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©2010 Copyright
© 2015 ComplianceOnline
This training session is sponsored by
1
FDA Regulation of Promotion & Advertising
Part 8: Handling Promotional Compliance at the Company
Level
ComplianceOnline Seminar
November 6-7, 2014
Michael A. Swit, Esq.
LAW OFFICES OF MICHAEL A. SWIT
www.complianceonline.com
©2015 Copyright
Standard Disclaimers
➢ Views expressed here are solely mine and do not
reflect those of my law firm or any of its clients.
➢ This presentation supports an oral briefing and
should not be relied upon solely on its own to
support any conclusion of law or fact.
➢ This presentation, and the materials included
herewith, are provided for general educational
purposes and should not be construed as legal
advice.
2
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©2015 Copyright
➢ There is no right way on how to do this; have to
create a system that works for you company. But
any system should have, at minimum:
– Procedure
– Training
– Records
– Audits
– Validating
Keys to Implementing A System
3
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©2015 Copyright
Analyze Your Label
4
➢ Analyze your label in advance; prepare a template
– What are the key risk info?
– What is key about indications?
– What studies support what claims?
– What should go into a Brief Summary?
➢ Substantiate all statements of fact
– correlate to source materials
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©2015 Copyright
➢ Medical
➢ R&D/Clinical – they know what was done to
support
➢ Regulatory – they know what was approved
➢ Quality – for formal reslease
➢ Labeling Department
➢ Marketing
➢ Legal
➢ Compliance (if you have a separate function)
➢ Outside creative agencies
➢ One person – clearly should own the process
Have a Team
5
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©2015 Copyright
Miscellaneous issues
➢ How to handle and resolve comment
➢ Controlling sales reps
➢ Sign-off’s when using statements of third-parties
– e.g., clinicians, KOL’s
➢ Reprints – don’t forget copyright compliance
➢ Clinicians speaking on your behalf –
– training
– contract to follow your procedures (e.g., on off-label use)
➢ Record retention – establish system
6
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©2015 Copyright
Key Measures to Take to Protect
You and Your Company From Liability
7
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©2015 Copyright
How to Protect Yourself and Your Company
➢ COMPLY!!
– THE REST IS COMMENTARY …
– But …
8
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©2015 Copyright
➢ Implement an Effective Compliance Program
➢ Written Policies and Procedures
– Code of Conduct – on Business Ethics and Compliance
– Specific procedures for key aspects of operations – not just
those related to FDA compliance, but also:
• vendor contracts
• marketing
• pricing
• deals with doctors
• interactions with government officials, domestic and foreign
• reporting of compliance programs
What to Do to Protect/Mitigate Liability
9
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©2015 Copyright
➢ Compliance Officer and Committee – institute; with
authority to:
– Direct line report to CEO (not to CFO or G.C.) – must be able
to act independently and have access to Board of Directors
(e.g., if CEO is the bad doer)
– lead responsibility for compliance
– adequate resources & budget –
• side note – Warning Letter – signal to senior management to make
resources available to correct violations
➢ Communication – must be avenues within company
and to outside directors, if needed
What to Do to Protect/Mitigate Liability …
10
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©2015 Copyright
Three slides left …
11
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©2015 Copyright
➢ Training and education
– Reading is not enough
– Must be renewed periodically
• at Par, we retrained on the code of conduct annually
– Must be validated
➢ Auditing and Monitoring
– As with FDA operational audits, all compliance processes must
be audited
– Internal and external are recommended
– But, must act on what you find
What to Do to Protect/Mitigate Liability …
12
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©2015 Copyright
➢ Disciplining Offenses
– Have clear guidelines on discipline – up to and including
termination
– Enforce consistently and vigorously
➢ Responding to Detected Problems
– Do the “right” thing, promptly and comprehensively
– Investigate and correct (need a procedure for this as with
CAPA)
➢ Treat Your Employees Fairly – to minimize the
potential for whistleblowers; but remember you can’t
retaliate
What to Do to Protect/Mitigate Liability …
13
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©2015 Copyright
➢ P = Procedures
➢ T = Training
➢ V = Validation
➢ R = Records
➢ A = Audit
➢ C = Communications – Open Channels
➢ C = Compliance Culture from the Top
Final Sermon:
Please Teach Vigorous Risk Avoidance
Comprehensively and Corporately
14
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©2015 Copyright
No slides left …
15
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©2015 Copyright
End of Part 8:
Handling Promotional Compliance at the
Company Level
www.complianceonline.com
©2015 Copyright
Questions?
