Presentation given by Ilyssa Levins to the Food and Drug Law Institute's Advertising & Promotion Conference on 10/2/2012.

1. Closing Knowledge Gaps
Ilyssa Levins, President
Center for Communication Compliance
(CCC)

2. 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

3. 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)
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4. 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

5. 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

6. 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
6 *Ad/promo, PR, PRM, Digital,
Promo med ed

7. 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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8. 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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9. 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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10. 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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11. 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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12. 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
Drill down into the diverse disciplines
Focus on how to execute compliant tactics
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

13. 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 cycles health information
More time to optimize claims
Less drain on Protects and enhances
resources More time to review other public health
products in queue
Healthier marketing

14. Closing Knowledge Gaps
Ilyssa Levins, President
Center for Communication Compliance (CCC)
ilevins@CommunicationCompliance.com
212-361-9868

15. 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
15 –$6,300-$12,000 X 12 review cycles = $75,600-$144,000