I presented this deck to the AdvaMed Advertising and Promotion of Medical Devices Conference on November 7, 2018.

1. Developing an Effective
Review Process for
Medical Device Promotion
Presented by:
Dale Cooke
PhillyCooke Consulting
DCooke@PhillyCooke.com
@PhillyCooke
November 7, 2018

2. PhillyCooke Consulting helps companies
communicate about FDA-regulated products
using 21st century tools, while remaining
compliant with regulations written in the 1960s.
PhillyCooke Consulting services focus on
1. Review & Approval Process Improvement
2. Training
3. Promotional Review of Tactics
4. Policy Development
5. Agency Submission Preparation

3. Disclosure: PhillyCooke Consulting is not a law
firm, and nothing provided in this presentation
should be construed as offering legal advice.
Specific details of each company’s promotional
efforts might require adjustments of the
information provided in this presentation.
Use of examples does not constitute
endorsement of the practices shown.

4. Topics
1.Why Review Ad-Promo
2.Review & Approval Process
3.Review Systems
4.Best Practices
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5. Why Review Ad-Promo?

6. Risk Mitigation
Promotional materials are public documents
viewed by multiple audiences, including:
‣ Competitors
‣ Plaintiff’s attorneys
‣ Department of Justice
‣ FDA
‣ Whistleblowers
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7. Risks from Promo Materials
‣ New intended uses/off-label promotion
‣ False claims act prosecutions
‣ Antikickback statute violations
‣ Product liability
‣ Claims substantiation
Plus traditional legal concerns
‣ Trademark
‣ Copyright
‣ FTC compliance
‣ Sweepstakes & contests
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8. Unique Challenges to the
Medical Device Industry
‣ No 2253 filing (don’t get the final samples)
‣ No expiry review (outdated materials still
being distributed)
‣ No tracking material release/expiry (literally
no idea what is being used)
‣ Homemade materials (especially from
contractors)
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9. 510(k) Modification Guidance
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10. Especially challenging materials
‣ Digital tactics
‣ Social media/engagement
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11. Review & Approval Process

12. Although there are laws about
the communications
themselves, there are no laws
or regulations about how
companies comply
with the regulations.
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13. Functions Don’t Vary
1. Concept Review
2. Med-Legal Review
3. Check Changes
4. Executive Committee Review
5. Final Samples
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14. Functions Don’t Vary
1. Concept Review
2. Med-Legal Review
3. Check Changes
4. Executive Committee Review
5. Final Samples
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15. The Final Step
The 2253 submission is itself a regulatory
requirement for all product promotions
‣ No product promotions
can be used prior to
submission on Form 2253
This does NOT apply to
medical devices or
disease awareness
communications
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16. It’s Finally Approved…
Until It’s Not
The quarantine/annual review
All materials have a sunset provision for their
use
Typically, that’s one year; sometimes two
years.
Six months if using the word “new.”
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17. Systems

18. The Enemy
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19. Review Systems Are Great
Benefits include
‣ Faster approval times
‣ Complete audit trail
‣ Lower agency costs
‣ Improved compliance
Drawbacks are real:
‣ Systems don’t fix process flaws
‣ Expensive
‣ Infrequent users are confused
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20. Essential Features
‣ Unique item number from promotional pieces
‣ Clear status indication (approved for use,
unapproved)
‣ Expiration date
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21. Best Practices

