Whether a label change is the result of a new / revised indication, safety change, or annual reportable change, it can have a huge impact on your promotional processes and materials; companies must be well-prepared to handle this. Proper communication across multiple departments, agencies, and particularly collaboration with marketing operations, is key to execution and implementation. The plan for change must consider the timing to update of Important Safety Information, material work in progress, communication on the 2253, managing print assets, upcoming major meetings, etc. Additional materials management and strategic considerations must also include original expiration dates of affected material, scope of other non-label changes to marketing materials, audience, and promotional priorities.

• Identify timing considerations for implementation based on the type of labeling change
• Specify how a cross-functional team supports the timing for implementation timing and implementation
• Map other considerations that affect timing, effort, and complexity of the review planning process

Whether a label change is the result of a new indication or safety warning, it will have a huge impact on your promotional materials and PRCs must be well-prepared to handle it. Proper communication across multiple departments is key.

• Recognize areas where smaller pharma companies need to learn more
• Specify exactly where AdPromo colleagues must get involved – and what they must provide to other team members
• Sequence the proper input from other departments

Repurposing your asset library and targeting different versions can be a more efficient way of working – but will require a broad change in strategy, including in how you engage with creative vendors and agencies. With a dynamic product engine, you can more easily break your output into smaller pieces and recombine them.

• Create a new level of continuity among marketing materials
• Dissect assets into smaller components you can leverage further
• Make platforms talk to each other so you can avoid introducing more complexity

As first reviewer, you put many comments on a piece – but the owner may want you to “stick to your lane” so they can see what they can get away with. If you don’t raise as many comments as you see fit, can you assume other reviewers will – or is there a chance they will miss some?

• Learn from disagreements about who should be making comments about specific topics
• Set expectations for whether comments can be removed and re-inserted by others
• Aim to keep PRC members from feeling disregarded

Remember when social media only meant Facebook and Twitter? Now faced with a much broader galaxy of platform options, including many aimed specifically at younger users, PRCs need to be more diligent ahn ever about maintaining compliance and adapting to changing technologies and user habits.

• Constantly update your approaches to compliant promotional and medical information
• Review newer platforms such as Instagram, Doximity, TikTok, and others
• Account for user comments and invitations on a wide variety of platforms

In early 2023, the Better Business Bureau’s National Advertising Division surprised the industry by releasing its recommendations to remove claims from consumer drug advertising – and the targeted company complied. What is the likelihood of future judgments by BBB, and can they influence FDA actions?

• Review background of BBB’s National Advertising Division
• Grasp the technical challenges brought by Eli Lilly against Novartis
• Understand the implications and questions raised by the Final Decision

The accelerated approvals process is consistent across therapeutic areas – but non-oncology areas have far less experience and need more detailed training. Learning the right lessons from rare disease success can guide product roll-outs in other areas.

• Clarify the materials that you can use at launch
• Outline key post-approval processes
• Anticipate what submissions are required under Subpart H

The change from print to digital has yielded far more demands for information that reviewers must have in order to evaluate a piece. When working across diverse digital platforms, reviewers must understand – and material owners must explain – exactly how and by whom the piece will be viewed.

• Learn from unique experiences with social networks and podcast influencers
• Gauge the level of exposure of the piece and whether it will all be from among your intended audience
• Set strategies for dealing with audience comments and adverse event reports