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.
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
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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
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6. Home of the Internet--SERP
Home of the Internet: SERP
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7. Search Engine Results Page
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Paid Search (SEM) in red box
Organic search in blue box
Knowledge panel in green box
8. Anatomy of a Text Ad
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Destination URL:
https://www.nexletol.com/
Headline
Display URL
Sitelinks
Description
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
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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
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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
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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
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20. FDA Guidance
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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
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* 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
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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…
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24. FDA on Site Links
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“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
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26. ‣ Sitelinks won’t always appear
‣ Sitelink descriptions will not appear on mobile
‣ Exact order of sitelinks might vary
Sitelink Limitations
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27. FDA on Site Links
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Balancing Risk
Information
28. FDA on Site Links
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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
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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
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
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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
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