Instilling Quality in Promotional Materials from

Start to Finish: Effective Collaboration with

Marketing and Media Companies

Advertising and Promotion Conference  October 2, 2012 

  Capitol Hilton Hotel | Washington, DC

Let’s discuss…

• How marketing, public relations and media partners/internal communications teams can effectively collaborate with regulatory departments to ensure:– FDA rules are met– Effective collaboration to create quality

promotions

Today’s Panel

• Hamish Miller, Director of US Operations, Zinc Ahead, LTD

• Ilyssa Levins, President and Founder, Center for Communication Compliance

• Alan Bergstrom, Senior Director, Commercial Regulatory Affairs, Daiichi Sankyo, Inc.

• Preeti I. Pinto, President, Preeti Pinto and Associates, LLC

• Moderated by John J. Seng, President & CEO, Spectrum

John J. Seng

President, Spectrum

Chair, GLOBALHealthPR

Communications 101

What the RFP says…

…creative means of

generating product

demand and

establishing market.

…developing a launch

plan to maximize

exposure and

differentiation…

Ensure that new data

on the product are

communicated.

…is actively searching for a

highly creative, strategic and

results-oriented public

relations agency…

perform with nimbleness and

agility…Elevate the urgency of

aggressive and early

treatment of “condition”

PR agencies will

push the limits

A complex regulatory

patchwork

Regulatory pushes zero tolerance

Understanding Goals of Both Parties

Communicator

Inspire actionIncrease awareness

Educate, empower the public

Regulator

Guarantee safetyEnsure fairnessSafeguard compliance

At the end of the day…

Improve health and wellbeing via commercialized

products

Start off on the right foot

Takeaways from the PR firm perspective

1. Align marketing, public relations, regulatory and corporate procurement from the start

2. Clearly outline roles and responsibilities on the customer side

3. Ensure that requests for work are compliant

4. Define and encourage 360 training as appropriate

Thank you.John J. Seng | jjs@spectrumscience.com

Founder and President, Spectrum Founder and Chair, GLOBALHealthPR

www.spectrumscience.com |www.globalhealthpr.com

@JohnJSeng | @Spectrumscience

Hamish Miller

Director of US Operations, Zinc Inc.

Agenda

• Share a number of key trends and pose a number of questions– Review times– Cancellations– Review rounds– SOP’s

“Quality means doing it right when no one is looking”

Scope of Data

• Over the last 11 years we’ve observed varying degrees of quality within the promotional review processes in over 165 Countries

Scope of Data

• We have seen in excess of 500,000 pieces of material start the promotional review process globally

Common Objectives / Challenges

• Compliance• Transparency / accountability• Collaboration, approval and sharing of

material• Version control, expiration & re-approval of

material

Unique Objectives / Challenges

• There are big differences by region

Unique Objectives / Challenges

• There are big differences by region• BUT we also see big differences within regions…

Average Review Times (Days)- Industry

Average review times in the US are in the region of 25 days

Average Review Times (Days)

Some companies can take 40 + days; while others take as little as 7 days

% cancelled during review- Industry

Around 15% of material sent out for review is subsequently cancelled

% cancelled during review

We also see some companies cancelling over 35% and some companies

cancelling as little a 7%

Average # of review rounds- Industry

The average number of review rounds is two

Average # of review rounds

With some companies taking over three…..

Summary

• Why do we see such big differences in US?• Why do some companies take twice the industry

average to review material?• Why is 15% of material consistently cancelled?• Why do some companies take 3.5 rounds of review to

get material approved?• Why do 40% of companies not have clear SOP’s in

place?

Thank you

Participate and Receive Benchmarking Data:

HamishMiller@Zinc-Ahead.com

Closing Knowledge Gaps

Ilyssa Levins, President

Center for Communication Compliance (CCC)

Benchmark Data

Conference SurveysRx Compliance Report

FDLI - October 2010

CBI - June 2010

DIA – May 2010

Test Scores

Center for Communication Compliance (CCC)

Mined from certification test score databaseConversations

Senior industry leadership: pharma companies and agencies

Knowledge Gaps: Agencies

• One-third of participating PR agency staff (32%) failed 12-question test after 3 attempts

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Passed on third attempt: 68%

Average score: 81% (80% score required to pass)

Test takers were mid to senior level executives (2008 baseline)

Knowledge Gaps: Types of Questions Marketing Agencies Get Wrong

Q: Indicate which two statements reflect the PhRMA Code in regard to third-party spokespeople:

A. Third-party spokespeople may not be paid to speak with the media

B. Third-party spokespeople must have published in peer-reviewed journals on the subject area on which they are speaking for the company

C. The total number of spokespeople in a speaker's bureau must correlate with what is needed to achieve the firm’s business purpose (correct)

D. The spokesperson services contracted for must meet a legitimate and documented need, and payment should represent the fair market value for services provided (correct)

E. Every consultant who speaks for a company in support of a prescription drug must have an MD, a PhD, or a PharmD degree

–  

*Ad/promo, PR, PRM, Digital, Promo

med ed

Knowledge Gaps: Types of Questions Marketing Agencies Get Wrong

Q. Which of the following features of a company's product Web site does the FDA regard as potentially being subject to its enforcement authority?

A. Statements or conclusions about product safety and/or efficacy for drugs still under investigation

B. Lack of fair balance in promotional information about approved products

C. Links to other sites that contain promotional information about uses that are off-label for a product

D. For drugs that have already been approved outside of the U.S., information about the product that might be allowable in those countries but is misleading on a Web site accessible by U.S. residents

E. All of the above (correct answer)

 •  

*Ad/promo, PR, PRM, Digital, Promo

med ed

Knowledge Gaps: Types of Questions Marketing Agencies Get Wrong

Q: A promotional press release issued at the time that a new product is being launched must:

A. Be cleared by DDMAC before issuance

B. Be shared with the FDA Press Office before issuance

C. Discuss all the major research being conducted on the product

D. Contain a "fair balance" of the benefits of the product and its risks (correct answer)

E. All of the above

F. None of the above 36 *Ad/promo, PR, PRM, Digital,

Promo med ed

Knowledge Gaps: Types of Questions Internal Marketing Departments Get Wrong

Summary of question ‘topics’ missed:• Risk communication• Pre-submission requirements • Reminder and disease state awareness ads• Use of spokespeople

37

Schism

• Greatest disconnects between regulatory, marketing and agencies occur with:

1. Digital communications

2. Public Relations• Media tours• Press releases

3. Promotional Education• Speaker’s bureaus• Slide kits

4. Advisory Boards

38

Hours Lost to Rewrites

• 76% of promotional regulatory professionals say:

21 - 40 hours lost monthly rewriting promotional materials submitted by untrained agencies

• With 1800 working hours/year, > 25% of regulatory’s time

39

Take-away #1: Agency Knowledge Gaps Cost Too Much

• Time Lost By Regulatory Professionals– $200,000 in staff time yearly

• Does not include legal, medical, compliance, marketing

40

Take-away #1: Agency Knowledge Gaps Cost Too Much (continued)

• Time Wasted by Agency Staffers – $100,000/year/brand in agency billings

41

Take-away #2: Devil is in Details

Drill down into the diverse disciplines

Yes to ad/promo, but also:

– PR, promotional education, patient relationship marketing, digital

Educational strategy

Focus on how to execute compliant tactics

Confirm mastery of knowledge yearly

Identify and address specific areas of misunderstanding

77% of regulatory professionals are concerned that agency programs and materials could be sources of trouble in litigation

Marketing

Efficiency

Marketing

Effectiveness

Fewer non-starters;

(more useable big ideas)

More time to optimize claims

More time to review other

products in queue

Sales materials in market

quicker

Fewer campaigns pulled

Accelerated

transfer of balanced

health information

Protects and enhances

public health

Fewer rewrites

Shorter review cycles

Less drain on

resources

Healthier marketing

budgets by reducing

vendor costs

Take-away # 3: Regulatory is High Value Partner to Commercial

Close knowledge gaps = greater marketing excellence = ally

Marketing

Impact

Closing Knowledge Gaps

Ilyssa Levins, President

Center for Communication Compliance (CCC)

ilevins@CommunicationCompliance.com

212-361-9868

Addendum: Calculations• Time Lost By Regulatory Professionals due to noncompliant agencies

– $200,000 in staff time yearly• Assumptions

-Average 12 review cycles/processes/year for one brand-Average cost of regulatory professional = $150/hr-Regulatory reviews work submitted by three agencies

• Calculations–$150/hr. X 21-40 hours = $3,150-$6,000/month–$3,150-$6,000/month X 12 review cycles = $37,800-$72,000 –$37,800-$72,000 X 3 agencies = $113,400-$216,000

• Time Wasted By Agencies due to noncompliance– $100,000/year/brand in agency billings

• Assumptions–Average cost of agency professional = $100/hr.–Minimally, three staff assigned to brand = $300/hour

• Calculations–$300/hour X 21-40 hours = $6,300-$12,000 per review cycle–$6,300-$12,000 X 12 review cycles = $75,600-$144,000

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Instilling Quality in Promotional Materials from

Start to Finish: Effective Collaboration with

Marketing and Media Companies

Advertising and Promotion Conference  October 2, 2012 

  Capitol Hilton Hotel | Washington, DC

Improving Quality and Reducing Waste Through

Agency/Company Partnership

Alan Bergstrom, Senior Director

Commercial Regulatory Affairs

Daiichi Sankyo, Inc.

