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Why Pursue A Career  in Healthcare PR? Ilyssa Levins, President and Founder Center for Communication Compliance 212.361.9868
NYU grad like you 35 years in healthcare  Worked through ranks Why Me
Our Focus Today
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
 
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
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
You can learn by osmosis Science can be intimidating  Good writing is critical, as always Learn the Lingo:  Science Background Not Required
The world in which you operate Document need Validate science Establish value/quality Drive demand Phase 1 Phase 2 Phase 3 Trials Approval Survival Window Go/ no Go Unleash advocates Maximize sales Year 1 Year 2 Month 6
Issues Enhance Advocacy & Media Relations Tell me a story [ ISSUE] CLIENT GET MY BRAND  IN THE NEWS [ brand ] TELL ME  A STORY [ issue ] MEDIA 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
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
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
The Tactics Professional Association Newsletters “ Hometown” Local Media Advocacy “ Grapevine” Medical Meeting Events Awards Magazine Supplement Pharmacy Events/Education Consumer Media Push (health, lifestyle, business) Consumer Association Newsletters Professional Journal Media Relations News-making Issue
Leverage the Power of Advocacy Relationship Audit Lend a Hand Before Asking Advocates for Help Recommendations for Partnerships Shared Agenda Define brand messages in positive terms Diffuse impact of dissenting voices Neutralize negative situations Communicate to additional allies White Papers Hearings Letters Events Articles Clinical Trials
Many Stakeholders Healthcare Professionals Physician Nurse Behaviorial  Psychologists Pharmacist Payer
Many Stakeholders Clients Marketing Managed Care Market Research Communications Clinical and R&D
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
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
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
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
FDA OIG PhRMA AMA ACCME Advamed Agencies/Organizations Who  “Regulate” Promotion of Rx Drugs and Devices
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
FDA More than just drug approval
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
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
OIG The new big stick
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
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
PhRMA Drives industry self-regulation
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
AMA Professional standards  for physicians
ACCME Protects integrity of Continuing Medical Education
AdvaMed Drives self-regulation in the medical technology and device industry
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
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

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Hot Areas in Marketing: Why Pursue a Career in Healthcare PR?

  • 1. Why Pursue A Career in Healthcare PR? Ilyssa Levins, President and Founder Center for Communication Compliance 212.361.9868
  • 2. NYU grad like you 35 years in healthcare Worked through ranks Why Me
  • 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 Phase 1 Phase 2 Phase 3 Trials Approval Survival Window Go/ no Go Unleash advocates Maximize sales Year 1 Year 2 Month 6
  • 10. Issues Enhance Advocacy & Media Relations Tell me a story [ ISSUE] CLIENT GET MY BRAND IN THE NEWS [ brand ] TELL ME A STORY [ issue ] MEDIA 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
  • 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
  • 13. The Tactics Professional Association Newsletters “ Hometown” Local Media Advocacy “ Grapevine” Medical Meeting Events Awards Magazine Supplement Pharmacy Events/Education Consumer Media Push (health, lifestyle, business) Consumer Association Newsletters Professional Journal Media Relations News-making Issue
  • 14. Leverage the Power of Advocacy Relationship Audit Lend a Hand Before Asking Advocates for Help Recommendations for Partnerships Shared Agenda Define brand messages in positive terms Diffuse impact of dissenting voices Neutralize negative situations Communicate to additional allies White Papers Hearings Letters Events Articles Clinical Trials
  • 15. Many Stakeholders Healthcare Professionals Physician Nurse Behaviorial Psychologists Pharmacist Payer
  • 16. Many Stakeholders Clients Marketing Managed Care Market Research Communications Clinical and R&D
  • 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

Editor's Notes