Search engines are the gateway to the Internet for most people, and FDA has a lengthy history of taking enforcement against companies for inappropriate promotion of prescription drugs via this vital tactic. This presentation from DIA's 2021 ad-promo conference was updated with the latest enforcement.

1. Advertising and
Promotion Regulatory
Affairs Conference
March 8
Search Engine Marketing
& Optimization
Presented by:
Dale Cooke
President, PhillyCooke Consulting

2. The views and opinions expressed in the following PowerPoint slides are those
of the individual presenter and should not be attributed to DIA, its directors,
officers, employees, volunteers, members, chapters, councils, Communities or
affiliates, or any organization with which the presenter is employed or affiliated.
These PowerPoint slides are the intellectual property of the individual presenter
and are protected under the copyright laws of the United States of America and
other countries. Used by permission. All rights reserved. DIA and the DIA logo
are registered trademarks or trademarks of Drug Information Association Inc. All
other trademarks are the property of their respective owners.
Disclaimer
Page 2
© 2021 DIA, Inc. All rights reserved.

3. Not intended to be legal advice. Please talk to your attorney for
advice that may be right for you.
For educational purposes only
Legal Disclaimers
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4. Importance & Anatomy Paid Search
The Infamous 14 Letters
Post-2009 Google SEM Ads
2014 FDA Guidances
Vanity URLs and Platform Differences
Recent FDA Enforcement
Topics
4

5. More than 90% of Internet Users Rely on Search Engines
Google Dominates Search
• Reports of Google’s market share range from 62% to 92%
• Bing & Yahoo! (Verizon) are next biggest players
• Duck Duck Go, Ask, and others round out the field
Engine-specific Policies Are Relevant
Importance of Search
5

6. Home of the Internet--SERP
Home of the Internet: SERP
6

7. Search Engine Results Page
7
Paid Search (SEM) in red box
Organic search in blue box
Knowledge panel in green box

8. Anatomy of a Text Ad
8
Destination URL:
https://www.nexletol.com/
Headline
Display URL
Sitelinks
Description

9. Anatomy of a Text Ad
9
Keywords

10. The Infamous 14 Letters: April 2009
10

11. The Infamous 14 Letters: April 2009
11

12. Sample Violative Material
12

13. Sample Violative Material
13

14. 1.Disease Awareness Ads
2.Reminder Ads
3.Redirecting Ads
Post-2009 Acceptable Formats
14

15. ‣ Link to disease awareness campaigns
‣ Cannot mention products
‣ Cannot imply a specific product
‣ Cannot be combined with product reminder ads to
form a single message
When done correctly, FDA has no authority over
these
Disease Awareness Ads
15

16. 21 CFR 202.1(e)(2)(i), 201.100, 200.200
“Reminder advertisements are those which call
attention to the name of the drug product but do not
include indications or dosage recommendations for the
use of the drug product.”
No compliant reminder ad was cited in the 14 letters
Reminder Advertising
16

17. 1. Brand name (if applicable)*
2. Generic name and/or active ingredients*
3. Quantitative ingredient statements (e.g., 20 mg)
4. Dosage form (e.g., tablets, capsules)
5. Package contents (e.g., 30 tablets)
6. Price
7. Other information so long as it makes “no representation or suggestion” about the product
use
A. “FDA-approved”
B. Call to action devoid of product description
C. Universal features (e.g., PI, “Dosage”)
* Required
Reminder Ads
17

18. Redirecting Ads
18

19. ‣ Link to product sites
‣ Cannot mention products
‣ Cannot imply a specific product
‣ Cannot be combined with product reminder ads to
form a single message
When done correctly, FDA has no authority over
these
Redirecting Ads
19

20. FDA Guidance
20
Issued June 2014
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/internetsocial-media-platforms-character-space-limitations-presenting-risk-and-benefit-information-0

21. This guidance is limited to platforms and formats
that limit the number of characters available for a
message (e.g., microblogging & paid search)
The guidance does not include
‣ Mobile device promotion
‣ Reminder ads
‣ Reminder-like ads* for black box drugs
Scope of Guidance
21
* For more on reminder-like ads, see
http://regulatoryrx.blogspot.com/2014/10/reminder-like-promotions.html

22. May provide benefit & risk in space-limited contexts so long as message includes
• Brand name
• Generic name and/or active ingredients
• Non-misleading indication statement
• Abbreviated risk info (with ALL life-threatening risks)
• Link to
a.Full risk information
b.Dosage form
c.Quantitative ingredient information
d.Full label
To save space, sponsors may
1. Use scientific abbreviations
2. Use linguistic symbols (e.g., & instead of “and”)
3. Use punctuation instead of words (e.g., — to separate ideas)
FDA Recommendations
22

