CCC Executive Briefing: PRT Efficiency - Turbo Charging Commercial and Compliance Effectiveness
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The document discusses how a Promotional Review Team (PRT) can improve efficiency and effectiveness for companies. It provides data that shows PRTs can reduce waste by minimizing unnecessary rewrites, create metrics to prove the value of compliance to business goals, and increase collaboration between compliance and commercial teams. Specific examples are given of how knowledge gaps and lack of pre-review of marketing materials can lead to millions of dollars wasted each year. The document advocates for PRTs to address these issues in order to both protect companies from regulatory risks and allow their businesses to grow.
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CCC Executive Briefing: PRT Efficiency - Turbo Charging Commercial and Compliance Effectiveness
- 1. PRT Efficiency: Turbo-Charging Commercial and Compliance Effectiveness
- 2. Benchmark Data Demonstrate PRT Impact on BusinessBenchmark Data Demonstrate PRT Impact on Business 3 Quantitative Conference Surveys 2010: FDLI – Oct; CBI – June; DIA – May 2 Podium Presentations 2013: Compliance Congress – Jan; DIA – Feb 5,000 +Certification Test Scores Center for Communication Compliance (CCC) Developed by former FDA officials (‘08-’12) CIA and Warning Letter Analysis Input from industry experts
- 3. A Collaborative PRT Quantifiably Impacts Company SuccessA Collaborative PRT Quantifiably Impacts Company Success 3 Reduce Waste Deliver Metrics Drive Collaboration
- 4. Create environment that protects AND grows the business Reduce Risk (Compliance Effectiveness) Increase Sales (Commercial Effectiveness) Serving Patients and Public Health Healthy Tension A Collaborative PRT Quantifiably Fosters Healthy Tension
- 5. External Forces Regulatory/Legal Risks •Known •Evolving •Emerging Internal Forces Key to Look Inside at What Makes Company VulnerableKey to Look Inside at What Makes Company Vulnerable 1. Rewrites 2. Schism 3. Relevance • Reduce Waste • Create Metrics • Increase Collaboration
- 6. The Cost of Knowledge and Process Gaps In the MillionsThe Cost of Knowledge and Process Gaps In the Millions - Regulatory Knowledge Gaps - Promotional Review Process Gaps Intense Compliance Oversight Promotional Review Rigor $2M+
- 7. Hidden Vulnerability #1: Regulatory Knowledge GapsHidden Vulnerability #1: Regulatory Knowledge Gaps 40 hours lost monthly by Regulatory due to rewrites of promotional materials submitted by promotional agencies without proven acumenMore than 25% of one person’s time is lost to rewrites ● Doesn’t include time lost by Legal, Medical, Compliance or Marketing forced to handle rewrites 15 people combined from these functions = $1 MM waste annually
- 8. Agencies spend $100K - $150K annually on rewrites of own noncompliant materials Hidden Vulnerability #1: Regulatory Knowledge Gaps (con’t)Hidden Vulnerability #1: Regulatory Knowledge Gaps (con’t) ● Based on the number of agencies, this can cost up to $1MM/brand or more annually ●Doesn’t factor in regular agency fees for material/campaign development
- 9. Why so much waste… ●Marketing and agency professionals (even senior executives) are not knowledgeable about basic regulations ● Communicating risk, reminder/disease state awareness ads, spokespeople Vulnerability #1: Regulatory Knowledge Gaps (cont.)Vulnerability #1: Regulatory Knowledge Gaps (cont.) ● Marketing/agencies disagree with Regulatory on how to implement key initiatives within compliance ● Digital and PR (media tours, releases) ● Promotional education (speaker’s bureaus, slide kits) ● Ad Boards
- 10. BrandBrand PlanningPlanning BrandBrand PlanningPlanning ConceptConcept ExecutionExecution ConceptConcept ExecutionExecution PRCPRCPRCPRC No opportunity to filter out non-negotiable, noncompliant elements BEFORE submission RevisionsRevisionsRevisionsRevisions TacticalTactical ExecutionExecution TacticalTactical ExecutionExecution Rewrites increase Slower output Vulnerability #2: Agencies (& Marketing) Need Pre-ReviewVulnerability #2: Agencies (& Marketing) Need Pre-Review
- 11. Vulnerability #2: Not Every Reviewers is Seasoned (e.g., New Hires)Vulnerability #2: Not Every Reviewers is Seasoned (e.g., New Hires) ● Dozen plus review parameters can determine if piece is compliant (200+ queries = core) ● Review comprehensiveness/efficiency easily derailed: ■ Typically go line-by-line during in-person review meetings – would benefit from a “Heat map” to prioritize disagreements ■ Spend time looking for government documents to prove their point – would benefit from easier access ■ Experience redundancy/duplication of comments – would benefit tools that help reviewers “swim in own lane” without silos ■ Level of review experience – new hire, junior
- 12. 1. Leadership and commitment by senior management 2. Alignment between promotional regulatory compliance and marketing communications 3. Monitoring and auditing 4. Enterprise risk management 5. Disciplinary programs and corrective action protocols Alignment Sustains Competitive Advantage in Compliant CultureAlignment Sustains Competitive Advantage in Compliant Culture
- 13. Myths/Misconceptions Affecting Collaboration Examples of Misaligned Beliefs Compliance thinks: Commercial thinks: On goals and objectives • They don’t understand the implications of non-compliant materials • They doesn’t understand that my sales forecast is going to be really difficult for me to achieve this year On being under pressure • I can be held personally responsible if we get in trouble, which can result in fines or even jail time • I’ll get a bad review and no promotion if I don’t make my numbers On adequate information • Some claims/promotional themes are simply not negotiable as they are emphatically violative • We are at a disadvantage when competitors promote in ways that we’re not allowed On communication • They think I can always give them an instant answer • They say no before they even listen to the idea On moving forward • We seem to have the same conversation over and over • They don't give me alternatives
