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Maureen Shaffer<br />Vice President, Life Sciences, Prolifiq<br />www.prolifiq.net/lifesciences<br />Executive Editor & Pu...
Deleterious Duo:  Off-Label Sales Communications and Product Liability<br />As FDA, DOJ and the SEC increase their investi...
Disclosures<br />Good Promotional Practices is sponsored by Prolifiq and Reprints Desk<br />Prolifiq is an AdvaMed Busines...
Sales: Off-Label HCP Promotion<br />Image courtesy of Navigant: Life Science Product Value Preservation in a Changing Sea ...
Agenda<br />Off-Label Sales Promotion<br />It’s All About the Numbers<br />Standard Seven Compliance Recommends<br />Good ...
Off-label sales promotionall about the numbers<br />
70% Whistleblowers are Sales<br />
92% DOJ Convictions are Small Cos<br /><ul><li>In pharma, “we are seeing people driving 67 in the middle lane as opposed t...
“You still see a fair amount of wild west behavior in some of these smaller companies, particularly in the biotech and med...
400x More Individuals; 50% Mgmt<br />Jailing Individuals: What’s Next in Fraud and FCPA<br />
40% Drop in Stock Price Overnight<br />DOJ probe<br />$3.8M & CIA<br />AtriCure stock plunges amid marketing probe. Wall S...
Standard seven compliance recommendsgood starting Point; rethink for sales environment<br />
Standard Seven OIG Recommends<br />Standards and Procedures<br />Oversight<br />Education and Training<br />Auditing and M...
Sales is Mobile, Verbal, Efficient=$<br />
Compliance: Yielding w/o Disruption<br />
Seven insights to preventing off-label sales promotion<br />
Hire Integrity and Team Players<br />Hiring is everyone’s job--Google<br />Cross-functional team interviews<br />Respectfu...
Listen and Respond<br />Only 3% call the hotline<br />Symantec, low #s for Google and MDT<br />But, 75% take the problem t...
Off-Label Education: Who<br />Tone at the middle (Intel and AIG)<br />Interwoven throughout organization<br />Video from C...
Off-Label Education: Back to Basics<br />Are your oral and written statements:<br />Truthful and non-misleading<br />Fair ...
Off-Label Education: How<br />Verbal: Role-playing before and after<br />New launches<br />Major scientific meetings<br />...
When: Ongoing & Sustainable<br />6<br />
Make On-Message Easier than Off<br />7<br />Latest and greatest materials?<br />Easy to submit request for article?<br />O...
Excellent Resources<br />Your own sales force or distributors<br />http://wp.me/p12znw-yH<br />Good Promotional Practices<...
Contact Information<br />Maureen Shaffer Vice President, Life Sciences, Prolifiq<br />maureen.shaffer@prolifiq.net<br />ww...
Real-Life Ideas for Sales Managers<br />Educate<br />Your reps need to know what uses are approved/cleared and what is off...
The Habitual Mind<br />When something is a habit, the PFC signals the STN at a very low rate<br />Conserves cognitive reso...
Top Off-Label Complaints<br />
Get a Cross-Functional PRC<br />
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Preventing Off-label Sales Promotion

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Deleterious Duo: Off-Label Sales Communications and Product Liability

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Preventing Off-label Sales Promotion

