Quality campaigns that follow the rulesUnlikely combinations/making the most of the partnership
John give brief lesson on PR 101 – two way communication
Also…we are seeking innovative and creative approaches that will accelerate demand for……Enhancing the perceived value of our products clinically, financially andoperationallyto the media, physicians and patients.Build messages and communications platforms for advocacy allies.Devise innovative and compliant PR programs for the product that will enable maximum media pull-through at global, national and local levels
50 mph to 70 mph analogyYou don’t hire agencies not to push the envelope
Countries: International and national varianceCompanies: Different clients, different needsNew Global Guide to Pharma Marketing Codes with foreword from FDLI.
A chilly receptionShut down, freezes window of opportunityPanic sets in, but more often than not, there’s a way forward
Key is to understand the needs and goals of both the communications side, and the regulatory side.At the end of the day, we are both looking to improve human’s lives and wellbeing AND market, promote and sell.Conference is about advertising and promotion – neither of us want to be out of business.Prefer to think of it as a collaboration, building on shared principles; bridge differences to collaborate on end goals.
Balancing creativity with the rulesConvergenceEveryone has good intentions, yet it’s not often discussedBest practices need to come first
Thank you. This presentation is about an industry-wide problem – specifically the existence of regulatory knowledge gaps among promotional agencies and marketing professionals, which must be closed. This is the first time that the problem has been benchmarked. And while portions of these findings have been published individually, they have never been presented in a synthesized way until today.
These data have been culled from 3 surveys, certification test scores and dialogue with many of you in this room. The surveys were fielded in 2010 at 3 conferences by Rx Compliance Report, a subscription only industry publication. The attitudinal conferences include FDLI, CBI and DIA. All the surveys were statistically significant with a 95% confidence level. Data also include scores from CCC’s database of certification tests implemented over the past 4 years. Several thousand participants are in the database. These tests were developed by former FDA officials and regulatory lawyers under the supervision of Wayne Pines who is chair of the CCC Advisory Board. Finally, over a 12-month period, I had conversations with industry leadership to gauge reactions to the data. None were surprised by the findings and in fact, they felt that the data did not capture just how serious the problem really is.
Our first set of data presented today looks at agency knowledge gaps, in this case among PR agencies. 1/3 of participating PR staff failed a 12- question test after 3 attempts. Of the 68% who ultimately passed, it was only on the third attempt. And as you can see, on average they passed by the thinnest of margins at 81% -- the score required to pass was 80%. What makes these data so troublesome is that the participants were mid to senior level agency executives.
From a macro view, these are the types of questions that test takers from ad/promo, PR, PRM, digital, and promo med ed -- all marketing agencies -- typically get wrong. This one covers third-party spokespeople.
This one covers web sites.
This one addresses press releases.
Certification tests have also been administered to internal marketing departments. These question topics were culled from several pilot studies to diagnose internal knowledge gaps. Only a few participants passed this test which was specifically developed for marketing. As you can see, communication of risk is at the top of the list.
Another survey fielded by Rx Compliance Report queried participants on those tactics creating the greatest disagreement between regulatory, marketing and agencies. No surprise that digital communications ranked #1, following by PR tactics, promotional education tactics and Advisory Boards.
According to 76% of promotional regulatory professionals participating in this survey, it is estimate that on average, 21-40 hours are lost monthly to rewriting materials submitted by untrained agencies. If there are about 1800 working hours in a year, this represents over 25% of a regulatory professional’s time.
So let me conclude with 3 main take-aways. First, if you do the math, agency knowledge gaps cost our industry way too much in time lost by regulatory professionals due to promotional agency non-compliance. Based on earlier data presented, this equates to $200,000 in staff time yearly, which does not even include legal, medical, compliance or marketing’s time in the calculations provided in the presentation addendum.
The data also suggest that agencies could potentially be billing another $100,000/per brand/per year in staff time wasted on rewriting promotional materials kicked back by regulatory. Again, the calculations are in the presentation addendum.
Take-away #2: To address these alarming numbers, the educational strategy needs to keep in mind that the devil is in the details. Given that 77% of regulatory professionals are concerned that agency programs and materials could be sources of trouble in litigation, it becomes clear why an educational strategy must include the following elements:A focus on How To execute compliant tacticsThe need to drill down into the diverse disciplines -- Yes ad/promo is key but training and testing in PR, promotional education, patient relationship marketing, digital must also be executedIt’s critical to identify and address specific areas of misunderstandingAnd to confirm mastery of knowledge yearly
Take-away #3: We all know that regulatory is a high value partner to commercial. However, these data spotlight the opportunity for even greater marketing excellence.In essence, when marketing collaborates with regulatory to close knowledge gaps among their staff and agencies, you – the regulatory professional – drives greater marketing excellence ad thus, becomes their greatest allyTake a look why: what do you get with fewer rewrites, shorter review cycles, less drain on resources and healthier marketing budgets by reducing vendor costs. Marketing Efficiency.With fewer non starters and more time to optimize claims and review other products in the queue, sales materials get into the market quicker and fewer campaigns are pulled. This leads to Marketing Effectiveness. And by accelerating the transfer of balanced information, we have the ultimate market impact that is, by protecting and enhancing public health.
