SlideShare uma empresa Scribd logo
1 de 18
Staying Compliant in a
Social World
Presented by Dale Cooke
2
The 14 letters from 2009
3
Nov ’09 Part 15 Hearings & FDASIA
Five questions:
> What online communications are sponsors
responsible for?
> How can sponsors fulfill regulatory obligations in
social media (2253 filings, fair balance, etc.)?
> What should sponsors do about corrective
messaging?
> When are links appropriate?
> How should sponsors deal with AERs?
FDASIA mandate to produce guidance by July 2014
4
Social media guidance is here
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM
381352.pdf
See also, http://www.scribd.com/doc/199434412/DH-Regulatory-Alert-2253-Filing-Requirements-
for-Social-Media
Released January 2014
5
Nov ’09 Part 15 Hearings & FDASIA
Five questions:
> What online communications are sponsors
responsible for?
> How can sponsors fulfill regulatory obligations in
social media (2253 filings, fair balance, etc.)?
> What should sponsors do about corrective
messaging?
> When are links appropriate?
> How should sponsors deal with AERs?
FDASIA mandate to produce guidance by July 2014
6
Additional guidance to come
7
What is a guidance?
“Guidance documents represent the Agency's current thinking on a
particular subject. They do not create or confer any rights for or on
any person and do not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute, regulations, or both.”
- From the FDA website
8
But it’s only draft
9
What are postmarketing submissions?
All promotional materials must be submitted to FDA at
the time of initial dissemination (i.e., the 2253
submission).
This guidance addresses two questions about the 2253
submission:
1. Whether to submit materials
2. What to submit
10
User-generated content
“a firm generally is not responsible for UGC that is truly
independent of the firm (i.e., is not produced by, or on
behalf of, or prompted by the firm in any particular)”*
* Postmarketing Guidance, page 5.
11
Determining whether to submit
Three sets of circumstances:
1. Sites “owned, controlled, created, influenced, or
operated by, or on behalf of the firm…. even if the
influence is limited.”*
2. Site pages if the firm “influenced the placement” of
promotional materials.**
3. When agents or employees are “acting on behalf of
the firm”**
* Postmarketing Guidance, page 3.
** Postmarketing Guidance, page 4.
12
Enforcement discretion
“If a firm submits interactive promotional media in the
manner described in this draft guidance, FDA intends to
exercise enforcement discretion regarding the regulatory
requirements for postmarketing submissions related to
promotional labeling and advertising.”*
Enforcement discretion means:
1. FDA has the legal authority to enforce legal and
regulatory requirements in that area.
2. FDA will not use that authority.
* Postmarketing Guidance, page 5.
13
Applying discretion to social media
Firms have a legal obligation to submit all parts of a
conversation prior to using them, but FDA will not take
enforcement action against companies that fail to do so,
IF THEY ABIDE BY THIS GUIDANCE.
14
What to submit
1. For static materials with interactive components, submit static
and indicate what changes (e.g., which portion of the website
houses an online discussion forum)
2. For third-party sites, submit static elements with first
communication (e.g., first Tweet & Twitter profile page).
3. Submit a monthly listing of locations (URLs) with real-time
discussion.
15
30-day submissions
Publicly accessible discussions
> Submit a list of URLs where real-time discussions are happening
> Update the list every 30 days (confirming, adding, or removing as
necessary) to reflect current involvement
> Do NOT submit the actual interactions themselves
Not publicly accessible discussions (e.g., behind a log-in)
> Submit a list of URLs where real-time discussions are happening
> Update the list every 30 days (confirming, adding, or removing as
necessary) to reflect current involvement
> Submit screenshots or other representations of the actual interactions
themselves
> Indicate what discussion sponsor owns
> Provide enough context for FDA to understand/evaluate the discussion
16
Open questions
1. What constitutes being publicly accessible?
a) If you have to “like” a page to view it, is it publicly
accessible?
2. Does this open up or limit the activities of
employees?
a) Do companies now have to submit the URL of every
employee who mentions a product on their Twitter,
Facebook, Tumblr, Pinterest, etc.?
3. Are companies responsible for sites where they
advertise?
Questions?
Dale Cooke
Vice President/Group Director, Regulatory
Dale.Cooke@DigitasHealth.com
@PhillyCooke on Twitter
www.scribd.com/Dale_Cooke
18
Dale Cooke
VP/Group Director, Regulatory
Dale Cooke is the head of the regulatory department for Digitas Health. He
has worked with more than 30 pharmaceutical and medical device clients and
with Medical-Legal-Regulatory committees around the world from offices in
Philadelphia, New York, Boston, San Francisco, and London. Dale advises
clients on FDA enforcement actions and provides recommendations for
compliance with FDA regulations, with a focus on issues involving the Internet
and emerging technology. His insights have been featured in the Wall Street
Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others.
Dale is an active member of the Regulatory Affairs Professionals Society
(RAPS), Drug Information Association (DIA), Alliance for a Stronger FDA, and
the Food and Drug Law Institute (FDLI).
Dale is the author of Effective Review and Approval of Digital Promotional
Tactics, which is part of the FDLI primer series. He is regularly invited to speak
at industry conferences on topics including FDA enforcement trends, best
practices for review processes, global review practices, and pharmaceutical
involvement in social media.
Dale earned his B.A. in Philosophy from Southern Methodist University, an
M.A. in Analytical Philosophy from the University of Arizona, and studied
Epidemiology and Biostatistics at Drexel University’s School of Public Health.