23. “If an accurate and balanced presentation of both
risks and benefits of a specific product is not possible
within the constraints of the platform, then the firm
should reconsider using that platform for the
intended promotional message (other than for
permitted reminder promotion).”
—page 5
Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations—
Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
If unable to meet these requirements…
23

24. FDA on Site Links
24
“FDA would not intend to object to
this sponsored link format for
Headhurtz”
—page 15
Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations—
Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

25. “Sitelink extensions take people to specific pages on
your site.”
—From Google Sitelink Description
https://support.google.com/google-ads/answer/2375416
Sitelinks
25

26. ‣ Sitelinks won’t always appear
‣ Sitelink descriptions will not appear on mobile
‣ Exact order of sitelinks might vary
Sitelink Limitations
26

27. FDA on Site Links
27
Balancing Risk
Information

28. FDA on Site Links
28
Balancing Risk
Information
The site link descriptions are NOT guaranteed to appear,
and will NOT appear on mobile!

29. Apply to drugs with black box warnings
1.Brand name (if applicable)*
2.Generic name and/or active ingredients*
3.“Please see…” statement*
4.Provision of PI or Brief Summary immediately
accompanying the advertisement*
* Required
Reminder-like Ads
29
For more on reminder-like ads, see
http://regulatoryrx.blogspot.com/2014/10/reminder-like-promotions.html
and
http://regulatoryrx.blogspot.com/2015/06/google-search-engine-marketing-changing.html

30. Sample Reminder-like Ad
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31. ‣ Option 1
‣ Option 2
‣ Google text options
Prescription treatment website
Prescription device website
Medical device website
Preventative treatment website
Prescription contraception website
Prescription vaccine website
Google Redirecting Ads: Vanity URLs
31
Sitio de tratamientos con receta
Sitio de dispositivos con receta
Sitio de dispositivos médicos
Sitio de tratamientos preventivos
Sitio de anticonceptivos con receta
Sitio de vacunas con receta

32. ‣ Prescription product marketers will still have complete control over the
destination URL (i.e., the link that people arrive at after clicking on the ad).
‣ CompanyName.com is a template. The actual display URL will be the
company’s name, not the words “CompanyName.”
‣ To use CompanyName.com, the display URL must be real and be live. So, if
you don’t own the URL that matches, you can’t use it. For example, if your
company’s URL is CompanyName-USA.com, then the display URL would
need to be “CompanyName-USA.com.”
‣ The Google text options are not templates. The actual words “Prescription
treatment website,” etc., will appear. Companies cannot alter them.
‣ This is a Google policy that does NOT affect Yahoo!, Bing, or others
Vanity URLs vs. Destination URL
32

33. Bing vs. Google Redirecting Ad Results
33

34. Recent FDA Enforcement
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35. Recent FDA Enforcement
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36. Must review all elements of the ad
Understand character-count and other limitations on different
elements for each search engine in use
Need to separate campaigns by type (reminder ads vs.
redirecting ads) and audience (HCP vs. Consumer)
Understand how the compaigns are tied together, e.g., which ads
will run simultaneously
Reviewing Search Ads
© 2020 DIA, Inc. All rights reserved. Page 36

37. Keywords are analogous to a media plan in traditional media
Need to review both positive and negative keywords
Should ensure that all keywords do not suggest an off-label use
Keywords themselves do NOT need to be submitted to the
Agency with the 2253 filing
Keyword Review
© 2020 DIA, Inc. All rights reserved. Page 37

38. Metadata: Computer coding that provides information for search
engines about the content on the page. Most metadata is never
seen by an end-user.
Metadescription: Brief summary of the webpage content that
MIGHT be shown in organic search results
Alt-text: Copy describing pictures on the webpage; assists in
optimizing search and essential for accessibility (e.g., for visually
impaired users)
Metadata Keywords: List of topics relevant to the page
(previously essential to SEO, now outdated for Google, Bing &
Yahoo!)
Search Engine Optimization: Improving Organic Results
© 2020 DIA, Inc. All rights reserved. Page 38

39. Review page titles, descriptions, URLs, and keywords with the
webpages
Submit to the Agency metadata that is likely to be seen by the
user (page titles, descriptions, and URLs, but NOT keywords or
Alt-tags) WITH the webpages
Keep in mind usability concerns, especially for products targeting
the visually impaired
Best Practices for Reviewing Metadata
© 2020 DIA, Inc. All rights reserved. Page 39