We can all agree that the ideal situation for our industry is to deliver higher quality promotional materials and reduce the wasted time and money associated with unproductive reviews. However, more quality and less waste is currently not the outcomes we see.That’s because regulatory, marketing and their promotional agencies are not aligned, but we can bridge the gap. I propose a 3-point plan to achieve this alignment: 1) change the current process 2) pinpoint dangerous regulatory compliance knowledge gaps to enhance decision-making3) and qualify all staff involved in the promotional process through regulatory compliance testing. Let me take you through the specifics.
Here’s another opportunity to improve the process:We need clear expectations as to what the authority and decision making is for every reviewer. This mitigates the impact of shopping for answers. The regulatory reviewer is the deep dive expert on the regulations and should be the first stop for regulatory answers. Legal should consider issues over and above the FDA regs such as Lanham Act, False Claims, etc. Medical should provide the review of the medical support for claimsHowever note that what may be medically appropriate in the practice of medicine will not always be considered substantial evidence by a regulatory reviewer. In other words, regulatory should avoid questioning the medical analysis but conclusions are fair game.
We have heard about the challenge and we have
1. Instilling Quality in Promotional Materials from Start to Finish: Effective Collaboration with Marketing and Media Companies Advertising and Promotion Conference October 2, 2012 Capitol Hilton Hotel | Washington, DC
2. Let‟s discuss…• How marketing, public relations and media partners/internal communications teams can effectively collaborate with regulatory departments to ensure: – FDA rules are met – Effective collaboration to create quality promotions
3. Today‟s Panel • Hamish Miller, Director of US Operations, Zinc Ahead, LTD • Ilyssa Levins, President and Founder, Center for Communication Compliance • Alan Bergstrom, Senior Director, Commercial Regulatory Affairs, Daiichi Sankyo, Inc. • Preeti I. Pinto, President, Preeti Pinto and Associates, LLC • Moderated by John J. Seng, President & CEO, Spectrum
4. John J. Seng President, SpectrumChair, GLOBALHealthPR
5. Communications 101
6. What the RFP says…
7. …is actively searching …creative means of for a highly creative, generating product strategic and results- demand andoriented public relations establishing market. agency…perform with nimbleness …developing a and agility… launch plan to maximize exposure and differentiation… Elevate the urgency of Ensure that new aggressive and early data on the product treatment of “condition” are communicated.
8. PR agencies willpush the limits
9. A complex regulatory patchwork
10. Regulatory pushes zero tolerance
11. Understanding Goals of Both Parties Communicat or Regulator Inspire action Guarantee safety Increase awareness Ensure fairnessEducate, empower the Safeguard compliance public At the end of the day…Improve health and wellbeing via commercialized products
12. Start off on the right foot
13. Takeaways from the PR firm perspective1. Align marketing, public relations, regulatory and corporate procurement from the start2. Clearly outline roles and responsibilities on the customer side3. Ensure that requests for work are compliant4. Define and encourage 360 training as appropriate
14. Thank you.John J. Seng | firstname.lastname@example.org Founder and President, Spectrum Founder and Chair, GLOBALHealthPR www.spectrumscience.com |www.globalhealthpr.com @JohnJSeng | @Spectrumscience
15. Hamish MillerDirector of US Operations, Zinc Inc.
16. Agenda• Share a number of key trends and pose a number of questions – Review times – Cancellations – Review rounds – SOP‟s
17. “Quality means doing it right when no one is looking”
18. Scope of Data• Over the last 11 years we‟ve observed varying degrees of quality within the promotional review processes in over 165 Countries
19. Scope of Data• We have seen in excess of 500,000 pieces of material start the promotional review process globally
20. Common Objectives / Challenges• Compliance• Transparency / accountability• Collaboration, approval and sharing of material• Version control, expiration & re-approval of material
21. Unique Objectives / Challenges• There are big differences by region
22. Unique Objectives / Challenges• There are big differences by region• BUT we also see big differences within regions…
23. Average Review Times (Days) - Industry Average review times in the US are in the region of 25 days
24. Average Review Times (Days) Some companies can take 40 + days; while others take as little as 7 days
25. % cancelled during review - Industry Around 15% of material sent out for review is subsequently cancelled
26. % cancelled during review We also see some companies cancelling over 35% and some companies cancelling as little a 7%
27. Average # of review rounds - Industry The average number of review rounds is two
28. Average # of review rounds With some companies taking over three…..
29. Summary• Why do we see such big differences in US?• Why do some companies take twice the industry average to review material?• Why is 15% of material consistently cancelled?• Why do some companies take 3.5 rounds of review to get material approved?• Why do 40% of companies not have clear SOP‟s in place?
