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