hot areas in marketing: why pursue a career in healthcare pr?
DESCRIPTION
Presentation made by Ilyssa Levins at NYU on October 5, 2011 to the Master's Program class of "Public Relations Specialties," taught by PR veteran Saralie Slonsky. In the 35 slides included here, Ilyssa describes her career path and the industry itself. She founded her company, Center for Communication Compliance, in 2008 which offers pharmaceutical and medical device companies training and certifications in regulatory compliance. www.communicationcompliance.com For more information and specific PR case histories, contact Ilyssa at [email protected] Class Description: http://www.scps.nyu.edu/course-detail/PRCC1-GC2220/20113/public-relations-specialtiesTRANSCRIPT
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
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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
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
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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
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
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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
23
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
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
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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
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