Closing Knowledge Gaps       Ilyssa Levins, PresidentCenter for Communication Compliance                (CCC)
Benchmark DataConference Surveys       Rx Compliance Report              FDLI - October 2010              CBI - June 2010 ...
Knowledge Gaps: Agencies• One-third of participating PR agency staff (32%) failed  12-question test after 3 attempts      ...
Knowledge Gaps: Types of Questions     Marketing Agencies Get WrongQ: Indicate which two statements reflect the PhRMA Code...
Knowledge Gaps: Types of Questions      Marketing Agencies Get WrongQ. Which of the following features of a companys produ...
Knowledge Gaps: Types of Questions      Marketing Agencies Get WrongQ: A promotional press release issued at the time that...
Knowledge Gaps: Types of QuestionsInternal Marketing Departments Get Wrong Summary of question ‘topics’ missed: •Risk comm...
Schism• Greatest disconnects between regulatory, marketing and  agencies occur with:    1. Digital communications    2. Pu...
Hours Lost to Rewrites• 76% of promotional regulatory professionals say:      21 - 40 hours lost monthly rewriting        ...
Take-away #1:     Agency Knowledge Gaps Cost Too Much• Time Lost By Regulatory Professionals   – $200,000 in staff time ye...
Take-away #1: Agency Knowledge Gaps       Cost Too Much (continued)• Time Wasted by Agency Staffers   – $100,000/year/bran...
Take-away #2: Devil is in Details77% of regulatory professionals are concerned that agency programs       and materials co...
Take-away # 3: Regulatory is High      Value Partner to CommercialClose knowledge gaps = greater marketing excellence = al...
Closing Knowledge Gaps           Ilyssa Levins, PresidentCenter for Communication Compliance (CCC)  ilevins@CommunicationC...
Addendum: Calculations•    Time Lost By Regulatory Professionals due to noncompliant agencies      – $200,000 in staff tim...
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Closing Marketing and Agency Knowledge Gaps in Regulatory Compliance For Healthcare (w/o notes)

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

Published in: Health & Medicine
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Closing Marketing and Agency Knowledge Gaps in Regulatory Compliance For Healthcare (w/o notes)

  1. 1. Closing Knowledge Gaps Ilyssa Levins, PresidentCenter for Communication Compliance (CCC)
  2. 2. 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
  3. 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)3
  4. 4. 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, Digital, Promo med ed
  5. 5. 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
  6. 6. 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 above6 *Ad/promo, PR, PRM, Digital, Promo med ed
  7. 7. 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 7
  8. 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 Boards8
  9. 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 time9
  10. 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, marketing10
  11. 11. Take-away #1: Agency Knowledge Gaps Cost Too Much (continued)• Time Wasted by Agency Staffers – $100,000/year/brand in agency billings11
  12. 12. 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 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. 13. 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 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. 14. Closing Knowledge Gaps Ilyssa Levins, PresidentCenter for Communication Compliance (CCC) ilevins@CommunicationCompliance.com 212-361-9868
  15. 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 cycle15 –$6,300-$12,000 X 12 review cycles = $75,600-$144,000
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