1

Why Pursue A Career in Healthcare PR?

Ilyssa Levins, President and FounderCenter for Communication Compliance

212.361.9868

2

■NYU grad like you

■35 years in healthcare

■Worked through ranks

Why Me

3

Our Focus Today

4

■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

5

6

■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

7

■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

8

■You can learn by osmosis

■Science can be intimidating

■Good writing is critical, as always

Learn the Lingo: Science Background Not Required

9

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

10

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

11

■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

12

■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

14

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

15

Healthcare Professionals

Physician

Nurse

Behaviorial Psychologists

Pharmacist

Payer

Many Stakeholders

16

Clients

Marketing

Managed Care

Market Research

Communications

Clinical and R&D

Many Stakeholders

17

■ 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

18

■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

19

■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

20

■ 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

21

■FDA■OIG■PhRMA■AMA■ACCME■Advamed

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

22

■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

23

FDA

More than just drug approval

24

■ 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

25

■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

26

OIG

The new big stick

27

■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

28

■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

29

PhRMA

Drives industry self-regulation

30

■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

31

AMA

Professional standards

for physicians

32

ACCME

Protects integrity of Continuing Medical Education

33

AdvaMed

Drives self-regulation in the medical technology and device

industry

34

■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

35

■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