Closing Marketing and Agency Knowledge Gaps in Regulatory Compliance For Healthcare (with 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.
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Closing Marketing and Agency Knowledge Gaps in Regulatory Compliance For Healthcare (with notes)
- 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) 3
- 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 7
- 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 8
- 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 9
- 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 10
- 11. Take-away #1: Agency Knowledge Gaps Cost Too Much (continued) • Time Wasted by Agency Staffers – $100,000/year/brand in agency billings 11
- 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
Editor's Notes
- 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 tactics The 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 executed It’s critical to identify and address specific areas of misunderstanding And 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 ally Take 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.