Mais conteúdo relacionado

Mais procurados

DIA Webinar Regulating a Social World
DIA Webinar Regulating a Social WorldDIA Webinar Regulating a Social World
DIA Webinar Regulating a Social WorldDale Cooke
 
Electronic Review Systems
Electronic Review SystemsElectronic Review Systems
Electronic Review SystemsDale Cooke
 
The Move to Mobile
The Move to MobileThe Move to Mobile
The Move to MobileDale Cooke
 
Regulatory Considerations in Mobile Programs
Regulatory Considerations in Mobile ProgramsRegulatory Considerations in Mobile Programs
Regulatory Considerations in Mobile ProgramsDale Cooke
 
DIA Marketing Pharmaceuticals 2015 Leveraging Innovative Technologies
DIA Marketing Pharmaceuticals 2015 Leveraging Innovative TechnologiesDIA Marketing Pharmaceuticals 2015 Leveraging Innovative Technologies
DIA Marketing Pharmaceuticals 2015 Leveraging Innovative TechnologiesDale Cooke
 
Mit wiroon dtpss_module 4_google health and ms health_vault launch (wiroon)
Mit wiroon dtpss_module 4_google health and ms health_vault launch (wiroon)Mit wiroon dtpss_module 4_google health and ms health_vault launch (wiroon)
Mit wiroon dtpss_module 4_google health and ms health_vault launch (wiroon)Enrique Mesones
 
Mit anonymous dtpss_module 4_google health and microsoft health_vault launch (4)
Mit anonymous dtpss_module 4_google health and microsoft health_vault launch (4)Mit anonymous dtpss_module 4_google health and microsoft health_vault launch (4)
Mit anonymous dtpss_module 4_google health and microsoft health_vault launch (4)Enrique Mesones
 
Mit dtpss module 4_google health and microsoft health_vault launch
Mit dtpss module 4_google health and microsoft health_vault launchMit dtpss module 4_google health and microsoft health_vault launch
Mit dtpss module 4_google health and microsoft health_vault launchEnrique Mesones
 
Dii POV: FDA Off-Label Guidance
Dii POV: FDA Off-Label GuidanceDii POV: FDA Off-Label Guidance
Dii POV: FDA Off-Label GuidanceRTC
 
The Impact and Use of Social Media in Pharmacovigilance
The Impact and Use of Social Media in PharmacovigilanceThe Impact and Use of Social Media in Pharmacovigilance
The Impact and Use of Social Media in PharmacovigilanceCovance
 
Protecting Health Data_FINAL3
Protecting Health Data_FINAL3Protecting Health Data_FINAL3
Protecting Health Data_FINAL3Paul Petronelli
 
Enterprise Content Management for Regulatory Compliance in Healthcare and Cre...
Enterprise Content Management for Regulatory Compliance in Healthcare and Cre...Enterprise Content Management for Regulatory Compliance in Healthcare and Cre...
Enterprise Content Management for Regulatory Compliance in Healthcare and Cre...Kishore Jethanandani, MBA, MA, MPhil,
 
Importance of social media in Pharmaceutical industry
Importance of social media in Pharmaceutical industryImportance of social media in Pharmaceutical industry
Importance of social media in Pharmaceutical industryActiance, Inc.
 
The impact of social media on the pharmaceutical sector
The impact of social media on the pharmaceutical sectorThe impact of social media on the pharmaceutical sector
The impact of social media on the pharmaceutical sectorPaul Grant
 
Integrating Social Media into Healthcare Systems Practice
Integrating Social Media into Healthcare Systems PracticeIntegrating Social Media into Healthcare Systems Practice
Integrating Social Media into Healthcare Systems PracticeMike Moore
 

Mais procurados (17)

DIA Webinar Regulating a Social World
DIA Webinar Regulating a Social WorldDIA Webinar Regulating a Social World
DIA Webinar Regulating a Social World
 
Electronic Review Systems
Electronic Review SystemsElectronic Review Systems
Electronic Review Systems
 
