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FDA Regulation of Advertising and Promotion -- Handling Promotional Compliance at the Company Level


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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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FDA Regulation of Advertising and Promotion -- Handling Promotional Compliance at the Company Level

  1. 1. ©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.
  2. 2. ©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 2
  3. 3. ©2015 Copyright Analyze Your Label 3  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
  4. 4. ©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 4
  5. 5. ©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 5
  6. 6. ©2015 Copyright Key Measures to Take to Protect You and Your Company From Liability 6
  7. 7. ©2015 Copyright How to Protect Yourself and Your Company  COMPLY!! – THE REST IS COMMENTARY … – But … 7
  8. 8. ©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 8
  9. 9. ©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 … 9
  10. 10. ©2015 Copyright Three slides left … 10
  11. 11. ©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 … 11
  12. 12. ©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 … 12
  13. 13. ©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 13
  14. 14. ©2015 Copyright No slides left … 14
  15. 15. ©2015 Copyright End of Part 8: Handling Promotional Compliance at the Company Level
  16. 16. ©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: web:  Follow me on: – LinkedIn: – Twitter:
  17. 17. ©2015 Copyright 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, 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.