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)

ilevins@communicationcompliance.com

p: 212-361-9868, f:212-980-3760

www.CommunicationCompliance.com

www.Twitter.com/ILatCCC