The Move to Mobile
The Move to MobileThe Move to Mobile
The Move to Mobile
 
Regulatory Considerations in Mobile Programs
Regulatory Considerations in Mobile ProgramsRegulatory Considerations in Mobile Programs
Regulatory Considerations in Mobile Programs
 
DIA Marketing Pharmaceuticals 2015 Leveraging Innovative Technologies
DIA Marketing Pharmaceuticals 2015 Leveraging Innovative TechnologiesDIA Marketing Pharmaceuticals 2015 Leveraging Innovative Technologies
DIA Marketing Pharmaceuticals 2015 Leveraging Innovative Technologies
 
Mit wiroon dtpss_module 4_google health and ms health_vault launch (wiroon)
Mit wiroon dtpss_module 4_google health and ms health_vault launch (wiroon)Mit wiroon dtpss_module 4_google health and ms health_vault launch (wiroon)
Mit wiroon dtpss_module 4_google health and ms health_vault launch (wiroon)
 
Mit anonymous dtpss_module 4_google health and microsoft health_vault launch (4)
Mit anonymous dtpss_module 4_google health and microsoft health_vault launch (4)Mit anonymous dtpss_module 4_google health and microsoft health_vault launch (4)
Mit anonymous dtpss_module 4_google health and microsoft health_vault launch (4)
 
Mit dtpss module 4_google health and microsoft health_vault launch
Mit dtpss module 4_google health and microsoft health_vault launchMit dtpss module 4_google health and microsoft health_vault launch
Mit dtpss module 4_google health and microsoft health_vault launch
 
Dii POV: FDA Off-Label Guidance
Dii POV: FDA Off-Label GuidanceDii POV: FDA Off-Label Guidance
Dii POV: FDA Off-Label Guidance
 
The Impact and Use of Social Media in Pharmacovigilance
The Impact and Use of Social Media in PharmacovigilanceThe Impact and Use of Social Media in Pharmacovigilance
The Impact and Use of Social Media in Pharmacovigilance
 
Protecting Health Data_FINAL3
Protecting Health Data_FINAL3Protecting Health Data_FINAL3
Protecting Health Data_FINAL3
 
Institution Bulletin: Volume 4 Issue 2
Institution Bulletin: Volume 4 Issue 2Institution Bulletin: Volume 4 Issue 2
Institution Bulletin: Volume 4 Issue 2
 
Enterprise Content Management for Regulatory Compliance in Healthcare and Cre...
Enterprise Content Management for Regulatory Compliance in Healthcare and Cre...Enterprise Content Management for Regulatory Compliance in Healthcare and Cre...
Enterprise Content Management for Regulatory Compliance in Healthcare and Cre...
 
Importance of social media in Pharmaceutical industry
Importance of social media in Pharmaceutical industryImportance of social media in Pharmaceutical industry
Importance of social media in Pharmaceutical industry
 
The impact of social media on the pharmaceutical sector
The impact of social media on the pharmaceutical sectorThe impact of social media on the pharmaceutical sector
The impact of social media on the pharmaceutical sector
 
Integrating Social Media into Healthcare Systems Practice
Integrating Social Media into Healthcare Systems PracticeIntegrating Social Media into Healthcare Systems Practice
Integrating Social Media into Healthcare Systems Practice
 
PS160718
PS160718PS160718
PS160718
 

Semelhante a Staying Compliant in a Social World

Internet Issues for FDA-Regulated Industry – A Review of Issues Involving Soc...
Internet Issues for FDA-Regulated Industry – A Review of Issues Involving Soc...Internet Issues for FDA-Regulated Industry – A Review of Issues Involving Soc...
Internet Issues for FDA-Regulated Industry – A Review of Issues Involving Soc...Michael Swit
 
New FDA Social Media Guidelines 2014: Star Group Analysis
New FDA Social Media Guidelines 2014: Star Group AnalysisNew FDA Social Media Guidelines 2014: Star Group Analysis
New FDA Social Media Guidelines 2014: Star Group AnalysisJoshua Spiegel
 
Social Media Guidelines and Safeguards for the Phamaceutical Industry: What Y...
Social Media Guidelines and Safeguards for the Phamaceutical Industry: What Y...Social Media Guidelines and Safeguards for the Phamaceutical Industry: What Y...
Social Media Guidelines and Safeguards for the Phamaceutical Industry: What Y...Stacy Lukasavitz Steele
 
FDA Regulation of Social Media and the Internet
FDA Regulation of Social Media and the InternetFDA Regulation of Social Media and the Internet
FDA Regulation of Social Media and the InternetMichael Swit
 
