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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
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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
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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
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John J. Seng
President, Spectrum
Chair, GLOBALHealthPR
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Communications 101
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What the RFP says…
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…creative means of
generating product
demand and
establishing market.
…developing a launch
plan to maximize
exposure and
differentiation…
Ensure that new data
on the product are
communicated.
…is actively searching for a
highly creative, strategic and
results-oriented public
relations agency…
perform with nimbleness and
agility…Elevate the urgency of
aggressive and early
treatment of “condition”
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PR agencies will
push the limits
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A complex regulatory
patchwork
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Regulatory pushes zero tolerance
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Understanding Goals of Both Parties
Communicator
Inspire actionIncrease awareness
Educate, empower the public
Regulator
Guarantee safetyEnsure fairnessSafeguard compliance
At the end of the day…
Improve health and wellbeing via commercialized
products
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Start off on the right foot
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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
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Thank you.John J. Seng | [email protected]
Founder and President, Spectrum Founder and Chair, GLOBALHealthPR
www.spectrumscience.com |www.globalhealthpr.com
@JohnJSeng | @Spectrumscience
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Hamish Miller
Director of US Operations, Zinc Inc.
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Agenda
• Share a number of key trends and pose a number of questions– Review times– Cancellations– Review rounds– SOP’s
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“Quality means doing it right when no one is looking”
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Scope of Data
• Over the last 11 years we’ve observed varying degrees of quality within the promotional review processes in over 165 Countries
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Scope of Data
• We have seen in excess of 500,000 pieces of material start the promotional review process globally
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Common Objectives / Challenges
• Compliance• Transparency / accountability• Collaboration, approval and sharing of
material• Version control, expiration & re-approval of
material
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Unique Objectives / Challenges
• There are big differences by region
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Unique Objectives / Challenges
• There are big differences by region• BUT we also see big differences within regions…
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Average Review Times (Days)- Industry
Average review times in the US are in the region of 25 days
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Average Review Times (Days)
Some companies can take 40 + days; while others take as little as 7 days
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% cancelled during review- Industry
Around 15% of material sent out for review is subsequently cancelled
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% cancelled during review
We also see some companies cancelling over 35% and some companies
cancelling as little a 7%
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Average # of review rounds- Industry
The average number of review rounds is two
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Average # of review rounds
With some companies taking over three…..
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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?
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Closing Knowledge Gaps
Ilyssa Levins, President
Center for Communication Compliance (CCC)
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Benchmark Data
Conference SurveysRx Compliance Report
FDLI - October 2010
CBI - June 2010
DIA – May 2010
Test Scores
Center for Communication Compliance (CCC)
Mined from certification test score databaseConversations
Senior industry leadership: pharma companies and agencies
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Knowledge Gaps: Agencies
• One-third of participating PR agency staff (32%) failed 12-question test after 3 attempts
33
Passed on third attempt: 68%
Average score: 81% (80% score required to pass)
Test takers were mid to senior level executives (2008 baseline)
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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, Digital, Promo
med ed
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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
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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, Digital,
Promo med ed
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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
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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
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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
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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
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Take-away #1: Agency Knowledge Gaps Cost Too Much (continued)
• Time Wasted by Agency Staffers – $100,000/year/brand in agency billings
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Take-away #2: Devil is in Details
Drill down into the diverse disciplines
Yes to ad/promo, but also:
– PR, promotional education, patient relationship marketing, digital
Educational strategy
Focus on how to execute compliant tactics
Confirm mastery of knowledge yearly
Identify and address specific areas of misunderstanding
77% of regulatory professionals are concerned that agency programs and materials could be sources of trouble in litigation
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Marketing
Efficiency
Marketing
Effectiveness
Fewer non-starters;
(more useable big ideas)
More time to optimize claims
More time to review other
products in queue
Sales materials in market
quicker
Fewer campaigns pulled
Accelerated
transfer of balanced
health information
Protects and enhances
public health
Fewer rewrites
Shorter review cycles
Less drain on
resources
Healthier marketing
budgets by reducing
vendor costs
Take-away # 3: Regulatory is High Value Partner to Commercial
Close knowledge gaps = greater marketing excellence = ally
Marketing
Impact
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Closing Knowledge Gaps
Ilyssa Levins, President
Center for Communication Compliance (CCC)
212-361-9868
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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–$6,300-$12,000 X 12 review cycles = $75,600-$144,000
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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
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Improving Quality and Reducing Waste Through
Agency/Company Partnership
Alan Bergstrom, Senior Director
Commercial Regulatory Affairs
Daiichi Sankyo, Inc.
