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
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 Decisio
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
Reviewers may be too easily frustrated with project owners who push the limit on legal compliance. By cultivating a broader understanding that the project owners’ job is to push for as much as they can get and then to anticipate getting pushback, teams can grow more productive even when they disagree.
- Emotionally prepare your colleagues for harmonious work – even when these are harmonious constructive edits
- Discourage “Us vs Them” mentality that can lead people to expect clear winners and losers
- Meet beyond official meetings to clarify and mitigate concerns
All PRC members have additional roles and priorities within your company, and how well they are able to meet their review responsibilities depends on preparation from the project initiator. The more teams lean on expedited reviews, the harder the process gets.
- Smooth out review processes by making PRCs aware of initiator intentions early on
- Get to easier “greenlights” as agencies understand what is acceptable from the start
- Recognize the potential need for rapid changes if an escalation to management did not go well
Thought leaders suggest that what matters gets measured, and, more profoundly, what is measured becomes what matters. What are the most meaningful KPIs and performance metrics for your PRC, and what benefits do they deliver?
- Recognize the benefits of spurring healthy competition
- Compare and contrast KPIs and metrics to see which are best for driving team efficiencies
- Focus on areas of improvement within the copy review and approval ecosystem
You’ve crafted and approved the right message for engagement via your your chosen social media – and now the platform itself has changed how your content will look without you having a chance to determine if it is still compliant. CAPTCHA, data sharing, the continued rise of influencers – all impact how and whether you can respond. These are just a few of the emerging technology and policy challenges facing PRCs. Which will become the most important in the next 2-3 years, and how can you best prepare your team?
- Learn to negotiate with IT, digital, and compliance teams, and how their priorities will differ from commercial teams
- Scope out the most important changes involving working with speaker bureaus, podcasters, and influencers
- Recognize where your team needs to learn more about the FTC, BBB, NAD, privacy laws, anti-kickback laws and new OIG enforcement
It is too easy for PRC meetings to become places people go to complain. Members need to be accountable for their contributions to the process – and this gets more likely if you have coordinators playing regular and conspicuous roles, setting SOPs and holding team members to them.
- Emphasize the right skill sets and personality requirements for coordinators
- Aim for coordinators who can manage processes and accept multiple perspectives
- Gather coordinator input on team training, communication, and recruitment
If a process deviation takes place, how do you capture what happened and who is responsible for documenting and reporting it? And at what point must you notify FDA of a mistake that could impact promotional materials?
- Recognize that PRC quality may be guided by people who do not have formal quality backgrounds or experience with CAPAs
- Hunt down root causes
- Assign preventative actions
Particularly for newer companies launching their first products, it can often feel like there are more positions than people. As people reevaluate their career choices in light of COVID, you may find it harder than ever to get the right players in place for brand planning and launch management.
- Work around the mindset of newer companies that may want “just in time” hires
- Build PRC systems around the review time available
- Grasp whether an Accelerated Approval timeframe will influence both your review cycle and your hiring window
It is important to create PRC tools, guidance documents and system enhancements that set up your commercial teams and marketing agencies for success. Adhering to guidance documents requires making the right choices in establishing and sticking to key performance indicators.
- Emphasize governance and collaboration among key stakeholders
- Review the best Communication and Process Guidance tools
- Target the most impactful measures of PRC success