30. Thank you Participate and Receive Benchmarking Data:HamishMiller@Zinc-Ahead.com
31. Closing Knowledge Gaps Ilyssa Levins, PresidentCenter for Communication Compliance (CCC)
32. Benchmark DataConference Surveys Rx Compliance Report FDLI - October 2010 CBI - June 2010 DIA – May 2010Test Scores Center for Communication Compliance (CCC) Mined from certification test score databaseConversations Senior industry leadership: pharma companies and agencies
33. Knowledge Gaps: Agencies• One-third of participating PR agency staff (32%) failed 12-question test after 3 attempts Passed on third attempt: 68% Average score: 81% (80% score required to pass) Test takers were mid to senior level executives (2008 baseline)33
34. Knowledge Gaps: Types of Questions Marketing Agencies Get WrongQ: Indicate which two statements reflect the PhRMA Code in regard to third-party spokespeople: A. Third-party spokespeople may not be paid to speak with the media B. Third-party spokespeople must have published in peer-reviewed journals on the subject area on which they are speaking for the company C. The total number of spokespeople in a speakers bureau must correlate with what is needed to achieve the firm‟s business purpose (correct) D. The spokesperson services contracted for must meet a legitimate and documented need, and payment should represent the fair market value for services provided (correct) E. Every consultant who speaks for a company in support of a prescription drug must have an MD, a PhD, or a PharmD degree *Ad/promo, PR, PRM, Digit al, Promo med ed –
35. Knowledge Gaps: Types of Questions Marketing Agencies Get WrongQ. Which of the following features of a companys product Web site does theFDA regard as potentially being subject to its enforcement authority? A. Statements or conclusions about product safety and/or efficacy for drugs still under investigation B. Lack of fair balance in promotional information about approved products C. Links to other sites that contain promotional information about uses that are off-label for a product D. For drugs that have already been approved outside of the U.S., information about the product that might be allowable in those countries but is misleading on a Web site accessible by U.S. residents E. All of the above (correct answer)• *Ad/promo, PR, PRM, Digital, Promo med ed
36. Knowledge Gaps: Types of Questions Marketing Agencies Get WrongQ: A promotional press release issued at the time that a new product is beinglaunched must: A. Be cleared by DDMAC before issuance B. Be shared with the FDA Press Office before issuance C. Discuss all the major research being conducted on the product D. Contain a "fair balance" of the benefits of the product and its risks (correct answer) E. All of the above F. None of the above36 *Ad/promo, PR, PRM, Digit al, Promo med ed
37. Knowledge Gaps: Types of QuestionsInternal Marketing Departments Get Wrong Summary of question „topics‟ missed: • Risk communication • Pre-submission requirements • Reminder and disease state awareness ads • Use of spokespeople 37
38. Schism• Greatest disconnects between regulatory, marketing and agencies occur with: 1. Digital communications 2. Public Relations • Media tours • Press releases 3. Promotional Education • Speaker‟s bureaus • Slide kits 4. Advisory Boards38
39. Hours Lost to Rewrites• 76% of promotional regulatory professionals say: 21 - 40 hours lost monthly rewriting promotional materials submitted by untrained agencies• With 1800 working hours/year, > 25% of regulatory‟s time39
40. Take-away #1: Agency Knowledge Gaps Cost Too Much• Time Lost By Regulatory Professionals – $200,000 in staff time yearly • Does not include legal, medical, compliance, marketing40
41. Take-away #1: Agency Knowledge Gaps Cost Too Much (continued)• Time Wasted by Agency Staffers – $100,000/year/brand in agency billings41
42. Take-away #2: Devil is in Details77% of regulatory professionals are concerned that agency programs and materials could be sources of trouble in litigationEducational strategy Focus on how to execute compliant tactics Drill down into the diverse disciplines Yes to ad/promo, but also: – PR, promotional education, patient relationship marketing, digital Identify and address specific areas of misunderstanding Confirm mastery of knowledge yearly
43. Take-away # 3: Regulatory is High Value Partner to CommercialClose knowledge gaps = greater marketing excellence = ally Marketing Marketing Marketing Efficiency Effectiveness Impact Fewer rewrites Fewer non-starters; Accelerated (more useable big ideas) transfer of balanced Shorter review health information cycles More time to optimize claims Protects and Less drain on enhances public resources More time to review other health products in queue Healthier marketing budgets Sales materials in market by reducing vendor quicker costs Fewer campaigns pulled
44. Closing Knowledge Gaps Ilyssa Levins, PresidentCenter for Communication Compliance (CCC) ilevins@CommunicationCompliance.com 212-361-9868