22. Determining Membership and
Ownership
‣ Legal
‣ Medical
‣ Regulatory
‣ Engineering
‣ Compliance
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23. Clearly Communicate Outcomes
There are only four possible outcomes of a
review
‣ Approved
‣ Approved with Changes
‣ Revise & Re-submit
‣ Rejected
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24. Expedited Reviews
‣ Emergencies justifying expedited review will
happen
‣ SOPs should accommodate the need for such
review
‣ Ideal procedure strikes a balance, neither too
easy nor too difficult
• For example, requiring signatures of Business Unit VP for
expedited reviews is something that can be done, but is
not likely to be abused because people don’t want to
repeatedly ask for the exception
‣ Track the number of expedited reviews
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25. Submissions Deadlines
‣ There should be a deadline for submitting
materials for review at an MLR meeting
‣ Reviewers should have time to review prior to
meetings
‣ Tuesday & Wednesday at noon are the magic
times to get the best work from agencies
‣ Re-reviews & check changes reviews should
require less advance submission time
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26. Approval to Use Message
‣ Clear definitive communication should occur
that materials may be used
‣ Electronic systems will auto-generate such a
message
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27. Measuring Performance
‣ Develop metrics that affect performance, not
that are easy to measure
‣ Evaluate performance of all parties (ad
agencies, brand managers, reviewers,
marketing ops)
‣ Distribute the evaluations regularly (monthly
or quarterly)
• Make ad agency performance public to all brand managers
and agencies
• Make brand manager, reviewer, and marketing ops
performance visible internally
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28. Sample Metric
Ad agency performance on MLR reviews
̶ Are materials submitted on time?
̶ Do materials contain spelling, grammar
mistakes?
̶ Was the medical referencing acceptable?
̶ Were all components included as required?
̶ Were any paperwork/submissions forms
completed correctly?
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29. Additional Process Points
‣ Add a formal chair to all meetings
‣ Conduct paperless reviews
‣ Providing a formal mark-up of changes
requested from every review
‣ Have a separate editor, reporting to
Regulatory Department
‣ Shift responsibility for the check changes to
the editor from the brand manager or
reviewers
‣ Multiple review streams for types of projects
(re-sizes vs. new content)
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30. Annual Reviews
‣ Few websites (or many other digital tactics) will
remain unchanged for a full year.
‣ Frequent updates to portions of these tactics
can result in full tactics failing to undergo typical
expiration/annual review
‣ To address this:
1. Establish an annual review date on first
submission of the tactic
2. Permit updates up to 90 days prior to the
expiration date
3. Any update within 90 days of the expiration
becomes the annual review !30

31. 2253 Filings
‣ Decisions about what to file and how have
regulatory implications
‣ Many enforcement actions include 2253
submissions failures
‣ Companywide policies are needed and must
be updated annually
• Submissions come from your company
‣ Recent FDA guidance provides good starting
point
Guidance for Industry: Providing Regulatory Submissions in Electronic and Non-Electronic Format—
Promotional Labeling and Advertising Materials for Human Prescription Drugs FDA 2015
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32. Executive Committee Role
‣ Frequently Executive Committees are used
solely to resolve disputes
‣ Can play a vital role in endorsing (or
correcting) decisions about new technology &
disseminating those decisions throughout the
company
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33. Questions?
Dale Cooke
PhillyCooke Consulting
DCooke@PhillyCooke.com
@PhillyCooke on Twitter
PhillyCooke.com
www.Scribd.com/Dale_Cooke
www.slideshare.net/PhillyCooke
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34. Dale Cooke
Dale Cooke is the president of PhillyCooke Consulting, which helps companies communicate
about FDA-regulated products using 21st century tools, while remaining compliant with regulations
written in the 1960s. Dale has worked with more than 50 pharmaceutical and medical device clients
and more than 20 advertising agencies around the world. His insights have been featured in the
Politico, The Pink Sheet, Stat News, Law360, and other publications. Dale is an active member of
the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), Food and
Drug Law Institute (FDLI), the Alliance for a Stronger FDA, and the Google Health Advisory Board.
Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is now in
its second edition in FDLI’s Topics in Food and Drug Law 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 life sciences use of social media. Previously, Dale served
as the head of Regulatory for Digitas Health LifeBrands, which is part of the Publicis Healthcare
Communications Group.
Dale earned his B.A. in Philosophy from Southern Methodist University, an M.A. in Philosophy from
the University of Arizona, and studied Epidemiology and Biostatistics at Drexel University’s School of
Public Health and Healthcare Compliance at Seton Hall University’s School of Law. Dale is
currently enrolled at Drexel University’s Kline School of Law with anticipated JD completion in 2019.
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