➢ Call or e-mail:
Michael A. Swit, Esq.
LAW OFFICES OF MICHAEL A. SWIT
San Diego, California
m: 760-815-4762
e: mswit@fdacounsel.com
web: www.fdacounsel.com
➢ Follow me on:
– LinkedIn: http://www.linkedin.com/in/michaelswit
– Twitter: https://twitter.com/FDACounsel
www.complianceonline.com
©2015 Copyright
About Your Speaker
Michael A. Swit, Esq., has been addressing critical FDA legal and regulatory issues
since 1984. Before returning to private law practice in late 2017, he served for 3 years
at Illumina, Inc. as Senior Director, Legal, Regulatory. Prior to that, Swit was a
special counsel at the global law firm of Duane Morris LLP in its San Diego
office. Before joining Duane Morris in March 2012, Swit served for seven years as a
vice president at The Weinberg Group Inc., a preeminent scientific and regulatory
consulting firm in the Life Sciences. His expertise includes product development,
compliance and enforcement, recalls and crisis management, submissions and
related traditional FDA regulatory activities, labeling and advertising, and clinical
research efforts for all types of life sciences companies, with a particular emphasis
on drugs, biologics and therapeutic biotech products. His FDA legal and regulatory
work also has included tenures in private practice with McKenna & Cuneo (now
Dentons) and Heller Ehrman, and as vice president, general counsel and secretary
of Par Pharmaceutical, a top public generic and specialty drug firm. He also was,
from 1994 to 1998, CEO of FDANews.com, a premier publisher of regulatory
newsletters and other specialty information products for FDA-regulated firms. He
has taught and written on many topics relating to FDA regulation and associated
commercial activities and is a past member of the Food & Drug Law Journal
Editorial Board. He earned his A.B., magna cum laude, with high honors in history,
at Bowdoin College, and his law degree at Emory University.

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FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Compliance at the Company Level

  • 1. www.complianceonlie.com ©2010 Copyright © 2015 ComplianceOnline This training session is sponsored by 1 FDA Regulation of Promotion & Advertising Part 8: Handling Promotional Compliance at the Company Level ComplianceOnline Seminar November 6-7, 2014 Michael A. Swit, Esq. LAW OFFICES OF MICHAEL A. SWIT
  • 2. www.complianceonline.com ©2015 Copyright Standard Disclaimers ➢ Views expressed here are solely mine and do not reflect those of my law firm or any of its clients. ➢ This presentation supports an oral briefing and should not be relied upon solely on its own to support any conclusion of law or fact. ➢ This presentation, and the materials included herewith, are provided for general educational purposes and should not be construed as legal advice. 2
  • 3. www.complianceonline.com ©2015 Copyright ➢ There is no right way on how to do this; have to create a system that works for you company. But any system should have, at minimum: – Procedure – Training – Records – Audits – Validating Keys to Implementing A System 3
  • 4. www.complianceonline.com ©2015 Copyright Analyze Your Label 4 ➢ Analyze your label in advance; prepare a template – What are the key risk info? – What is key about indications? – What studies support what claims? – What should go into a Brief Summary? ➢ Substantiate all statements of fact – correlate to source materials
  • 5. www.complianceonline.com ©2015 Copyright ➢ Medical ➢ R&D/Clinical – they know what was done to support ➢ Regulatory – they know what was approved ➢ Quality – for formal reslease ➢ Labeling Department ➢ Marketing ➢ Legal ➢ Compliance (if you have a separate function) ➢ Outside creative agencies ➢ One person – clearly should own the process Have a Team 5
  • 6. www.complianceonline.com ©2015 Copyright Miscellaneous issues ➢ How to handle and resolve comment ➢ Controlling sales reps ➢ Sign-off’s when using statements of third-parties – e.g., clinicians, KOL’s ➢ Reprints – don’t forget copyright compliance ➢ Clinicians speaking on your behalf – – training – contract to follow your procedures (e.g., on off-label use) ➢ Record retention – establish system 6
  • 7. www.complianceonline.com ©2015 Copyright Key Measures to Take to Protect You and Your Company From Liability 7