Getting To Yes! SXSW 2016 Panel Pick ...and winner!
Getting To Yes! SXSW 2016 Panel Pick ...and winner!Getting To Yes! SXSW 2016 Panel Pick ...and winner!
Getting To Yes! SXSW 2016 Panel Pick ...and winner!GettingToYesSXSW2015
 
PRSA Presentation
PRSA PresentationPRSA Presentation
PRSA PresentationRaidious
 
Slide Notes From CCC Presentation At Zinc Forum - PRT Efficiency - Turbo-Char...
Slide Notes From CCC Presentation At Zinc Forum - PRT Efficiency - Turbo-Char...Slide Notes From CCC Presentation At Zinc Forum - PRT Efficiency - Turbo-Char...
Slide Notes From CCC Presentation At Zinc Forum - PRT Efficiency - Turbo-Char...Center for Communication Compliance
 
FDA Regulation of Promotion & Advertising -- Social Media & Internet
FDA Regulation of Promotion & Advertising -- Social Media & InternetFDA Regulation of Promotion & Advertising -- Social Media & Internet
FDA Regulation of Promotion & Advertising -- Social Media & InternetMichael Swit
 
Fda issues guidance on reporting requirements for web based promotion of drug...
Fda issues guidance on reporting requirements for web based promotion of drug...Fda issues guidance on reporting requirements for web based promotion of drug...
Fda issues guidance on reporting requirements for web based promotion of drug...Market iT
 
FDA’s Draft Guidance – Exploring the impact on compliance and operations
FDA’s Draft Guidance – Exploring the impact on compliance and operationsFDA’s Draft Guidance – Exploring the impact on compliance and operations
FDA’s Draft Guidance – Exploring the impact on compliance and operationsHuron Consulting Group
 
Deal with (LACK) of Regulations, Develop Best Practices
Deal with (LACK) of Regulations, Develop Best PracticesDeal with (LACK) of Regulations, Develop Best Practices
Deal with (LACK) of Regulations, Develop Best PracticesPharma Guy
 
Social Media: UK FCA Guidance Consultation Summary & Opinion
Social Media: UK FCA Guidance Consultation Summary & OpinionSocial Media: UK FCA Guidance Consultation Summary & Opinion
Social Media: UK FCA Guidance Consultation Summary & OpinionDominic Crosthwaite
 
Social Media Ethical Use for Finance & Insurance
Social Media Ethical Use for Finance & InsuranceSocial Media Ethical Use for Finance & Insurance
Social Media Ethical Use for Finance & InsuranceDeborah Gonzalez, Esq.
 
Sabrena Sally 2010 Fowler Seminar
Sabrena Sally 2010 Fowler SeminarSabrena Sally 2010 Fowler Seminar
Sabrena Sally 2010 Fowler SeminarDon Grauel
 
Social Media & Investor Relations: It’s NOT Oil and Water
Social Media & Investor Relations: It’s NOT Oil and WaterSocial Media & Investor Relations: It’s NOT Oil and Water
Social Media & Investor Relations: It’s NOT Oil and WaterMichael Pranikoff
 
The SRA, The Law Society and Social Media
The SRA, The Law Society and Social MediaThe SRA, The Law Society and Social Media
The SRA, The Law Society and Social MediaBusiness Tendrils Ltd
 
Staying ahead of the curve social media compliance 10-7-2010 - final
Staying ahead of the curve   social media compliance 10-7-2010 - finalStaying ahead of the curve   social media compliance 10-7-2010 - final
Staying ahead of the curve social media compliance 10-7-2010 - finalDeborah Well
 

Semelhante a Staying Compliant in a Social World (20)

FDA Draft Social Guidance
FDA Draft Social GuidanceFDA Draft Social Guidance
FDA Draft Social Guidance
 
Internet Issues for FDA-Regulated Industry – A Review of Issues Involving Soc...
Internet Issues for FDA-Regulated Industry – A Review of Issues Involving Soc...Internet Issues for FDA-Regulated Industry – A Review of Issues Involving Soc...
Internet Issues for FDA-Regulated Industry – A Review of Issues Involving Soc...
 
New FDA Social Media Guidelines 2014: Star Group Analysis
New FDA Social Media Guidelines 2014: Star Group AnalysisNew FDA Social Media Guidelines 2014: Star Group Analysis
New FDA Social Media Guidelines 2014: Star Group Analysis
 
Social Media Guidelines and Safeguards for the Phamaceutical Industry: What Y...
Social Media Guidelines and Safeguards for the Phamaceutical Industry: What Y...Social Media Guidelines and Safeguards for the Phamaceutical Industry: What Y...
Social Media Guidelines and Safeguards for the Phamaceutical Industry: What Y...
 
