Preventing Off-label Sales Promotion

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Maureen Shaffer

Vice President, Life Sciences, Prolifiq

www.prolifiq.net/lifesciences

Executive Editor & Publisher, Good Promotional Practices www.goodpromotionalpractices.com

Preventing Off-Label Sales Promotion

First presented at AdvaMed EGCC on 05/03/2011

http://www.prolifiq.net/lifesciences

http://www.goodpromotionalpractices.com/

http://www.advamedegcc.org/

©2011 Good Promotional Practices and Prolifiq Software, Inc. All Rights Reserved.3

Disclosures

Good Promotional Practices is sponsored by Prolifiq and Reprints Desk

Prolifiq is an AdvaMed Business Solutions Partner


Sales: Off-Label HCP Promotion

Image courtesy of Navigant: Life Science Product Value Preservation in a Changing Sea of Liability Risk; [email protected]

http://www.navigant.com/insights/library/healthcare/heathcare%20di/life_science_product_value_pre/

mailto:[email protected]


Agenda

Off-Label Sales Promotion–It’s All About the Numbers

Standard Seven Compliance Recommends–Good Starting Point–Rethink for Sales Environment

Seven Insights to Preventing Off-Label Sales Promotion


OFF-LABEL SALES PROMOTIONALL ABOUT THE NUMBERS


70% Whistleblowers are Sales


92% DOJ Convictions are Small Cos

•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.”

•“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.”

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.

http://t.co/HbaOLXG

http://www.rxcompliancereport.com/sample/RxCompSampleIssue.pdf

http://www.rxcompliancereport.com/sample/RxCompSampleIssue.pdf


400x More Individuals; 50% Mgmt

Jailing Individuals: What’s Next in Fraud and FCPA

http://wp.me/p12znw-wI


40% Drop in Stock Price Overnight

AtriCure stock plunges amid marketing probe. Wall Street Journal, 11/04/2008.

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$3.8

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STANDARD SEVEN COMPLIANCE RECOMMENDSGOOD STARTING POINT; RETHINK FOR SALES ENVIRONMENT


Standard Seven OIG Recommends

1. Standards and Procedures

2. Oversight

3. Education and Training

4. Auditing and Monitoring

5. Reporting

6. Enforcement and Discipline

7. Response and Prevention

www.ussc.govwww.oig.hhs.gov

http://www.ussc.gov/

http://www.oig.hhs.gov/


Sales is Mobile, Verbal, Efficient=$


Compliance: Yielding w/o Disruption


SEVEN INSIGHTS TO PREVENTING OFF-LABEL SALES PROMOTION


Hire Integrity and Team Players

Hiring is everyone’s job--Google

Cross-functional team interviews

Respectful of their colleagues’ environments?–No sales prevention or regulatory roadblocks

Past cross-functional interactions and references?

Independent*, clean background and social media checks?

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*9 Notable Insights from AMEX

http://wp.me/p12znw-wV


Listen and Respond

Only 3% call the hotline–Symantec, low #s for Google and MDT

But, 75% take the problem to their manager–Symantec

“50% of fraud whistleblower cases could have been prevented if someone had listened, responded and investigated proactively”

–Whistleblower Action Network

2

Dow-Jones Global Compliance Symposium

http://www.goodpromotionalpractices.com/events


Off-Label Education: Who

Tone at the middle (Intel and AIG)

Interwoven throughout organization

–Video from CEO doesn’t do it

Sales managers train their managers who train their managers

–Living the story–Repetition creates memory and belief

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Off-Label Education: Back to Basics

Are your oral and written statements:–Truthful and non-misleading–Fair balance between benefit and risk–Communication of material facts

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?

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Off-Label Education: How

Verbal: Role-playing before and after–New launches–Major scientific meetings–New scientific studies–Mandate in ride-alongs and document

Mobile is Efficient=$: Incorporate learning with quick, regular communications

–Work with corp comm or marketing, e.g. weekly texts–Reading paper does not equal compliance

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Keeping Companies Out of Trouble: Notes from Google’s and UPS’ Compliance Programs

http://wp.me/p12znw-wh


When: Ongoing & Sustainable6


Make On-Message Easier than Off7

Latest and greatest materials?

Easy to submit request for article?

Off-label scientific requests?

Real-time compliance questions Keeping Companies Out of Trouble

Poll data courtesy of Prolifiq

http://wp.me/p12znw-wh



Excellent Resources

Your own sales force or distributors–http://wp.me/p12znw-yH

Good Promotional Practices–www.GoodPromotionalPractices.com

AdvaMed MTLI courses–www.advamedmtli.org

RAPS.org–www.raps.org

Dow Jones Global Compliance Symposium–www.gcs.dowjones.com

http://wp.me/p12znw-yH


http://www.advamedmtli.org/

http://www.raps.org/

http://www.gcs.dowjones.com/


Contact Information

Maureen Shaffer Vice President, Life Sciences, Prolifiq

[email protected]

www.prolifiq.net/lifesciences

415-341-6863 mobile

Executive Editor & Publisher, Good Promotional Practices

[email protected]

www.goodpromotionalpractices.com

www.linkedin.com/in/maureenashaffer

www.twitter.com/maureenshaffer





http://www.linkedin.com/in/maureenashaffer

http://www.twitter.com/maureenshaffer


Real-Life Ideas for Sales Managers

Educate–Your reps need to know what uses are approved/cleared and what is off-label. –Before your quarterly sales meetings, review current best practices and

emerging uses occurring in the field–Surgeons will often come back from a society meeting having talked to their

colleagues about new uses; be prepared for this.

Practice–Have your reps role-play these situations at sales meetings so people know how

best to address off-label marketing issues. –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.

Participate–Make sure that you are spending time in the field with your reps, listening to

their presentations and continuously coaching them. –Encourage them to call you with any questions about safely and appropriately

navigating these off-label questions.




The Habitual Mind

When something is a habit, the PFC signals the STN at a very low rate

–Conserves cognitive resources–Make decisions more efficiently

When doing something different, as simple as looking at dots in a different order, your PFC signals your STN at a very high rate

–Doing something new or making a difficult decision requires motivation. Without significant motivation, we default to our habits.

Prefrontal cortex (PFC) , the “Decider”Controls decision making, including inhibition of reflexive responsesSubthalamic nucleus (STN), the “Doer” Controls motivation


Top Off-Label Complaints


Get a Cross-Functional PRC


Follow Good Reprints Guidance


Put Social Media in your SOPs

Health & Medicine

Preventing Off-label Sales Promotion