New data spotlight value of Train + Test approach to close dangerous regulatory knowledge gaps. Expert presents 3-point plan to enhance compliance education (Slide 49 and 55)

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, Spectrum
Chair, 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 and
oriented 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 will
push 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 fairness
Educate, 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 perspective
1. Align marketing, public relations,
regulatory and corporate procurement
from the start
2. Clearly outline roles and responsibilities
on the customer side
3. Ensure that requests for work are
compliant
4. Define and encourage 360 training as
appropriate

14. Thank you.
John J. Seng | jjs@spectrumscience.com
Founder and President, Spectrum
Founder and Chair, GLOBALHealthPR
www.spectrumscience.com
|www.globalhealthpr.com
@JohnJSeng | @Spectrumscience

15. Hamish Miller
Director 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, President
Center for Communication Compliance
(CCC)

32. Benchmark Data
Conference Surveys
Rx Compliance Report
FDLI - October 2010
CBI - June 2010
DIA – May 2010
Test Scores
Center for Communication Compliance (CCC)
Mined from certification test score database
Conversations
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 Wrong
Q: 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 speaker's 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 Wrong
Q. Which of the following features of a company's product Web site does the
FDA 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 Wrong
Q: A promotional press release issued at the time that a new product is being
launched 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 above
36 *Ad/promo, PR, PRM, Digit
al, Promo med ed

37. Knowledge Gaps: Types of Questions
Internal 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 Boards
38

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 time
39

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, marketing
40

41. Take-away #1: Agency Knowledge Gaps
Cost Too Much (continued)
• Time Wasted by Agency Staffers
– $100,000/year/brand in agency billings
41

42. Take-away #2: Devil is in Details
77% of regulatory professionals are concerned that agency programs
and materials could be sources of trouble in litigation
Educational 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 Commercial
Close 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, President
Center 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 cycle
45
–$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 Through
Agency/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 in
anyway represent the views or opinions of
Daiichi Sankyo, Inc.

49. More Quality, Less Waste
Marketing/Agency
Regulatory
Pinpoint Qualify
Change
Process + Knowledge
Gaps
+ Staff

50. The Current Process
Regulatory 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 proposed
strategies/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 expanded
Brand Concept PRC Revisions Tactical
Planning 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 PRC
Brand Concept PRC Revisions Tactical
Planning 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 regulatory
Legal focuses on issues over/above FDA regs
Lanham Act, False Claims, etc. Regulatory should avoid questioning
medical/legal analysis … but
Medical focused on review of medical support conclusions fair game
for 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 Pinto
Preeti Pinto and Associates, LLC

57. So
To 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

59. Best Practices
Take joint accountability for
Optimizing claims
Regulatory compliance
Efficient processes
Communicate clearly
Comments understood?
Comments actionable?
Comments recommend an alternate solution that addresses
business needs?
Develop regulatory guidances/processes

60. Guidance Development
New Platform or
Tactic
Guidance and Regulatory and Legal
Process Identification of Considerations
Development regulatory hurdles
before signing
contract
Consistent
Application to All Marketing
Prototype Considerations
Development
TAs and Brands
Regulatory
Considerations

61. Best Practices
Creative
Development Market
Concept Research
Joint Accountability
Pre-Concept Copy Review
Clear Communication
Regulatory Guidance
Development
Clinical Trial Design
Promotional
Piece
Target Profile

62. 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.”