FDA Regulation of Social Media and the Internet
FDA Regulation of Social Media and the InternetFDA Regulation of Social Media and the Internet
FDA Regulation of Social Media and the Internet
 
Getting To Yes! SXSW 2016 Panel Pick ...and winner!
Getting To Yes! SXSW 2016 Panel Pick ...and winner!Getting To Yes! SXSW 2016 Panel Pick ...and winner!
Getting To Yes! SXSW 2016 Panel Pick ...and winner!
 
WOMMA Ethics Committee White Paper (2014)
WOMMA Ethics Committee White Paper (2014)WOMMA Ethics Committee White Paper (2014)
WOMMA Ethics Committee White Paper (2014)
 
FDA Presentation: How Pharma Marketers Should Use Social Media
FDA Presentation: How Pharma Marketers Should Use Social MediaFDA Presentation: How Pharma Marketers Should Use Social Media
FDA Presentation: How Pharma Marketers Should Use Social Media
 
PRSA Presentation
PRSA PresentationPRSA Presentation
PRSA Presentation
 
Slide Notes From CCC Presentation At Zinc Forum - PRT Efficiency - Turbo-Char...
Slide Notes From CCC Presentation At Zinc Forum - PRT Efficiency - Turbo-Char...Slide Notes From CCC Presentation At Zinc Forum - PRT Efficiency - Turbo-Char...
Slide Notes From CCC Presentation At Zinc Forum - PRT Efficiency - Turbo-Char...
 
FDA Regulation of Promotion & Advertising -- Social Media & Internet
FDA Regulation of Promotion & Advertising -- Social Media & InternetFDA Regulation of Promotion & Advertising -- Social Media & Internet
FDA Regulation of Promotion & Advertising -- Social Media & Internet
 
Fda issues guidance on reporting requirements for web based promotion of drug...
Fda issues guidance on reporting requirements for web based promotion of drug...Fda issues guidance on reporting requirements for web based promotion of drug...
Fda issues guidance on reporting requirements for web based promotion of drug...
 
FDA’s Draft Guidance – Exploring the impact on compliance and operations
FDA’s Draft Guidance – Exploring the impact on compliance and operationsFDA’s Draft Guidance – Exploring the impact on compliance and operations
FDA’s Draft Guidance – Exploring the impact on compliance and operations
 
Deal with (LACK) of Regulations, Develop Best Practices
Deal with (LACK) of Regulations, Develop Best PracticesDeal with (LACK) of Regulations, Develop Best Practices
Deal with (LACK) of Regulations, Develop Best Practices
 
Social Media: UK FCA Guidance Consultation Summary & Opinion
Social Media: UK FCA Guidance Consultation Summary & OpinionSocial Media: UK FCA Guidance Consultation Summary & Opinion
Social Media: UK FCA Guidance Consultation Summary & Opinion
 
Social Media Ethical Use for Finance & Insurance
Social Media Ethical Use for Finance & InsuranceSocial Media Ethical Use for Finance & Insurance
Social Media Ethical Use for Finance & Insurance
 
Sabrena Sally 2010 Fowler Seminar
Sabrena Sally 2010 Fowler SeminarSabrena Sally 2010 Fowler Seminar
Sabrena Sally 2010 Fowler Seminar
 
Social Media & Investor Relations: It’s NOT Oil and Water
Social Media & Investor Relations: It’s NOT Oil and WaterSocial Media & Investor Relations: It’s NOT Oil and Water
Social Media & Investor Relations: It’s NOT Oil and Water
 
The SRA, The Law Society and Social Media
The SRA, The Law Society and Social MediaThe SRA, The Law Society and Social Media
The SRA, The Law Society and Social Media
 
Staying ahead of the curve social media compliance 10-7-2010 - final
Staying ahead of the curve   social media compliance 10-7-2010 - finalStaying ahead of the curve   social media compliance 10-7-2010 - final
Staying ahead of the curve social media compliance 10-7-2010 - final
 

Último

Identifying Signs of Mental Health Presentation (1).pptx
Identifying Signs of Mental Health Presentation (1).pptxIdentifying Signs of Mental Health Presentation (1).pptx
Identifying Signs of Mental Health Presentation (1).pptxsandhulove46637
 
Assisted Living Care Residency - PapayaCare
Assisted Living Care Residency - PapayaCareAssisted Living Care Residency - PapayaCare
Assisted Living Care Residency - PapayaCareratilalthakkar704
 
21 NEMT Trends & Statistics to Know in 2024
21 NEMT Trends & Statistics to Know in 202421 NEMT Trends & Statistics to Know in 2024
21 NEMT Trends & Statistics to Know in 2024Traumasoft LLC
 
Introduction to Evaluation and Skin Benefits
Introduction to Evaluation and Skin BenefitsIntroduction to Evaluation and Skin Benefits
Introduction to Evaluation and Skin Benefitssahilgabhane29
 