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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.
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More Quality, Less WasteR
egu
lato
ry
Mar
keti
ng
/Ag
ency
Change
Process
Pinpoint
Knowledge
Gaps+
Qualify
Staff+
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The Current Process
Brand
Planning
Brand
Planning
Concept
Execution
Concept
Execution
PRCPRC
Concept reviews traditionally
take place here
Regulatory typically not involved in Core Brand Team
RevisionsRevisions Tactical
Execution
Tactical
Execution
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Broken Internal System
Brand
Planning
Brand
Planning
Concept
Execution
Concept
Execution
PRCPRC
Regulatory was not involved earlier to discuss proposed strategies/tactics … or
vet post marketing medical affairs studies to be sure they support claims
Substantial time, effort and
money spent by the agency
RevisionsRevisions Tactical
Execution
Tactical
Execution
Marketing presents ideas
to senior management who
questions tactics, BUT …
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Agencies Fuel the Waste
Brand
Planning
Brand
Planning
Concept
Execution
Concept
Execution
PRCPRC
Agencies hatch big ideas with few
regulatory compliance parameters
Non-starter’ ideas get explored and
expanded
RevisionsRevisions Tactical
Execution
Tactical
Execution
Agency develops noncompliant
campaigns embraced by marketing as
differentiating
Marketing drains
PRC resources with
unnecessary reviews
Agency rewrites materials at cost to
the company
Lengthy review process slows
down marketing execution
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Opportunity: Improving the Process
Brand
Planning
Brand
Planning
Concept
Execution
Concept
Execution
PRCPRC
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
RevisionsRevisions Tactical
Execution
Tactical
Execution
Regulatory reviewer has already determined that data is
substantial and doesn’t overstate safety or efficacy
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Opportunity: Improve the Process
• Clear expectations for review authority, decision making stops ‘shopping for answers’
Regulatory is deep dive expert on regs
First stop for related answers
Legal focuses on issues over/above FDA regs
Lanham Act, False Claims, etc.
Medical focused on review of medical support
for claims
Medically appropriate in practice of medicine
not always considered substantial
evidence by regulatory
Regulatory should avoid questioning
medical/legal analysis … but
conclusions fair game
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Education for Everyone Gets
Everyone on Same Baseline
Marketing, Managed Care, Sales, Agencies … And Regulatory
Train to teach
fundamentals
Test to confirm
fundamentals
Opportunity: Close Knowledge Gaps
Qualify
Marketing
and Agency
Partners
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Preeti Pinto
Preeti Pinto and Associates, LLC
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So
To reduce waste and increase value, we:
Have educated ad agencies/commercial staff
Are included in the concept phase
Now let us change marketing behavior
Have clarified roles and responsibilities
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Best PracticesTake 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
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Guidance Development
Prototype Development
Regulatory
Considerations
New Platform or
Tactic
Regulatory and Legal
Considerations
Guidance and Process
Development
Marketing Considerations
Identification of regulatory hurdles
before signing contract
Consistent Application to All TAs
and Brands
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Best Practices
Clinical Trial Design
Promotional
Piece
Copy Review
Concept
Pre-Concept
Creative Development
Market Research
Regulatory Guidance Development
Clear Communication
Joint Accountability
Target Profile
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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.”