Preventing Off-label Sales Promotion

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

Deleterious Duo: Off-Label Sales Communications and Product Liability
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.

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; kcornish@navigant.com

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.

400x More Individuals; 50% Mgmt
Jailing Individuals: What’s Next in Fraud and FCPA

40% Drop in Stock Price Overnight
DOJ probe
$3.8M & CIA
AtriCure stock plunges amid marketing probe. Wall Street Journal, 11/04/2008.

Standard seven compliance recommendsgood starting Point; rethink for sales environment

Standard Seven OIG Recommends
Standards and Procedures
Oversight
Education and Training
Auditing and Monitoring
Reporting
Enforcement and Discipline
Response and Prevention
www.ussc.gov
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?
1
*9 Notable Insights from AMEX

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

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
3

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?
4

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 corpcomm or marketing, e.g. weekly texts
Reading paper does not equal compliance
5
Keeping Companies Out of Trouble: Notes from Google’s and UPS’ Compliance Programs

When: Ongoing & Sustainable
6

Make On-Message Easier than Off
7
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

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

Contact Information
Maureen Shaffer Vice President, Life Sciences, Prolifiq
maureen.shaffer@prolifiq.net
www.prolifiq.net/lifesciences
415-341-6863 mobile
Executive Editor & Publisher, Good Promotional Practices
maureen.shaffer@goodpromotionalpractices.com
www.goodpromotionalpractices.com
www.linkedin.com/in/maureenashaffer
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.
http://wp.me/p12znw-yH

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 responses
Subthalamic 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

Preventing Off-label Sales Promotion

by Good Promotional Practices on May 12, 2011

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