Three Keys to a Successful Margin: Charges, Costs, and Labor
Three Keys to a Successful Margin: Charges, Costs, and LaborThree Keys to a Successful Margin: Charges, Costs, and Labor
Three Keys to a Successful Margin: Charges, Costs, and LaborHealth Catalyst
 
Living Well Every Day: Lyons Wellness Practice | Nurtures Your Complete Health
Living Well Every Day: Lyons Wellness Practice | Nurtures Your Complete HealthLiving Well Every Day: Lyons Wellness Practice | Nurtures Your Complete Health
Living Well Every Day: Lyons Wellness Practice | Nurtures Your Complete HealthLyons Health
 
NEONATAL RESPIRATORY CARE FROM A PHYSIO POV.pptx
NEONATAL RESPIRATORY CARE FROM A PHYSIO POV.pptxNEONATAL RESPIRATORY CARE FROM A PHYSIO POV.pptx
NEONATAL RESPIRATORY CARE FROM A PHYSIO POV.pptxHanineHassan2
 
Basics of Giant Cell Tumor of bone (GCTB)
Basics of Giant Cell Tumor of bone (GCTB)Basics of Giant Cell Tumor of bone (GCTB)
Basics of Giant Cell Tumor of bone (GCTB)bishwabandhuniraula
 
Artificial Intelligence in Healthcare: Challenges, Risks, Benefits
Artificial Intelligence in Healthcare: Challenges, Risks, BenefitsArtificial Intelligence in Healthcare: Challenges, Risks, Benefits
Artificial Intelligence in Healthcare: Challenges, Risks, BenefitsIris Thiele Isip-Tan
 
ARTHRITIS.pptx Prepared by monika gopal Tutor
ARTHRITIS.pptx Prepared  by monika gopal TutorARTHRITIS.pptx Prepared  by monika gopal Tutor
ARTHRITIS.pptx Prepared by monika gopal TutorNehaKewat
 
CECT NECK NECK ANGIOGRAPHY CAROTID ANGIOGRAPHY
CECT NECK NECK ANGIOGRAPHY CAROTID ANGIOGRAPHYCECT NECK NECK ANGIOGRAPHY CAROTID ANGIOGRAPHY
CECT NECK NECK ANGIOGRAPHY CAROTID ANGIOGRAPHYRMC
 
Anatomy Shelf Notevbhhhhhhhhhhhhhhhs.pdf
Anatomy Shelf Notevbhhhhhhhhhhhhhhhs.pdfAnatomy Shelf Notevbhhhhhhhhhhhhhhhs.pdf
Anatomy Shelf Notevbhhhhhhhhhhhhhhhs.pdfhezamzaki1
 
Empathy Is a Stress Response - Choose Compassion instead
Empathy Is a Stress Response - Choose Compassion insteadEmpathy Is a Stress Response - Choose Compassion instead
Empathy Is a Stress Response - Choose Compassion insteadAlex Clapson
 
ACCA Version of AI & Healthcare: An Overview for the Curious
ACCA Version of AI & Healthcare: An Overview for the CuriousACCA Version of AI & Healthcare: An Overview for the Curious
ACCA Version of AI & Healthcare: An Overview for the CuriousKR_Barker
 
EYE CANCER.pptx prepared by Neha kewat digital learning
EYE CANCER.pptx prepared by  Neha kewat digital learningEYE CANCER.pptx prepared by  Neha kewat digital learning
EYE CANCER.pptx prepared by Neha kewat digital learningNehaKewat
 
Understanding Warts and Moles: Differences, Types, and Common Locations
Understanding Warts and Moles: Differences, Types, and Common LocationsUnderstanding Warts and Moles: Differences, Types, and Common Locations
Understanding Warts and Moles: Differences, Types, and Common LocationsNeha Sharma
 
Artificial Intelligence: Diabetes Management
Artificial Intelligence: Diabetes ManagementArtificial Intelligence: Diabetes Management
Artificial Intelligence: Diabetes ManagementIris Thiele Isip-Tan
 

Último (20)

Identifying Signs of Mental Health Presentation (1).pptx
Identifying Signs of Mental Health Presentation (1).pptxIdentifying Signs of Mental Health Presentation (1).pptx
Identifying Signs of Mental Health Presentation (1).pptx
 
Assisted Living Care Residency - PapayaCare
Assisted Living Care Residency - PapayaCareAssisted Living Care Residency - PapayaCare
Assisted Living Care Residency - PapayaCare
 
21 NEMT Trends & Statistics to Know in 2024
21 NEMT Trends & Statistics to Know in 202421 NEMT Trends & Statistics to Know in 2024
21 NEMT Trends & Statistics to Know in 2024
 
