs to support the claims. 

You can't go beyond the claims and labeling for benefit-risk, proper use and all the details, unless it's endorsed by the interpretation of evidence. You can also use labeling as a guide to drug development by laying out the claims that you want, and then considering what development you need to do. That's a concept that had some [credence]  earlier on in this century—target-labeling—as it’s called, using the labeling as a roadmap to development, essentially. And then that would be discussed with the health authorities. Not to get any guarantees on language, but to help with the strategic and efficient use of resources in the development of your product.


What might be the toughest challenges for someone who’s new to regulatory affairs or to someone who’s unfamiliar with labeling when they first start learning about the topic? 

The challenge is that it all comes down to labeling. It was always my motto: It all comes down to labeling. There are just so many touchpoints. And I guess on first blush, it would seem overwhelming. It's an onion with many layers, and there's so many documents and components and versions and activities because there's so many users and so many touchpoints. Users inside the company, the company and the sponsor company, as well as external [users]. And so many touchpoints along the entire continuum of drug development from NCE declaration and all the way through to sunsetting it and discontinuing registration. 

It's just so much and it can be done [but] on the surface it's just another regulated aspect of drug development and drug management. It involves things like version control, document management, proofreading, all kind of dull things. But there's some major drama every day and it is kind of refreshed by the fact that it's not a harmonized component. There are regional versions; there are always issues for global products. 


So, I'd say on the surface it seems dull. But, if you peel back the onion, it can be very interesting. And one thing that’s a common problem to highlight is the need for careful communication. You can't just speculate about what would be appropriate wording in a language and in the label without looking at the data and really vetting that, because emails and things that are immature speculation come back to bite companies in liability actions. 

What’s different for beginner-level regulatory professionals learning about labeling compared to a veteran who might be looking for more information on labeling? 

The person who's new to regulatory issues and labeling would need to learn all that labeling involves. It's not just one document. Very often we have colleagues from other parts of the company who are, well— “just write the label and I'll see you tomorrow afternoon and you'll have it done.” It's way more than that. 

And it involves contributions from across the company and it involves a whole host of documents and components. So, there's way more to go. But as far as a seasoned professional who knows about the labeling game and really what it's all about, then I would say that the endlessly refreshing aspect of what's different about each project is that each project is a product in development. 

You also authored a book about labeling. What do you think someone gets out of the course versus the book? What might be some differences in who might be taking it or what they might get out of it? 

I think the course is a higher-level introduction and an overview. And it grounds you, as I describe it, in the function, and gives you a taste and an appreciation of the of the scope of the function; and then sets you free to go and explore further. 

And the textbook, which is also at an introductory level because you just can't get too deeply into such a dynamic field, is much more comprehensive. It does provide more details about the different labeling, the different regions and the different audiences, and all of that. And a thousand more references. So, that's for the people who've taken the course and say: “You know what? This is pretty interesting; and I think I'd like to learn more.” 

Pharmaceutical Labeling: Introduction to an Essential Function is available now. 


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