hot areas in marketing: why pursue a career in healthcare pr?

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Why Pursue A Career in Healthcare PR?

Ilyssa Levins, President and FounderCenter for Communication Compliance

212.361.9868

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■NYU grad like you

■35 years in healthcare

■Worked through ranks

Why Me

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Our Focus Today

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■Healthcare PR:

● Helps save lives – opportunity to give back

● Is a highly specialized niche

● Requires a very broad and deep skill set

● Demands effective crisis management skills

● Means operating under intense scrutiny because there are so many regulations

What You Need to Know To Make A Decision

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■You are right in the middle of very hot topic

■Political, economic, patient empowering

● Access to healthcare

● Patient centered healthcare

● Healthcare reform

Trends in Healthcare

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■Healthcare PR:

● Helps save lives – opportunity to give back

● Is a highly specialized niche

● Requires a very broad and deep skill set

● Demands effective crisis management skills

● Means operating under intense scrutiny because there are so many regulations

What You Need to Know To Make A Decision

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■You can learn by osmosis

■Science can be intimidating

■Good writing is critical, as always

Learn the Lingo: Science Background Not Required

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The world in which you operate

Document need Validate science Establish value/quality Drive demand

Phase1

Phase2

Phase3

Trials

Approval SurvivalWindow

Go/ no Go

Unleash advocates

Maximize sales

Year1

Year2

Month6

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Tell me a story

[ ISSUE]

CLIENTCLIENTGET MY BRAND GET MY BRAND

IN THE NEWSIN THE NEWS[[brandbrand]]

TELL ME A TELL ME A STORYSTORY[[issueissue]]

MEDIAMEDIA BREAKING NEWS

HUMAN INTEREST/LIFESTYLE

• Pivotal research published in major journal• Medical consensus guidelines• Approval/new claim• Crisis

• Quantifiably improved

quality of life• Celebrity link• R&D trends• Scientific

discoveries• Case history

(grassroots)

BUSINESS

• Earnings• Marketplace overview• Management profiles• Trends

A D V O C A C Y

Issues Enhance Advocacy & Media Relations

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■Healthcare PR:

● Helps save lives – opportunity to give back

● Is a highly specialized niche

● Requires a very broad and deep skill set

● Demands effective crisis management skills

● Means operating under intense scrutiny because there are so many regulations

What You Need to Know To Make A Decision

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■Write a press release■Create B-roll■Contact an advocacy group■Negotiate with a celebrity■Develop a radio series■Craft a tough Q&A■Execute an event■Pitch the media■Talk to an investigator■Release a white paper■Make a client presentation

Day in the Life

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Relationship Audit

Recommendations for PartnershipsShared Agenda

Define brand messages in positive termsDiffuse impact of dissenting voices

Neutralize negative situationsCommunicate to additional allies

WhitePapersHearingsLetters EventsArticles

Clinical Trials

Lend a Hand Before Asking Advocates for Help

Leverage the Power of Advocacy

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Healthcare Professionals

Physician

Nurse

Behaviorial Psychologists

Pharmacist

Payer

Many Stakeholders

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Clients

Marketing

Managed Care

Market Research

Communications

Clinical and R&D

Many Stakeholders

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■ Tough to be truly interactive

■ But must have online presence

● Digital content push

– Little exchange

● Analysis and monitoring

– Twitter – what everyone is saying

Preparedness tool

News bits

Engage in dialogue (disease awareness)

One Note: Social Media

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■Healthcare PR:

● Helps save lives – opportunity to give back

● Is a highly specialized niche

● Requires a very broad and deep skill set

● Demands effective crisis management skills

● Means operating under intense scrutiny because there are so many regulations

What You Need to Know To Make A Decision

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■Side effects cause patient death■Clinical trial fails■Competitor mounts attack■Company gets sued■Physician spokesperson indicted■Drug poorly positioned■Patient sues company■Class action suit

Crisis Management

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■ Scenario planning

■ Key messages

■ Press releases for each scenario

■ Holding statements

■ Spokesperson development

■ B-roll

■ Internal tool kit and execution

■ Media strategy and execution

What Happens

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■FDA■OIG■PhRMA■AMA■ACCME■Advamed

Agencies/Organizations Who “Regulate” Promotion of Rx Drugs and Devices

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■FDA● Warning letters

● Untitled letters

● Corrective programs

■OIG● Serious fines

● Criminal charges against individuals and companies

● Possible disbarring of the company from selling products to the government

■PhRMA, AMA, ACCME, AdvaMed● Negative publicity, product liability

● PhRMA Code part of state law in a number of states

■Employee litigation – whistleblower lawsuits

Risks of Violations

Damage to reputation

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FDA

More than just drug approval

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■ Over all product-specific promotional materials issued by or on behalf of a drug, biotechnology, or medical device company● Advertisements in all media

● Press releases, VNRs, brochures

● Slide kits, letters to physicians, reprints

● Video and audio tapes

● Meetings

● Formulary materials

● Media tour materials

● All materials used by sales force, e.g., VisAids

● Oral presentations by sales force

● Third-party statements (e.g., by physicians or other speakers hired by company)

● Internet (Web sites owned or sponsored by companies)

Law is criminal: violators have personal liability and can face criminal prosecution

FDA Authority

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■Promotional activities must:● Be within FDA-approved labeling

● Reveal all material facts about the product

● Be fairly balanced

● Include full prescribing information (PI) for all materials (other than ads, which must have a brief summary of risks)

FDA General Rules

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OIG

The new big stick

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■When company promotes off-label,

and

■Then physician prescribes product for off-label use,

and

■Then government pays (reimburses) for that off-label use under one of its programs

OIG Legal Theory (False Claims Act/Anti-Kickback Statute)

This is fraud against the government

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■Whistleblowers get 15-30% of settlement fine

■Recent cases have changed hiring and HR practices in drug/device companies, as well as how they deal with complaints internally

How OIG Cases Develop

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PhRMA

Drives industry self-regulation

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■Establishes the relationship between physicians and other healthcare providers and the drug industry

● Gifts not of educational value prohibited

● Further restrictions on meals - cannot take place at restaurants, but can bring in meals

■Has become industry goal/standard

● Adopted as state law

PhRMA Code on Interactions with Healthcare Professionals

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AMA

Professional standards

for physicians

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ACCME

Protects integrity of Continuing Medical Education

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AdvaMed

Drives self-regulation in the medical technology and device

industry

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■Healthcare PR:

● Helps save lives – opportunity to give back

● Is a highly specialized niche

● Requires a very broad and deep skill set

● Demands effective crisis management skills

● Means operating under intense scrutiny because there are so many regulations

What You Need to Know To Make A Decision

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■Professional and personally fulfilling

■Paths

■Opportunity to grow with small agency

■Larger agency provides foundation

■Corporate (drug or device side) creates perspective

■Offshoots

■Event management

■Pure media relations

■Advocacy relations

■ Investor relations

■Managed markets

Final Thoughts