  1. 1. Maureen Shaffer<br />Vice President, Life Sciences, Prolifiq<br />www.prolifiq.net/lifesciences<br />Executive Editor & Publisher, Good Promotional Practices www.goodpromotionalpractices.com<br />Preventing Off-Label Sales Promotion<br />First presented at AdvaMed EGCC on 05/03/2011<br />
  2. 2. Deleterious Duo:  Off-Label Sales Communications and Product Liability<br />As FDA, DOJ and the SEC increase their investigative and enforcement activities, off-label sales communications and activities have resulted in individual criminal prosecutions and have provided a bottoms-up entree into the company records. These illegal activities can create litigation momentum and have a negative impact on your company's defensibility during product liability litigation. To protect both your company and your growing sales force from expensive, distracting and resource-depleting government actions, join us for an enlightening discussion on how to mitigate both front-end off-label activities and back-end product liability exposure.<br />
  3. 3. Disclosures<br />Good Promotional Practices is sponsored by Prolifiq and Reprints Desk<br />Prolifiq is an AdvaMed Business Solutions Partner<br />
  4. 4. Sales: Off-Label HCP Promotion<br />Image courtesy of Navigant: Life Science Product Value Preservation in a Changing Sea of Liability Risk; kcornish@navigant.com<br />
  5. 5. Agenda<br />Off-Label Sales Promotion<br />It’s All About the Numbers<br />Standard Seven Compliance Recommends<br />Good Starting Point<br />Rethink for Sales Environment<br />Seven Insights to Preventing Off-Label Sales Promotion<br />
  6. 6. Off-label sales promotionall about the numbers<br />
  7. 7. 70% Whistleblowers are Sales<br />
  8. 8. 92% DOJ Convictions are Small Cos<br /><ul><li>In pharma, “we are seeing people driving 67 in the middle lane as opposed to 92 in the fast lane.” “That makes our job harder.”
  9. 9. “You still see a fair amount of wild west behavior in some of these smaller companies, particularly in the biotech and medical device sectors, where you are not necessarily going to have a whole compliance team set up that is deeply immersed in these issues.” </li></ul>Rx Compliance Report, “Federal prosecutors report slowdown in the filing of new fraud claims, say less egregious violations cited”, Vol. IX, Issue 9/July 21, 2010. <br />
  10. 10. 400x More Individuals; 50% Mgmt<br />Jailing Individuals: What’s Next in Fraud and FCPA<br />
  11. 11. 40% Drop in Stock Price Overnight<br />DOJ probe<br />$3.8M & CIA<br />AtriCure stock plunges amid marketing probe. Wall Street Journal, 11/04/2008. <br />
  12. 12. Standard seven compliance recommendsgood starting Point; rethink for sales environment<br />
  13. 13. Standard Seven OIG Recommends<br />Standards and Procedures<br />Oversight<br />Education and Training<br />Auditing and Monitoring<br />Reporting<br />Enforcement and Discipline<br />Response and Prevention<br />www.ussc.gov<br />www.oig.hhs.gov<br />
  14. 14. Sales is Mobile, Verbal, Efficient=$<br />
  15. 15. Compliance: Yielding w/o Disruption<br />
  16. 16. Seven insights to preventing off-label sales promotion<br />
  17. 17. Hire Integrity and Team Players<br />Hiring is everyone’s job--Google<br />Cross-functional team interviews<br />Respectful of their colleagues’ environments?<br />No sales prevention or regulatory roadblocks<br />Past cross-functional interactions and references?<br />Independent*, clean background and social media checks?<br />1<br />*9 Notable Insights from AMEX<br />
  18. 18. Listen and Respond<br />Only 3% call the hotline<br />Symantec, low #s for Google and MDT<br />But, 75% take the problem to their manager<br />Symantec<br />“50% of fraud whistleblower cases could have been prevented if someone had listened, responded and investigated proactively”<br />Whistleblower Action Network<br />2<br />Dow-Jones Global Compliance Symposium<br />
  19. 19. Off-Label Education: Who<br />Tone at the middle (Intel and AIG)<br />Interwoven throughout organization<br />Video from CEO doesn’t do it<br />Sales managers train their managers who train their managers<br />Living the story<br />Repetition creates memory and belief<br />3<br />
  20. 20. Off-Label Education: Back to Basics<br />Are your oral and written statements:<br />Truthful and non-misleading<br />Fair balance between benefit and risk<br />Communication of material facts<br />If we can only retain seven things at a time, what 7 things do you want your reps to remember about off-label every day?<br />4<br />
  21. 21. Off-Label Education: How<br />Verbal: Role-playing before and after<br />New launches<br />Major scientific meetings<br />New scientific studies<br />Mandate in ride-alongs and document<br />Mobile is Efficient=$: Incorporate learning with quick, regular communications<br />Work with corpcomm or marketing, e.g. weekly texts<br />Reading paper does not equal compliance<br />5<br />Keeping Companies Out of Trouble: Notes from Google’s and UPS’ Compliance Programs<br />
  22. 22. When: Ongoing & Sustainable<br />6<br />
  23. 23. Make On-Message Easier than Off<br />7<br />Latest and greatest materials?<br />Easy to submit request for article?<br />Off-label scientific requests?<br />Real-time compliance questions<br />Keeping Companies Out of Trouble<br />Poll data courtesy of Prolifiq<br />
  24. 24. Excellent Resources<br />Your own sales force or distributors<br />http://wp.me/p12znw-yH<br />Good Promotional Practices<br />www.GoodPromotionalPractices.com<br />AdvaMed MTLI courses<br />www.advamedmtli.org<br />RAPS.org<br />www.raps.org<br />Dow Jones Global Compliance Symposium<br />www.gcs.dowjones.com<br />
  25. 25. Contact Information<br />Maureen Shaffer Vice President, Life Sciences, Prolifiq<br />maureen.shaffer@prolifiq.net<br />www.prolifiq.net/lifesciences<br />415-341-6863 mobile<br />Executive Editor & Publisher, Good Promotional Practices<br />maureen.shaffer@goodpromotionalpractices.com<br />www.goodpromotionalpractices.com<br />www.linkedin.com/in/maureenashaffer<br />www.twitter.com/maureenshaffer<br />
  26. 26. Real-Life Ideas for Sales Managers<br />Educate<br />Your reps need to know what uses are approved/cleared and what is off-label. <br />Before your quarterly sales meetings, review current best practices and emerging uses occurring in the field<br />Surgeons will often come back from a society meeting having talked to their colleagues about new uses; be prepared for this. <br />Practice<br />Have your reps role-play these situations at sales meetings so people know how best to address off-label marketing issues. <br />Practice how to handle an unsolicited request--or whatever company-approved process exists for handling these off-label questions--and still provide the education needed for the physician and staff.<br />Participate<br />Make sure that you are spending time in the field with your reps, listening to their presentations and continuously coaching them. <br />Encourage them to call you with any questions about safely and appropriately navigating these off-label questions.<br />http://wp.me/p12znw-yH<br />
  27. 27. The Habitual Mind<br />When something is a habit, the PFC signals the STN at a very low rate<br />Conserves cognitive resources<br />Make decisions more efficiently<br />When doing something different, as simple as looking at dots in a different order, your PFC signals your STN at a very high rate<br />Doing something new or making a difficult decision requires motivation. Without significant motivation, we default to our habits.<br />Prefrontal cortex (PFC) , the “Decider”<br />Controls decision making, including inhibition of reflexive responses<br />Subthalamic nucleus (STN), the “Doer” <br />Controls motivation<br />
  28. 28. Top Off-Label Complaints<br />
  29. 29. Get a Cross-Functional PRC<br />
  30. 30. Follow Good Reprints Guidance<br />
  31. 31. Put Social Media in your SOPs<br />

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