- Reconsider stances on CFL based on the recent FDA enforcement actions
- Understand the complaints brought in recent Novartis letter
- Review discussions about presenting qualitative vs quantitative data
- Have statisticians at the table during CFL discussions to help evaluate the data and the SASS standard
Most PRCs require seeing finalized pieces before review – which is against the value proposition of modular content updates. Shortening the cycle to a more tier-based structure could work, but is your team prepared for this and can they agree on the necessary steps? Finding the best regulatory signals can indicate how a modular approach would be received.
- Grapple with challenges of 2253 submissions for modular updates
- Work towards more personalized content in the evolving landscape of digital channels
- Incentivize content re-use / adaptation through shortened downstream review cycles
- Establish submission standards to further narrow the scope of review (i.e. what has changed vs what has not)
If you have the only drug approved for a disease state, all of your marketing will come under greater scrutiny and you will face more risk. Even purely scientific articles mentioning the sole approved candidate may be implicitly read as describing you. What is the safest way to advance under such heightened attention?
- Properly balance both disease education and branded promotional items, with necessary safety information
- Review case studies when non-commercial messaging unavoidably mentioned your product
- Track the learning journey through reminder advertising
The debate over off-label communication has grown more complicated due to legal discrepancies between the First and Second Circuit courts, as well as FDA’s evolving standards on sharing Scientific Information on Unapproved Uses (SIUU). What are the areas of legal and ethical risk for your marketing strategies, and how does that risk change when you try more innovative methods?
- Chart what differing court findings mean for your approach to off-label speech
- Evaluate risk levels of innovative marketing strategies, such as research grants, affiliations with patient advocacy groups, and royalty agreements
- Grasp the strategic implications of changing regulatory dynamics – among not only FDA but also FTC and BBB
Giving doctors at congresses a first-person look at how your products act within the bloodstream can be very compelling and valuable – but what is necessary for reviewing this medium for compliance, and how can you be sure the necessary procedures will stick around through high reviewer turnover?
- Visualize the concept reviews necessary for all team members to understand VR messaging
- Share best practice so other product teams – and perhaps other companies – don’t need to do redundant work when familiarizing themselves with VR technology
- Determine the best timeframe for regularly updating and sharing guidance documents
Reviewing mobile website and app interfaces can be difficult and misleading, because screenshots and printouts will not fully capture the patient reading experience and are difficult to upload into your systems. Apps that are designed by outside vendors might have stylistic or organizational differences that raise new risks, or that result in a viewing window that lacks the room for all necessary safety information.
- Analyze multiple presentation options for safety info, such as static, scrolling, slide-based, and pop-up
- Predetermine the flexibility of app designers and whether your safety information will fit into their style
- Archive and convey the most representative possible snapshot of your mobile assets for review
No matter how much you train your agency or marketers, there will always be pieces that push the limits and times you must push back. It takes a delicate balance to stay open to discussion while avoiding red lines – and the longer the back-and-forth goes, the greater the risk of stress and conflict. PRC managers have to go the extra mile to maintain calmness and resolve disputes.
- Provide valid reasons for stopping bold efforts
- Make sure outside agencies know what accountability looks like
- Recognize how risk tolerance varies across different disease indications
It can be hard to maintain full trust among a PRC when not all members are in the same room; it gets even harder if submitters repeatedly bring projects that are urgent and need expedited review. What are the best group approaches for forecasting?
- Find the messaging most effective for reaching marketers
- Steer away from behaviors that erode team trust
- Visualize how to rebuild areas that have been weakened
Many PRC leaders oversee both regulatory and labeling functions, and while they are related it is important to note their different focuses. The lessons that labeling teams learn from FDA negotiations can be directly relevant for promotional review colleagues – and vice-versa. How smoothly do your sub-teams communicate with each other?
Since PRCs can review pieces created from various teams within a company (e.g., Marketing, Training, HR, Investor Relations, Corporate Communications, etc.), it is important for other departments to know who we are, what we do, and why we do it. Our internal teams need to know we are their partners, and we will work together to ensure material created is compelling and compliant. Branding your PRC, developing on-going audience-specific training for current/new employees, and getting your PRC’s name out there are essential elements in building a partnership.
- Use new team logos, business cards, and other resources to raise awareness
- Develop and roll out a training module for sales representatives and commercial-adjacent teams
- Maintain branded team presence at national sales meetings and major Marketing meetings
A Claims Matrix can be difficult to put together and manage, but from a reviewer perspective, it represents a tremendous opportunity for saving time. The past work product of multiple marketing managers can be a good starting point for a Claims Matrix – the hard part is making sure it is up-to-date.
- Spotlight areas where this process can be less burdensome
- Reduce the need for remembering individual outcomes across multiple products and campaigns
Explanatory materials meant for patients, such as drug regimen management or clinical trial expectations, need to stick to language patients understand and not overwhelm them; but getting the essential concepts into an accessible, layman-friendly format while maintaining scientific accuracy is very hard! And how do you convey key safety data quickly to someone who is stressed by a recent bad diagnosis? It can be particularly helpful for patients to hear from other patients sharing the same burdens, and here you will encounter extra challenges related to legal compliance once the drug is actually named.
- Chart the proper review for videos that intersperse both physician and patient voices
- Recognize essential requirements in “ask your doctor about—” videos and clinical trial prep materials
- Clarify your approach for branded videos that cover collaborations between patients and healthcare providers
Coordinators can set agencies up for success by training them on what both the PRC and FDA want. Creating a relationship between the agency and the coordinator, as an additional point of contact, builds more comfort and helps maintain clarity on risk profiles.
- Internalize that each agency has multiple pharma clients with distinct risk preferences
- Build off coordinator skills at proactive guidance between different groups
- Emphasize respect for schedules
Your PRC should hold project owners accountable to process and submission quality standards – and should also empower reviewers to say no. What are the best review platform tools for optimizing communication, and how can you best check in with team members to make sure they are learning the right lessons?
- Touch base with brand and ops to highlight priorities
- Develop commenting requirements in review platform to ensure efficient meeting discussion
- Keep regular meetings with review teams and marketing ops
