Your Label Is Being Updated—Now What?

Label Updates and Updating Promotional Content and Speakers: The Good, the Bad, and the Ugly


The Good: The clinical studies netted out positive data for the drug your brand team launched a few years ago. Years of work have borne fruit, and now there are exciting new data to share about an important new indication or administration option. Your regulatory colleagues submitted a new draft label and Important Safety Information (ISI) to the US Food and Drug Administration (FDA) for review.

The Bad: Your brand team has a wide array of print and electronic promotional materials affected by the label update. All materials need to be updated by your agency partners, submitted, and rereviewed by your medical, legal, and regulatory colleagues. Not to mention, all of this has to happen within a 90-day window from the date the final label is approved.

The Ugly: You have already spent a lot of time and money getting the original promotional materials approved. You have a large speakers bureau and already successfully executed another series of live speaker trainings six months ago. Do you really have to go through all of this again?

A label update doesn’t have to be bad or ugly. It’s actually a very good “problem” to have. Through collaboration with an experienced and energized agency partner, updating promotional materials and getting speakers trained on the updated content can be a seamless process and smooth experience, so much so that you might just be ready to sign up for it again.


Here are some critical components of success for label updates:

1. The Master Plan. Proactive planning and diligent preparation prior to getting the final label set the stage for success. Securing drafts of the label and ISI and sharing them with your agency partner will provide helpful insights as to the extent of the label updates and what the changes may look like. It also provides a head start in developing new compelling content and engaging graphics to accompany the new label. Prioritization of which tactics will be updated and by when helps keep you on task and on budget. Internal reviews (medical, legal, regulatory) can be booked in advance, ensuring your materials are reviewed in a timely manner.


2. You Can Never Make It Too Easy for…

…Your Review Teams: Once the label is final and promotional materials are updated, submitted, and reviewed, a truly effective agency partner takes the feedback your review team provides on one deliverable and applies it globally across all deliverables and projects. This builds the trust and respect of your review team colleagues, in addition to making you look really good.

Your Speakers: As they are saddled with professional and personal obligations, speakers can be short on time and attention. An experienced agency partner understands this and views the label update from a speaker’s perspective. Proactive e-mail communication at the time of approval of the final label helps frame what speakers can expect from the brand over the coming months. It also aids with compliance by providing direction on if/how they can speak to the new data prior to being trained on and having access to the updated content. Providing a brief summary of the label updates is also extremely helpful, as speakers may not have had time to review the new Prescribing Information (PI) in detail, yet a program they are scheduled to speak at may be fast approaching.

3. Practice Makes Perfect. Your agency partner should know the label updates better than anyone. They can develop training aids and execute trainings for your internal teams (sales representatives, medical science liaisons, etc) and key opinion leaders who are serving as trainers in advance of the speaker trainings on the updated materials. Your agency partner can assist in “training the trainers” as clearly and efficiently as possible by creating an outline for them to use in their scheduled speaker training programs.

4. Keep It Simple, Smartie. Materials have been updated and approved, so now your speakers can be trained. This type of training can be effectively completed in a virtual setting, resulting in significant time and cost savings. We have found that use of a presentation focused on the key changes across all of the promotional materials vs reviewing all of the materials provides a more digestible and memorable learning environment for speakers. A “Quick Hits” document summarizing the key changes can be a useful resource for those who may have not been able to attend the agency-provided training or for any speaker to use as a refresher.


5. Be Nimble, Be Quick. As the updated promotional materials are undergoing final internal reviews, your agency partner should also be coordinating how the updated materials will be disseminated to speakers so they are able to use them soon after completing training. Use of a centralized repository for all promotional materials available to speakers, such as nControl™, ensures speakers have what they need to present that new exciting data that got all of this started in the first place.