Introduction to Evaluation and Skin Benefits
Introduction to Evaluation and Skin BenefitsIntroduction to Evaluation and Skin Benefits
Introduction to Evaluation and Skin Benefits
 
Three Keys to a Successful Margin: Charges, Costs, and Labor
Three Keys to a Successful Margin: Charges, Costs, and LaborThree Keys to a Successful Margin: Charges, Costs, and Labor
Three Keys to a Successful Margin: Charges, Costs, and Labor
 
Living Well Every Day: Lyons Wellness Practice | Nurtures Your Complete Health
Living Well Every Day: Lyons Wellness Practice | Nurtures Your Complete HealthLiving Well Every Day: Lyons Wellness Practice | Nurtures Your Complete Health
Living Well Every Day: Lyons Wellness Practice | Nurtures Your Complete Health
 
NEONATAL RESPIRATORY CARE FROM A PHYSIO POV.pptx
NEONATAL RESPIRATORY CARE FROM A PHYSIO POV.pptxNEONATAL RESPIRATORY CARE FROM A PHYSIO POV.pptx
NEONATAL RESPIRATORY CARE FROM A PHYSIO POV.pptx
 
Basics of Giant Cell Tumor of bone (GCTB)
Basics of Giant Cell Tumor of bone (GCTB)Basics of Giant Cell Tumor of bone (GCTB)
Basics of Giant Cell Tumor of bone (GCTB)
 
Artificial Intelligence in Healthcare: Challenges, Risks, Benefits
Artificial Intelligence in Healthcare: Challenges, Risks, BenefitsArtificial Intelligence in Healthcare: Challenges, Risks, Benefits
Artificial Intelligence in Healthcare: Challenges, Risks, Benefits
 
ARTHRITIS.pptx Prepared by monika gopal Tutor
ARTHRITIS.pptx Prepared  by monika gopal TutorARTHRITIS.pptx Prepared  by monika gopal Tutor
ARTHRITIS.pptx Prepared by monika gopal Tutor
 
Painting Rats White Angers Them to No End
Painting Rats White Angers Them to No EndPainting Rats White Angers Them to No End
Painting Rats White Angers Them to No End
 
Annual Training
Annual TrainingAnnual Training
Annual Training
 
CECT NECK NECK ANGIOGRAPHY CAROTID ANGIOGRAPHY
CECT NECK NECK ANGIOGRAPHY CAROTID ANGIOGRAPHYCECT NECK NECK ANGIOGRAPHY CAROTID ANGIOGRAPHY
CECT NECK NECK ANGIOGRAPHY CAROTID ANGIOGRAPHY
 
Anatomy Shelf Notevbhhhhhhhhhhhhhhhs.pdf
Anatomy Shelf Notevbhhhhhhhhhhhhhhhs.pdfAnatomy Shelf Notevbhhhhhhhhhhhhhhhs.pdf
Anatomy Shelf Notevbhhhhhhhhhhhhhhhs.pdf
 
Empathy Is a Stress Response - Choose Compassion instead
Empathy Is a Stress Response - Choose Compassion insteadEmpathy Is a Stress Response - Choose Compassion instead
Empathy Is a Stress Response - Choose Compassion instead
 
SCOPE OF CRITICAL CARE ORGANIZATION
SCOPE OF CRITICAL CARE ORGANIZATIONSCOPE OF CRITICAL CARE ORGANIZATION
SCOPE OF CRITICAL CARE ORGANIZATION
 
ACCA Version of AI & Healthcare: An Overview for the Curious
ACCA Version of AI & Healthcare: An Overview for the CuriousACCA Version of AI & Healthcare: An Overview for the Curious
ACCA Version of AI & Healthcare: An Overview for the Curious
 
EYE CANCER.pptx prepared by Neha kewat digital learning
EYE CANCER.pptx prepared by  Neha kewat digital learningEYE CANCER.pptx prepared by  Neha kewat digital learning
EYE CANCER.pptx prepared by Neha kewat digital learning
 
Understanding Warts and Moles: Differences, Types, and Common Locations
Understanding Warts and Moles: Differences, Types, and Common LocationsUnderstanding Warts and Moles: Differences, Types, and Common Locations
Understanding Warts and Moles: Differences, Types, and Common Locations
 
Artificial Intelligence: Diabetes Management
Artificial Intelligence: Diabetes ManagementArtificial Intelligence: Diabetes Management
Artificial Intelligence: Diabetes Management
 