  • 8. www.complianceonline.com ©2015 Copyright How to Protect Yourself and Your Company ➢ COMPLY!! – THE REST IS COMMENTARY … – But … 8
  • 9. www.complianceonline.com ©2015 Copyright ➢ Implement an Effective Compliance Program ➢ Written Policies and Procedures – Code of Conduct – on Business Ethics and Compliance – Specific procedures for key aspects of operations – not just those related to FDA compliance, but also: • vendor contracts • marketing • pricing • deals with doctors • interactions with government officials, domestic and foreign • reporting of compliance programs What to Do to Protect/Mitigate Liability 9
  • 10. www.complianceonline.com ©2015 Copyright ➢ Compliance Officer and Committee – institute; with authority to: – Direct line report to CEO (not to CFO or G.C.) – must be able to act independently and have access to Board of Directors (e.g., if CEO is the bad doer) – lead responsibility for compliance – adequate resources & budget – • side note – Warning Letter – signal to senior management to make resources available to correct violations ➢ Communication – must be avenues within company and to outside directors, if needed What to Do to Protect/Mitigate Liability … 10
  • 12. www.complianceonline.com ©2015 Copyright ➢ Training and education – Reading is not enough – Must be renewed periodically • at Par, we retrained on the code of conduct annually – Must be validated ➢ Auditing and Monitoring – As with FDA operational audits, all compliance processes must be audited – Internal and external are recommended – But, must act on what you find What to Do to Protect/Mitigate Liability … 12
  • 13. www.complianceonline.com ©2015 Copyright ➢ Disciplining Offenses – Have clear guidelines on discipline – up to and including termination – Enforce consistently and vigorously ➢ Responding to Detected Problems – Do the “right” thing, promptly and comprehensively – Investigate and correct (need a procedure for this as with CAPA) ➢ Treat Your Employees Fairly – to minimize the potential for whistleblowers; but remember you can’t retaliate What to Do to Protect/Mitigate Liability … 13
  • 14. www.complianceonline.com ©2015 Copyright ➢ P = Procedures ➢ T = Training ➢ V = Validation ➢ R = Records ➢ A = Audit ➢ C = Communications – Open Channels ➢ C = Compliance Culture from the Top Final Sermon: Please Teach Vigorous Risk Avoidance Comprehensively and Corporately 14
  • 16. www.complianceonline.com ©2015 Copyright End of Part 8: Handling Promotional Compliance at the Company Level
  • 17. www.complianceonline.com ©2015 Copyright Questions? ➢ Call or e-mail: Michael A. Swit, Esq. LAW OFFICES OF MICHAEL A. SWIT San Diego, California m: 760-815-4762 e: mswit@fdacounsel.com web: www.fdacounsel.com ➢ Follow me on: – LinkedIn: http://www.linkedin.com/in/michaelswit – Twitter: https://twitter.com/FDACounsel
  • 18. www.complianceonline.com ©2015 Copyright About Your Speaker Michael A. Swit, Esq., has been addressing critical FDA legal and regulatory issues since 1984. Before returning to private law practice in late 2017, he served for 3 years at Illumina, Inc. as Senior Director, Legal, Regulatory. Prior to that, Swit was a special counsel at the global law firm of Duane Morris LLP in its San Diego office. Before joining Duane Morris in March 2012, Swit served for seven years as a vice president at The Weinberg Group Inc., a preeminent scientific and regulatory consulting firm in the Life Sciences. His expertise includes product development, compliance and enforcement, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for all types of life sciences companies, with a particular emphasis on drugs, biologics and therapeutic biotech products. His FDA legal and regulatory work also has included tenures in private practice with McKenna & Cuneo (now Dentons) and Heller Ehrman, and as vice president, general counsel and secretary of Par Pharmaceutical, a top public generic and specialty drug firm. He also was, from 1994 to 1998, CEO of FDANews.com, a premier publisher of regulatory newsletters and other specialty information products for FDA-regulated firms. He has taught and written on many topics relating to FDA regulation and associated commercial activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his A.B., magna cum laude, with high honors in history, at Bowdoin College, and his law degree at Emory University.