ccc presentation at zinc forum: prt efficiency - turbo-charging commercial and compliance...
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Efficient Promotional Review Process
Efficient Promotional Review Process
Data, Anecdotes, C-Suite Conversations Prove The Point
3 Quantitative Conference Surveys
2010: FDLI – Oct; CBI – June; DIA – May
2 Podium Presentations
2013: Compliance Congress – Jan; DIA – Feb
5,000 +Certification Test Scores
Center for Communication Compliance (CCC)
Developed by former FDA officials (‘08-’12)
CIA and Warning Letter Analysis
Input from industry experts
A Collaborative PRT Quantifiably Impacts Company Success
3
Reduce Waste
Deliver Metrics
Drive Collaboration
Create environment that
protects AND grows the business
Reduce Risk (Compliance Effectiveness)
Increase Sales (Commercial Effectiveness)
Serving Patients and Public Health
Healthy Tension
A Collaborative PRT Quantifiably Fosters Healthy Tension
External Forces
Regulatory/Legal Risks •Known •Evolving •Emerging
Internal Forces
Key to Look Inside at What Makes Company Vulnerable
1. Rewrites
2. Schism
3. Relevance
• Reduce Waste
• Create Metrics
• Increase Collaboration
6
There are Many Known Risks
Traditional FDA marketing enforcement
– More staff; FDCA = authority = fines; Bad Ad
Federal and state enforcement: false claims/anti-kickback
– Whistleblowers; CIAs + Deferred Prosecution
State marketing enforcement under false claims acts
– Use own statutes to bring suits; use warning letters
Private/class action “failure to warn” allegations – Failure to warn = responsible for injuries
Responsible Corporate Officer (RCO) liability
--presidents/CEOs can be convicted/sentenced
--others in ‘responsible relationships’ not immune
Existing Risks Continue to Evolve
OIG/FDA Collaboration
--Warning letters tip off state regulators
Medicare Modernization Act
--Government biggest Rx payer – more fraud/FCA
New Risks Are Emerging
FDA Amendments Act (FDAAA)
-- Empowered with REMS – additional oversight
Affordable Care Act
--Stimulus bill for comparative effectiveness/higher
bar for differentiation with managed care
External Forces
1. Known Legal Risks 2. Evolving Legal Risks 3. Emerging Legal Risks
Internal Forces
Key to Look Inside at What Makes Company Vulnerable
1. Rewrites
2. Schism
3. Relevance
1. Reduce Waste
2. Create Metrics
3. Increase
Collaboration
The Cost of Knowledge and Process Gaps Are Draining Profits
- Regulatory
Knowledge Gaps
- Promotional Review
Process Gaps
Intense
Compliance
Oversight
Promotional
Review
Rigor
$2M+
Hidden Vulnerability #1: Regulatory Knowledge Gaps
40 hours lost monthly by Regulatory
due to rewrites of promotional materials submitted by
promotional agencies without proven acumen
More than 25% of one person’s time is lost to
rewrites
● Doesn’t include time lost by Legal, Medical, Compliance
or Marketing forced to handle rewrites
15 people combined from these functions =
$1 MM waste annually
Agencies spend $100K - $150K annually
on rewrites of own noncompliant materials
Hidden Vulnerability #1: Regulatory Knowledge Gaps (con’t)
● Based on the number of agencies, this can cost
up to $1MM/brand or more annually
● Doesn’t factor in regular agency fees for
material/campaign development
Why so much waste…
● Marketing and agency professionals (even senior
execs) are not knowledgeable about basic
regulations
● Communicating risk, reminder/disease state awareness
ads, spokespeople
Vulnerability #1: Regulatory Knowledge Gaps (con’t)
● Marketing/agencies disagree with Regulatory on
how to implement key initiatives within compliance
● Digital and PR (media tours, releases)
● Promotional education (speaker’s bureaus, slide kits)
● Ad Boards
Brand
Planning
Concept
Execution
PRC
No opportunity to filter out
non-negotiable,
noncompliant elements
BEFORE submission
Revisions Tactical
Execution
Rewrites increase
Slower output
Vulnerability #2: Agencies (& Marketing) Need Pre-Review
Vulnerability #2: Not Every Reviewers is Seasoned (e.g., New Hires)
● Dozen plus review parameters can determine if
piece is compliant (200+ queries = core)
● Review comprehensiveness/efficiency easily
derailed:
■ Typically go line-by-line during in-person review
meetings – would benefit from a “Heat map” to prioritize
disagreements
■ Spend time looking for government documents to prove
their point – would benefit from easier access
■ Keeps functions “swimming in own lane” without silos
■ Experience redundancy/duplication of comments – would
benefit tools that help reviewers “swim in own lane” without silos
■ Level of review experience – new hire, junior
1. Leadership and commitment by senior
management
2. Alignment between promotional regulatory
compliance and marketing communications
3. Monitoring and auditing
4. Enterprise risk management
5. Disciplinary programs and corrective action
protocols
Alignment Sustains Competitive Advantage in Compliant Culture
Myths/Misconceptions Affecting Collaboration
Examples of Misaligned Beliefs
Compliance thinks: Commercial thinks:
On goals and
objectives
They don’t understand the implications
of non-compliant materials
They doesn’t understand that my sales
forecast is going to be really difficult
for me to achieve this year
On being
under pressure
I can be held personally responsible if
we get in trouble, which can result in
fines or even jail time
I’ll get a bad review and no promotion
if I don’t make my numbers
On adequate
information
Some claims/promotional themes are
simply not negotiable as they are
emphatically violative
We are at a disadvantage when
competitors promote in ways that
we’re not allowed
On
communication
They think I can always give them an
instant answer
They say no before they even listen
to the idea
On moving
forward
We seem to have the same
conversation over and over They don't give me alternatives
Increase marketing budget X% by converting
wasted agency fees to production of more
promotional materials
PRT Can Prove Its Value to Business With Metrics
Increase # of promotional campaigns/materials
approved by team X% without compromising
review comprehensiveness
Brand
Planning
Concept
Execution
PRC
Filter out non-negotiable,
noncompliant elements BEFORE
submission
Revisions Tactical
Execution
Rewrites minimized
Faster output
Reduce Number of Non-Compliant Materials From Entering System
● Business Acumen Tools
● Training
Benchmark, Engage, Measure
Marketing/Agencies
understand
Regulatory basics
Compliance
functions understand
needs of business +
● Knowledge KPIs
● Pre-review Screening
Systems
● Collaboration Protocols
Effective Collaboration is Crucial
Mindset
Leadership development /
Personality Analyses
Infrastructure, technology platforms and process
Needed to create enduring cultural change
Key for strategic thinking, listening, coaching, cross functional knowledge, softer skills
Critical to break down silos
Address root cause for collaboration challenges
The path forward requires a change in behaviors and attitude in order to successfully affect
behaviors and cultures across functional boundaries to match the business objectives
Efficient Promotional Review Process
Efficient Promotional Review Process
• Millions
• Metrics
• Mindset
BFF
Compliance (2012 Congress)
• Measure effectiveness of compliance program
• Prove compliance programs are relevant to business
Marketing
• Drive revenue
HR and Training
• Enduring Culture Change w/ Integrity Mindset
PRT
• Recognition it deserves
Contact Information
Ilyssa Levins, President
Center for Communication Compliance (CCC)
p: 212-361-9868, f:212-980-3760
www.CommunicationCompliance.com
www.Twitter.com/ILatCCC