November 10, 2017 presentation to the ComplianceOnline course on Ensuring Compliance with FDA Regulation of Promotion & Advertising of Drugs and Medical Devices, in Boston.

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This training session is sponsored by
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FDA Regulation of Promotion & Advertising
Part 8: Handling Promotional Compliance at the Company
Level
ComplianceOnline Seminar
November 6-7, 2014
• Michael A. Swit, Esq.

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 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
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Analyze Your Label
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 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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 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
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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
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Key Measures to Take to Protect
You and Your Company From Liability
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How to Protect Yourself and Your Company
 COMPLY!!
– THE REST IS COMMENTARY …
– But …
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 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
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 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 …
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 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 …
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 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 …
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 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
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End of Part 8:
Handling Promotional Compliance at the
Company Level

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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

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About Your Speaker
Michael A. Swit, Esq., has been addressing critical FDA legal and regulatory issues
since 1984. Before returning to his 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 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.