Disclaimer

The content, views, and opinions in this presentation are my own and do not in

anyway represent the views or opinions of Daiichi Sankyo, Inc.

More Quality, Less WasteR

egu

lato

ry

Mar

keti

ng

/Ag

ency

Change

Process

Pinpoint

Knowledge

Gaps+

Qualify

Staff+

The Current Process

Brand

Planning

Brand

Planning

Concept

Execution

Concept

Execution

PRCPRC

Concept reviews traditionally

take place here

Regulatory typically not involved in Core Brand Team

RevisionsRevisions Tactical

Execution

Tactical

Execution

Broken Internal System

Brand

Planning

Brand

Planning

Concept

Execution

Concept

Execution

PRCPRC

Regulatory was not involved earlier to discuss proposed strategies/tactics … or

vet post marketing medical affairs studies to be sure they support claims

Substantial time, effort and

money spent by the agency

RevisionsRevisions Tactical

Execution

Tactical

Execution

Marketing presents ideas

to senior management who

questions tactics, BUT …

Agencies Fuel the Waste

Brand

Planning

Brand

Planning

Concept

Execution

Concept

Execution

PRCPRC

Agencies hatch big ideas with few

regulatory compliance parameters

Non-starter’ ideas get explored and

expanded

RevisionsRevisions Tactical

Execution

Tactical

Execution

Agency develops noncompliant

campaigns embraced by marketing as

differentiating

Marketing drains

PRC resources with

unnecessary reviews

Agency rewrites materials at cost to

the company

Lengthy review process slows

down marketing execution

Opportunity: Improving the Process

Brand

Planning

Brand

Planning

Concept

Execution

Concept

Execution

PRCPRC

Substantial evidence = regulatory decision NOT marketing or medical affairs

Need data dump at study conclusion for all PRC reviewers BEFORE

promotional tactics are developed and presented to PRC

RevisionsRevisions Tactical

Execution

Tactical

Execution

Regulatory reviewer has already determined that data is

substantial and doesn’t overstate safety or efficacy

Opportunity: Improve the Process

• Clear expectations for review authority, decision making stops ‘shopping for answers’

Regulatory is deep dive expert on regs

First stop for related answers

Legal focuses on issues over/above FDA regs

Lanham Act, False Claims, etc.

Medical focused on review of medical support

for claims

Medically appropriate in practice of medicine

not always considered substantial

evidence by regulatory

Regulatory should avoid questioning

medical/legal analysis … but

conclusions fair game

Education for Everyone Gets

Everyone on Same Baseline

Marketing, Managed Care, Sales, Agencies … And Regulatory

Train to teach

fundamentals

Test to confirm

fundamentals

Opportunity: Close Knowledge Gaps

Qualify

Marketing

and Agency

Partners

Preeti Pinto

Preeti Pinto and Associates, LLC

So

To reduce waste and increase value, we:

Have educated ad agencies/commercial staff

Are included in the concept phase

Now let us change marketing behavior

Have clarified roles and responsibilities

Best PracticesTake joint accountability for

Optimizing claims

Regulatory compliance

Efficient processes

Communicate clearly

Comments understood?

Comments actionable?

Comments recommend an alternate solution that addresses business needs?

Develop regulatory guidances/processes

Guidance Development

Prototype Development

Regulatory

Considerations

New Platform or

Tactic

Regulatory and Legal

Considerations

Guidance and Process

Development

Marketing Considerations

Identification of regulatory hurdles

before signing contract

Consistent Application to All TAs

and Brands

Best Practices

Clinical Trial Design

Promotional

Piece

Copy Review

Concept

Pre-Concept

Creative Development

Market Research

Regulatory Guidance Development

Clear Communication

Joint Accountability

Target Profile

Gave examples of few best practices

More best practices can be implemented

Win win for all

Team meetings could be spent optimizing claims and promotional value of the piece

instead of “lack of substantial evidence” and “where is the fair balance.”