The event was kicked off by chairperson Antoinette Eber-Roe of AbbVie Inc., who stated, “Labeling is a very complex animal.” Eber-Roe pointed out that creating a successful pharmaceutical label not only requires getting content, but presenting it in the right format and implementing it in a coordinated way - all while maintaining compliance with regulatory agencies every step of the way.
“People don’t understand how important the labeling is,” she said. “In some cross-functional meetings, non-label people don’t understand just how big of a responsibility we really have.”
She added, “We are a critical element of people’s treatment, as well as their healthcare.”
Corey Holstrom – manager of packaging and labeling compliance/formulation and ingredients operations at Pfizer Global Quality Operation – gave the day’s first presentation, titled, “Evaluating Label Compliance to Gain a Deeper Understanding of Complying with the Current FDA Regulations.” Product labeling, Holstrom said, is the number one reason for product recall.
Holstrom was quick to point out that labeling compliance is not limited to text, but also includes artwork. “Both can have errors,” he said. Holstrom shared with attendees just one example of regulatory compliance, which was composed of seven sections, each with anywhere from one to 12 sub-sections. “One mistake in just one section will cause a product recall,” he said.
One example of wording that could prompt a recall, Holstrom shared, involves ages. “Saying that a product is appropriate for children under six, for example, is vastly different than saying a product can be used by ‘children six and under’,” He notes that if a product is intended for use by “children under six,” it means that children up to age five can use it safely. “Children six and under” includes children who are age six; if that distinction is not clear, a product can (and will) be recalled.
The threat of a recall is also very real when marketing materials are not in line with a product’s actual label. For example, Holstrom shared a story in which a product was offered in both red and green liquid formulations. The marketing materials and the labels, however, showed only red liquids. A production line worker noticed that some of the products were green, and pointed it out to others. The company’s art and regulatory departments, among others, had approved all the materials. No one realized that the product label and marketing materials all had to match the actual product.
Underscoring the competitive nature of the pharmaceutical market, Holstrom pointed out that the FDA provides comprehensive lists of both active and inactive ingredients, as well as how those products can be safely combined. “There was an incident a few years ago when a company wanted to mix two active ingredients,” he said. “No one verified that it was okay. Competitors actually called the FDA to say, ‘What changed? Can we do this, too?’”
The creation of a pharmaceutical label requires input from many departments, largely to ensure that mistakes are caught before the label hits shelves. Holstrom pointed out that while more people being involved in a label generally makes for a more thorough process, it also makes for a very lengthy revision process. “Sometimes, there are too many chefs in the kitchen,” he said.
Later in the day, a panel discussion lead by three industry executives (who asked to remain anonymous) addressed the value of considering the label as early as possible in product development. Titled “Strategic Approach to Core Labeling to Optimize the Marketed Label, the interactive discussion emphasized the importance of “starting early and staying patient.”
As one executive pointed out, “When you’re working on labeling in development, its all very much a crystal ball. You don’t know what your drug is going to do, you don’t know what your competitive environment is going to be.”
Considering labeling early in development, the executives said, can help to direct decision-making, inform content and conduct of pivotal trials, and maximize potential to achieve desired labeling claims.
One way to ensure that labeling is considered early in the process is to create a Development Core Data Sheet (dCDS). Creating a dCDS, the executives said, is a proactive process and a structured approach to label creation that “ensures that key labeling claims are considered prior to pivotal trial approval.”
Elements of a successful dCDS can include information on:
• Indications and usage
• Dosage and administration
• Dosage forms and strength
• Warning and precautions
• Drug interactions
• Overdosage information
Another way to approach label creation is to establish a Global Label Team (GLT). Creating a GLT, the executives said, maximizes the effort of the group while minimizing the number of meetings. Additionally, members of the GLT can begin considering international regulations at the earliest possible stage of product and label development, saving time later.
When describing a GLT, one panel member said, “It’s a dance, and you’ve got to get to know your global colleagues very well.”
In order to synthetize all the information acquired and maintained by a GLT, one executive suggested having a “key consideration meeting.” The goal of the meeting is to identify the messages that will support the product label. The questions you have to ask the group, according to the executive, are: What do you have to say, and what do you have to actually support that? “Every person in that meeting…has to say ‘this is what we have, and this is the data we have to support it’.”
The event’s presentations gave all participants a lot to consider, and highlighted the complexities of the labeling market. As one presenter said, “We are a unique breed, us labeling people. We like what we do; we have our fingertips on the face of our company. We’re strategic, pragmatic and organized. We enjoy talking about what we do, and we certainly have a passion for it.”