Staying Compliant in a Social World

  • 1. Staying Compliant in a Social World Presented by Dale Cooke
  • 2. 2 The 14 letters from 2009
  • 3. 3 Nov ’09 Part 15 Hearings & FDASIA Five questions: > What online communications are sponsors responsible for? > How can sponsors fulfill regulatory obligations in social media (2253 filings, fair balance, etc.)? > What should sponsors do about corrective messaging? > When are links appropriate? > How should sponsors deal with AERs? FDASIA mandate to produce guidance by July 2014
  • 4. 4 Social media guidance is here http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM 381352.pdf See also, http://www.scribd.com/doc/199434412/DH-Regulatory-Alert-2253-Filing-Requirements- for-Social-Media Released January 2014
  • 5. 5 Nov ’09 Part 15 Hearings & FDASIA Five questions: > What online communications are sponsors responsible for? > How can sponsors fulfill regulatory obligations in social media (2253 filings, fair balance, etc.)? > What should sponsors do about corrective messaging? > When are links appropriate? > How should sponsors deal with AERs? FDASIA mandate to produce guidance by July 2014
  • 7. 7 What is a guidance? “Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.” - From the FDA website
  • 9. 9 What are postmarketing submissions? All promotional materials must be submitted to FDA at the time of initial dissemination (i.e., the 2253 submission). This guidance addresses two questions about the 2253 submission: 1. Whether to submit materials 2. What to submit
  • 10. 10 User-generated content “a firm generally is not responsible for UGC that is truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular)”* * Postmarketing Guidance, page 5.
  • 11. 11 Determining whether to submit Three sets of circumstances: 1. Sites “owned, controlled, created, influenced, or operated by, or on behalf of the firm…. even if the influence is limited.”* 2. Site pages if the firm “influenced the placement” of promotional materials.** 3. When agents or employees are “acting on behalf of the firm”** * Postmarketing Guidance, page 3. ** Postmarketing Guidance, page 4.
  • 12. 12 Enforcement discretion “If a firm submits interactive promotional media in the manner described in this draft guidance, FDA intends to exercise enforcement discretion regarding the regulatory requirements for postmarketing submissions related to promotional labeling and advertising.”* Enforcement discretion means: 1. FDA has the legal authority to enforce legal and regulatory requirements in that area. 2. FDA will not use that authority. * Postmarketing Guidance, page 5.
  • 13. 13 Applying discretion to social media Firms have a legal obligation to submit all parts of a conversation prior to using them, but FDA will not take enforcement action against companies that fail to do so, IF THEY ABIDE BY THIS GUIDANCE.
  • 14. 14 What to submit 1. For static materials with interactive components, submit static and indicate what changes (e.g., which portion of the website houses an online discussion forum) 2. For third-party sites, submit static elements with first communication (e.g., first Tweet & Twitter profile page). 3. Submit a monthly listing of locations (URLs) with real-time discussion.
  • 15. 15 30-day submissions Publicly accessible discussions > Submit a list of URLs where real-time discussions are happening > Update the list every 30 days (confirming, adding, or removing as necessary) to reflect current involvement > Do NOT submit the actual interactions themselves Not publicly accessible discussions (e.g., behind a log-in) > Submit a list of URLs where real-time discussions are happening > Update the list every 30 days (confirming, adding, or removing as necessary) to reflect current involvement > Submit screenshots or other representations of the actual interactions themselves > Indicate what discussion sponsor owns > Provide enough context for FDA to understand/evaluate the discussion
  • 16. 16 Open questions 1. What constitutes being publicly accessible? a) If you have to “like” a page to view it, is it publicly accessible? 2. Does this open up or limit the activities of employees? a) Do companies now have to submit the URL of every employee who mentions a product on their Twitter, Facebook, Tumblr, Pinterest, etc.? 3. Are companies responsible for sites where they advertise?
  • 17. Questions? Dale Cooke Vice President/Group Director, Regulatory Dale.Cooke@DigitasHealth.com @PhillyCooke on Twitter www.scribd.com/Dale_Cooke
  • 18. 18 Dale Cooke VP/Group Director, Regulatory Dale Cooke is the head of the regulatory department for Digitas Health. He has worked with more than 30 pharmaceutical and medical device clients and with Medical-Legal-Regulatory committees around the world from offices in Philadelphia, New York, Boston, San Francisco, and London. Dale advises clients on FDA enforcement actions and provides recommendations for compliance with FDA regulations, with a focus on issues involving the Internet and emerging technology. His insights have been featured in the Wall Street Journal’s Health blog, The Pink Sheet, MedAdNews, PharmExec, and others. Dale is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), Alliance for a Stronger FDA, and the Food and Drug Law Institute (FDLI). Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is part of the FDLI primer series. He is regularly invited to speak at industry conferences on topics including FDA enforcement trends, best practices for review processes, global review practices, and pharmaceutical involvement in social media. Dale earned his B.A. in Philosophy from Southern Methodist University, an M.A. in Analytical Philosophy from the University of Arizona, and studied Epidemiology and Biostatistics at Drexel University’s School of Public Health.