45. Addendum: Calculations• Time Lost By Regulatory Professionals due to noncompliant agencies – $200,000 in staff time yearly • Assumptions -Average 12 review cycles/processes/year for one brand -Average cost of regulatory professional = $150/hr -Regulatory reviews work submitted by three agencies • Calculations –$150/hr. X 21-40 hours = $3,150-$6,000/month –$3,150-$6,000/month X 12 review cycles = $37,800-$72,000 –$37,800-$72,000 X 3 agencies = $113,400-$216,000• Time Wasted By Agencies due to noncompliance – $100,000/year/brand in agency billings • Assumptions –Average cost of agency professional = $100/hr. –Minimally, three staff assigned to brand = $300/hour • Calculations –$300/hour X 21-40 hours = $6,300-$12,000 per review cycle45 –$6,300-$12,000 X 12 review cycles = $75,600-$144,000
46. Instilling Quality in Promotional Materials from Start to Finish: Effective Collaboration with Marketing and Media Companies Advertising and Promotion Conference October 2, 2012 Capitol Hilton Hotel | Washington, DC
47. Improving Quality and Reducing Waste ThroughAgency/Company Partnership Alan Bergstrom, Senior Director Commercial Regulatory Affairs Daiichi Sankyo, Inc.
48. Disclaimer The content, views, and opinions in this presentation are my own and do not inanyway represent the views or opinions of Daiichi Sankyo, Inc.
49. More Quality, Less Waste Marketing/AgencyRegulatory Pinpoint Qualify Change Process + Knowledge Gaps + Staff
50. The Current ProcessRegulatory typically not involved in Core Brand Team Brand Concept PRC Revisions Tactical Planning Execution Execution Concept reviews traditionally take place here
51. Broken Internal System Marketing presents ideas to senior management who Substantial time, effort and questions tactics, BUT … money spent by the agency Brand Concept PRC Revisions Tactical Planning Execution Execution Regulatory was not involved earlier to discuss proposedstrategies/tactics … or vet post marketing medical affairs studies to be sure they support claims
52. Agencies Fuel the Waste Agencies hatch big ideas with few regulatory compliance Marketing drains Lengthy review process parameters PRC resources with slows down marketing unnecessary reviews execution Non-starter’ ideas get explored and expandedBrand Concept PRC Revisions TacticalPlanning Execution Execution Agency develops noncompliant campaigns embraced by Agency rewrites materials at marketing as differentiating cost to the company
53. Opportunity: Improving the Process Substantial evidence = regulatory decision NOT marketing or medical affairs Need data dump at study conclusion for all PRC reviewers BEFORE promotional tactics are developed and presented to PRCBrand Concept PRC Revisions TacticalPlanning Execution Execution Regulatory reviewer has already determined that data is substantial and doesn’t overstate safety or efficacy
54. Opportunity: Improve the Process • Clear expectations for review authority, decision making stops „shopping for answers‟Regulatory is deep dive expert on regs Medically appropriate in practice of First stop for related answers medicine not always considered substantial evidence by regulatoryLegal focuses on issues over/above FDA regs Lanham Act, False Claims, etc. Regulatory should avoid questioning medical/legal analysis … butMedical focused on review of medical support conclusions fair gamefor claims
55. Opportunity: Close Knowledge Gaps Qualify Train to teach Marketing Test to confirm fundamentals and fundamentals Agency Partners Education for Everyone Gets Everyone on Same Baseline Marketing, Managed Care, Sales, Agencies … And Regulatory
56. Preeti PintoPreeti Pinto and Associates, LLC
57. SoTo reduce waste and increase value, we: Have educated ad agencies/commercial staff Have clarified roles and responsibilities Are included in the concept phase Now let us change marketing behavior
58. Best PracticesTake joint accountability for Optimizing claims Regulatory compliance Efficient processesCommunicate clearly Comments understood? Comments actionable? Comments recommend an alternate solution that addresses business needs?Develop regulatory guidances/processes
59. Guidance Development New Platform or TacticGuidance and Regulatory and Legal Process Identification of ConsiderationsDevelopment regulatory hurdles before signing contract Consistent Application to All Marketing Prototype Considerations Development TAs and Brands Regulatory Considerations
60. Best PracticesCreativeDevelopment Market Concept Research Joint Accountability Pre-Concept Copy Review Clear Communication Regulatory Guidance Development Clinical Trial Design Promotional Piece Target Profile
61. Gave examples of few best practices More best practices can be implemented Win win for all Team meetings could be spent optimizing claims and promotional value of the piece instead of “lack of substantial evidence” and “where is the fair balance.”