OPDP has just begun enforcement on the CCN rules, with a particular focus on making sure audio content matches visible supers. Does your team have full clarity on just how closely they must match?
- Analyze whether both pieces must be identical or if repeating keywords is sufficient.
- Observe whether OPDP enforcement has changed.
- Grapple with the broadcast and budget implications required by longer, wordier commercials.
How much does OPDP use specific research topics to support the thinking behind enforcement actions? Even experienced PRC teams may not realize the closeness of the two. While making sure to get medical and legal colleagues involved, it is crucial to knowledge-share what OPDP is researching and where that may be leading them.
- Recap the multiple recent studies on DTC TV ads.
- Evaluate both the real level and FDA’s perceived level of whether viewers understand clinical endpoints as explained by commercials.
- Determine the most likely pending enforcement trends.
When adapting to recent SIUU guidance, it can be difficult to determine how best to guide commercial colleagues in leveraging data. Each company may have very different acceptable levels of risk, and it may even vary among product teams in the same company – so what are the most important lessons you can draw?
- Analyze the potential for including off-label data.
- Choose the best publications and conduct the fullest possible review.
- Recognize when individualized data points can indicate broader trends.
Whether we are evaluating a recent OPDP enforcement letter or an internal proposal, it can be important to understand the regulatory landscape that surrounds us. Using a few recent OPDP letters as case studies, this session will look beyond the letter and explore environmental factors that may contribute to regulatory scrutiny of promotional communications.
- Discuss key questions to ask and facts to collect based on OPDP enforcement examples.
- Identify and learn from enforcement patterns.
- Explore novel promotional communication concepts.
Do your materials for national sales meetings or training sessions need to be vetted by the full committee? And if you decide the answer is yes, will your team accept this or will you get pushback?
- Evaluate the pros and cons of formal review for internal documents.
- Weigh whether there is a cutoff for inclusion in PromoMats.
- Understand when prior jobs have set expectations for or against internal-use reviews.
By properly handling personality differences, you can minimize conflicts within teams and foster a more collaborative environment. It can be worthwhile to set aside devoted resources for moderated workshops that resolve differences and prevent policy disagreements from worsening.
- Run through sample scenarios that emphasize speaking candidly without emotions or anger.
- Emphasize the importance of hearing even the most broadly differing perspectives.
- Acknowledge the types of attitudes and approaches that can cause roadblocks – and how to address them.
Escalations are more unpleasant when PRCs feel they are not properly notified. Regular communication with managers and specific clarity on who gets involved at higher levels can help keep things orderly and lower apprehension.
- Put together a scenario checklist that will leave no doubt when you have reached the threshold for escalation.
- Clarify the processes, timeframes, and personalities involved.
- Encourage team members to keep channels open with their management.
The rise of automation and AI in this space can directly impact the marketing coordinator role. What new risks and opportunities will your team face if the human element is lessened?
- Evaluate the likelihood of AI recognizing and properly handling a first-level submission.
- Keep realistic expectations about where AI is likely to go in your processes.
- Consider ethical and legal implications of AI-driven materials – and who owns them.
- Build the best messaging around meeting clinical endpoints.
- Develop a toolkit for information releases before a product is launched, or even before it is named.
- Plan to build product awareness and momentum while maintaining best practice on commenting and archiving.
To maintain an efficient system, you can’t sacrifice your process too many times or else you will miss deadlines. You may naturally want to give more help to a teammate who is in need of more attention, but if you overdo this, your reviewers will run out of time. How can you stay neutral within the scope of your operational role, and not sacrifice the process itself for the sake of helping out?
- Build the soft skills necessary for appropriate time management in different relationships.
- Internalize that no one gets a “pass” on your mission.
- Keep the compact of your process in mind at all times.
- Fuse the expertise of both teams on co-promotions.
- Build awareness of the new methods for review escalation.
- Clarify how to make decisions on higher-level bodies.
It is easier said than done to balance the speed of rigorous approvals while maintaining compliance checks. While you always want to expedite and automate some steps, the concern is whether potential problems will be overlooked.
- Walk through the expediting procedures that work best for you
- Weigh the pros and cons of a 7-day turnaround (compared to usual 31)
- Explore options for automation on PromoMats and other tools
The current hiring market has flattened, but it can still be difficult to get new talent with the proper skill set. More important than long regulatory experience is whether a team member truly understands commercial partners, levers and drivers, and has good communication skills.
- Learn the indicators of when team members understand risk but not how to communicate it to the product team.
- Anticipate the extra training needs when colleagues from a traditional medical background move into regulatory roles.
- Recognize what does and does not work when communicating risk.
The more rounds your review goes through, the more the brand teams will be interested in performance metrics. While this can make them feel empowered to “call out” team members, if utilized properly it can also lead to healthy and productive competition.
- Emphasize framing the metrics in a non-hostile manner.
- Be clear on the warning signs of personality clashes.
- Practice isolating quality and speed issues in ways that build teams without building tension.