- 14. Increase marketing budget X% by converting wasted agency fees to production of more promotional materials PRT Can Prove Its Value to Business With MetricsPRT Can Prove Its Value to Business With Metrics Increase # of promotional campaigns/materials approved by team X% without compromising review comprehensiveness
- 15. BrandBrand PlanningPlanning BrandBrand PlanningPlanning ConceptConcept ExecutionExecution ConceptConcept ExecutionExecution PRCPRCPRCPRC Filter out non-negotiable, noncompliant elements BEFORE submission RevisionsRevisionsRevisionsRevisions TacticalTactical ExecutionExecution TacticalTactical ExecutionExecution Rewrites minimized Faster output Reduce Number of Non-Compliant Materials From Entering SystemReduce Number of Non-Compliant Materials From Entering System
- 16. Effective Collaboration is CrucialEffective Collaboration is Crucial Needed to create enduring cultural change Key for strategic thinking, listening, coaching, cross functional knowledge, softer skills Critical to break down silos Address root cause for collaboration challenges The path forward requires a change in behaviors and attitude in order to successfully affect behaviors and cultures across functional boundaries to match the business objectives
- 17. Contact InformationContact Information Ilyssa Levins, President Center for Communication Compliance (CCC) ilevins@communicationcompliance.com p: 212-361-9868, f:212-980-3760 www.CommunicationCompliance.com www.Twitter.com/ILatCCC
Editor's Notes
- This presentation summarizes benchmark data demonstrating the quantitative impact of promotional review efficiency on driving a company’s top and bottom line. Specifically, PRT efficiency can turbo-charge commercial and compliance effectiveness.
- PRT efficiency can reduce waste, deliver new metrics and help stakeholders in multiple channels collaborate to improve productivity and professional satisfaction.
- PRT efficiency creates a healthy tension between the compliance functions and Commercial. Company leaders want to create an environment that protects and grows the business. To accomplish this, there needs to be alignment between Commercial and the compliance functions – regulatory, legal and compliance. Alignment creates a healthy tension where risk is reduced (compliance effectiveness) and sales are increased (commercial effectiveness). This serves the company, patients and improves overall health
- There are many external forces driving the need for PRT efficiency. This presentation puts a microscope on internal forces. These include rewrites of non-compliant materials submitted by promotional agencies and Marketing; the schism between commercial and compliance functions; and the fact that compliance is not considered “relevant” to the business. No company can control external market forces. But companies can address these internal forces that can make an organization vulnerable.
- Benchmark data show that rewriting non-compliant materials has a high cost: it hampers compliance and commercial effectiveness, which can quickly result in the loss of $2M annually (or more) for every ten brands a company markets. Moreover, when teams are not on the same baseline of regulatory knowledge, collaboration becomes challenging. A company’s investments in compliance oversight and promotional review rigor can easily drain away because of regulatory compliance knowledge and process gaps. This hidden vulnerability reduces profitability and hampers business growth.
- Data show that promotional regulatory professionals lose as much as 40 hours per month rewriting noncompliant promotional materials submitted by vendors without proven acumen in regulatory compliance fundamentals. This is more than 25% of a regulatory professional’s time. These data do not include time lost to rewrites experienced by a company’s legal, medical or marketing functions. In practical terms, that means a company with 15 people combined working in these functions – as is common for mid and large-size companies – those rewrites can result in more than $1 million dollars in waste annually.
- On top of that, calculations show that agency vendors executing promotional campaigns lose between $100,000 and $150,000 dollars per brand per year rewriting their own promotional materials deemed as noncompliant by the client. Most large brands work with multiple agencies such as advertising, public relations, and digital, so these figures can quickly add up to another $1MM dollars in wasted time annually. Again, keep in mind that these figures don’t factor in the regular fees billed by agencies for developing the original materials they thought were compliant.
- This waste is no surprise. The data show that marketing and agency professionals at every level (even senior executives) are incorrectly answering basic regulatory test questions. This clearly shows knowledge gaps on such fundamental issues as risk communication, reminder and disease state awareness ads, and consulting agreements with spokespeople, among other topics. In addition, when asked, marketing teams and their agencies often disagree with Regulatory on how to implement key initiatives within compliance, which leads to more waste. Disputed topics include digital initiatives, public relations tactics (media tours, releases), promotional education tactics (speaker’s bureaus, slide kits) and ad boards.
