FDA will challenge you to justify your focus on particular claims being consistent with labels, and with the proper strategy you may be able to speed up the label negotiation process.  Your label strategy should not be driven by marketers; rather, medical team members should specify allowable information.    

• Prioritize this during training of new team members
• Broaden the variety of published materials that remain consistent with labeling
• Track how different companies have promoted primary and secondary endpoints
• Seek advisory comment on CFL data

4 out of 5 OPDP warning letters relate to either omitting or downplaying risk information.  Ad agencies may try to push the envelope on this – presenting risk information in a subdued manner, or after a signature block – and moves like that put you at risk.  

• Focus on marketing techniques that have triggered OPDP intervention, including suggesting that readers seek safety data elsewhere or continue reading after the apparent end of the piece
• Consider ways to maintain fair balance in character-limited promotional pieces
• Emphasize that risk information must be visually the same as the rest of the piece

Even if OPDP letters are heavily redacted, they can still provide valuable clues if you know where to look.  A growing trend is for letters to refer back to prior advisory comments to the recipient company.  Can you quantify how often OPDP looks back at their past warnings, and whether this influences their later judgments and penalties?  

• Drill down into the prevalence of commentary regarding prior communications
• Track the sequence and severity of OPDP comments across multiple rounds
• Examine whether initial OPDP feedback results in heightened expectations and harsher penalties

After many years of preparation, submitting promotional materials to OPDP via the e2253 portal will finally become mandatory in June 2021.  What have been the most important lessons from your pilot projects, and what final issues remain unresolved?  

• Determine the need for bringing regulatory publishing in-house to accommodate online submissions
• Find ideal external regulatory publishing vendors
• Spotlight how the reality of this portal process has differed from expectations

Who makes the training materials you use for new PRC team members, and who takes the lead in delivering them?  Training methodologies should help empower new staff to be creative, while at the same time providing a detailed brand portal for claims management that makes it less likely new members will wind up re-fighting battles that had been settled years ago.  

• Prioritize solution-oriented negotiation skills
• Construct mentoring and shadowing programs that provide key resources
• Acknowledge the unique risks of onboarding and turnover around launch timeframes
• Evaluate dedicated training courses

Around major milestones in the product life cycle or the launch of a competitor, there may be hundreds of items per reviewer per month.Reviewers can naturally feel behind and overwhelmed, especially if they are working in pandemic conditions not fully under their control and different than how they were trained.How do you get better inputs in planning, especially for lean times or peak cycles?

• Spotlight the types of pieces that will always take priority
• Devote more time to “central” documents, then check derivatives for consistency
• Evaluate if more days can be added to the review cycle

Well-trained publishing and marketing operations team members can help you narrow down the most efficient PRC methods.  A firmer emphasis on operations can help take the “churn” out of reviews and noticeably benefit your timelines.  

• Discuss  why regulatory publishing serves as a critical PRC component
• Highlight how partnerships with operations can help with compliance and efficiency
• Review pilot projects that gauged PRC performance

Whether two biopharma companies are in a true 50:50 partnership on co-developing and co-marketing one drug, or one company is acquiring the assets and staff of the other, PRC leaders need to carefully map out future changes in their team roster and functions. Changing system access rights and onboarding methods are only some of the new tools that must be at your disposal if a collaboration is to succeed. 

• Compare and contrast the leadership strategies that work best in partnerships and M&As

• Emphasize flexibility for incorporating processes from new partners if they turn out to work better

• Retain the employees most essential for newly-acquired products

The strength and the challenge for PRCs is that they gather expertise across multiple business functions and disciplines.  With such diverse backgrounds, it can be difficult to properly set expectations and to make sure all colleagues fully recognize what a PRC can and cannot do; if they overburden it with substandard inputs or a glut of emergency requests, it will struggle.  Through improved outreach and training, PRC managers can achieve goal-oriented improvements in efficiency and significantly reduce overload risks. 

• 2021-03-24Clearly communicate the need for volume caps
• Walk your colleagues through what works and what doesn’t in expedited requests
• Emphasize the criteria for content-readiness

How long should your PRC debate before it becomes clear that upper managers must get involved?  And how many levels of escalation should there be?  There comes a point where it is no longer helpful to cycle repeatedly around the same topic, but for the sake of maintaining long-term PRC teamwork it is essential that the review elevation process not seem punitive or menacing.  

• Rule out putting reviewers into adversarial positions
• Establish governance that gets the “churn” out of PRCs quickly
• Prepare leadership to make decisions on issues of risk that had caused discomfort

Expanding your editorial team can bring new value to your PRC, as their detail-oriented approach can ward off mistakes that hurt your credibility.  Editors can be particularly helpful in maintaining consistency of messaging while working with multiple advertising agencies.

• Map out global review processes that send materials through different reviewers or marketing agencies but the same editors
• Rely on editors to remember comments and developments across different teams
• Formalize a process that keeps all input to agencies consistent

If marketing and medical professionals aren’t pushing boundaries, they aren’t doing their jobs; however, it is the PRC’s job to keep things realistic, grounding discussion around what has actually been done instead of expanded claims on what potentially could be.  If reviewers are perceived as only rejecting new ideas, it can cause commercial tension – so instead prioritize the areas for agreement.

• Cultivate a collaborative approach and avoid adversarial relationships

• Convey what is possible without bluntly saying “no”

• Recognize and benefit from creativity and commercial drive

Digital asset libraries are a tool that organizations can adopt to store, track and measure the usage of all files that encompass their brands’ creative output and intellectual property.  These assets form a static repository, tracking all licenses and IP, while providing teams with a single source to help streamline content creation and re-use. Creating and managing a robust digital library is essential to streamlining material and review. 

• Build out brand portals with all IP and assets to leverage throughout your organization
• Leverage existing processes to help populate the library and regulate asset usage more closely
• Establish clear paths of responsibility and oversight through training and change management initiatives