- Compounding the fact that regulatory knowledge gaps exist, the PRT is not always involved in very early discussions on proposed strategies and tactics proposed by marketing professionals and their agencies. As a result, the agency begins to develop campaigns – without any opportunity to filter out non-negotiable, non-compliance elements prior to submission to the promotional review team. The PRT must then redline the materials which are then rewritten by the agencies -- at a cost to the company. Ultimately, the review process is longer than necessary which means that marketing’s efforts are slowed down.
- Companies are also identifying internal vulnerabilities related to the promotional review process. Experts say that there are over one dozen review parameters that need to be considered when determining whether a promotional piece is compliant. What’s more, there are as many as 200 queries associated with these review parameters that could be considered during the review of a core campaign. Review comprehensiveness and efficiency can be derailed by individual levels of experience/expertise or reviews executed by new hires not yet trained in the company’s compliance policies. Additionally, when there are specific disagreements about a promotional piece, dispute resolution may not be efficient and resources can be spent on points of relative agreement while ignoring points of maximum disagreement. Companies traditionally conduct their in-person reviews by going line by line to discuss every comment. Reviewers also spent time looking for government documents to prove to Marketing that their assessment of the situation is in compliance with the law. Also, since Legal, Medical and Regulatory collaborate on the review process, there is often duplication and redundancy of comments which can waste time and money. It’s important that reviewers “swim in their functional lanes.” However, at the same time, companies don’t want to stifle collaboration which can lead to enhanced decision-making. If a company is under a CIA, these factors can potentially compromise compliance.
- In a survey fielded at a major industry conference attended by lawyers, regulatory professionals and compliance officers, participants were asked to rank five strategies in order of their impact on helping a company sustain a competitive advantage in a compliant culture. Alignment between regulatory professionals and their marketing communications colleagues were ranked as the most important next to leadership and commitment by senior management. The next slide will provide barriers to delivering on this strategy.
- Here are some myths held by Compliance and Commercial about one another that affect collaboration.
- When stakeholders are not on the same page, unnecessary rewrites increase in number and review cycles can take longer. Furthermore, when the disparate functions don’t appreciate on another’s expertise, there can be inter-departmental conflict and reduced morale. In some cases, this can reduce job satisfaction and increase turnover. As a result, companies experience a negative impact on Commercial and Compliance effectiveness. It is more costly to develop fewer selling materials with optimized claims, and the process is more i nefficient with increased risk and fewer optimized claims.
- The PRT can prove its value to the Business with metrics. Here are two examples of how the PRT can measure the impact of its efficiencies. These metrics are possible with new educational programs and testing systems that help promotional agencies and marketing teams to get on the same regulatory knowledge baseline. New web-based “screeners” now enable the commercial teams and agency partners pre-review materials before they are submitted for promotional review. There are also new training tools and algorithms to increase efficiency of the internal review process without compromising review comprehensiveness. Finally, new key performance indicators are available to measure the impact of these interventions.
- PRT can achieve these metrics in large part by reducing the number of non-compliant materials entering the system. The new PRT efficiency tools filter out non-negotiable, non-compliant elements before submission, which reduces rewrites leading to faster output of promotion.
- Effective collaboration between all stakeholders is crucial. Companies are wisely investing in infrastructure, technology platforms and processes that avoiding creating silos. And of course, leadership development is key for strategic thinking, listening, coaching, cross functional knowledge, and other softer skills that enhance collaboration. However, one barrier to collaboration still remains unaddressed: the human factor where emotions enter the business realm. In order to create enduring cultural change, we need to address the root cause for collaboration challenges and this is how we think about one another. Professionals in diverse functions who competently perform highly specialized and skilled jobs have distinct approaches to accomplishing their goals which can affect how they interact. Unproductive interactions have the potential to create an exponentially negative cascading effect on outcomes, including but not limited to reduced idea generation and tunnel vision. New tools are now available to help teams move from emotion-focused problem solving to solution-focused problem solving. The path forward requires a change in behaviors and attitude in order to successfully affect behaviors and cultures across functional boundaries to match the business objectives - Deloitte report
- So combine an efficient promotional review process with collaboration excellence and companies can create an integrity mindset. This mindset puts patients first, ensures mutual respect and engenders company pride. In terms of putting patients first, companies that experience fewer rewrites and shorter review cycles are more efficient without affecting review comprehensiveness. This results in more informative, fairly balanced materials in patients’ hands. In terms of mutual respect, when knowledge gaps are closed and everyone is on the same baseline of knowledge, diverse functions understand one another so there is less inter-departmental conflict and morale is enhanced. This results in improved team building, more job satisfaction and reduced turnover. In terms of pride, embracing a culture of compliance leads to fewer violations and less waste from rewrites. This money can be invested in innovation and education. Ultimately this enhances the company’s reputation. .