This presentation is no longer accurate. Google search has changed in ways that are not addressed in this presentation.

1. Current State of
Paid Search Marketing
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Presented by:
Dale Cooke
PhillyCooke Consulting
12 September 2014

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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.

3. Topics
1.Anatomy of a Paid Search Campaign
2.2009 Enforcement
3.New Ad Formats
4.FDA Guidance
5.Compliant Ad Formats
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4. Anatomy of a Paid
Search Campaign

5. Home of the Internet
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6. Home of the Internet
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Paid Search Highlighted in Red Boxes;
Organic Results in Blue Box

7. Elements of a Text Ad
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Sitelink &
Description
Display URL
Headline
Description
Destination URL:
http://www.lantus.com/starting/getting-on-track/lantus?
WT.mc_id=LNWB4274&WT.srch=1&iq_id=58226460-
VQ6-33575107656-VQ15-1t1-VQ16-c

8. Character-Count Limitations
Headline: 25 characters (18 on mobile)*
Display URL: 35 characters (20 on mobile)*
Description: 70 characters (18 on mobile)*
Sitelinks: 25 characters each
‣ Maximum of 10 links per campaign
‣ 2-6 will display with each ad
Sitelink Descriptions: 70 characters (0 on mobile)*
Destination URL: 2,048 characters
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* Character counts include spaces
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9. Mobile Has Less Real Estate
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10. 2009 Enforcement Action

11. The 14 Letters
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12. Sample Violative Material
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13. Three Acceptable Formats
1. Disease Awareness Ads
2. Reminder Ads
3. Redirecting Ads
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14. Disease Awareness Ads
‣ 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
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15. Reminder Advertising
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.”
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No compliant reminder ad was cited in the 14 letters
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16. Reminder Ads
1. Brand name (if applicable)*
2. Generic name*
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”)
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* Required 16

17. Redirecting Ads
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18. Redirecting Ads
‣ 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
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19. New Ad Formats

20. Black Box Drugs
‣ 14 of the 48 drugs cited had a black box
‣ Reminder ads are not permitted for black
box drugs
‣ None of the cited drugs was using an
otherwise compliant reminder ad format
Bayer’s Yaz
‣ Had a black box warning in 2009
‣ Cited as part of the 2009 letters
‣ Separately agreed to submit all materials
prior to use
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21. Google’s Black Box Format
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From 2009
FDA Hearings

22. A Few Weeks Later
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23. Sitelinks
“[S]itelinks … [are] links to specific pages on
your website beneath the text of your ads (and
in addition to the main landing page), helping
customers get to what they're looking for on
your site with just one click.”
—From Google Sitelink Description
https://support.google.com/adwords/answer/2375416?hl=en
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24. Sitelink Limitations
‣ Sitelinks won’t always appear
‣ Sitelink descriptions will not appear on
mobile
‣ Exact order of sitelinks might vary
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25. Mobile Ads
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Unique Constraints
Headline: 18 characters
Display URL: 20 characters
Description: 18 characters
Sitelinks: 25 characters
Sitelink
Descriptions: Will NOT appear

26. 2014 FDA Guidance

27. 27

28. FDA Recommendations
May provide benefit & risk in space-limited contexts so long as
message includes
1. Brand name
2. Generic name
3. Non-misleading indication statement
4. Abbreviated risk info (with ALL life-threatening risks)
5. Link to
a. Full risk information
b. Dosage form
c. Quantitative ingredient information
d. Full label
To save space, sponsors may
1. Use scientific abbreviation
2. Use linguistic symbols (e.g., & instead of “and”)
3. Use punctuation instead of words (e.g., — to separate
ideas) 28

29. Sample Message*
NoFocus (rememberine HCl)
(Brand & Generic Name—25 characters)
for mild to moderate memory loss
(Indication—34 characters)
May cause seizures in patients with a seizure disorder
(Risk Statement—54 characters)
www.nofocus.com/risk
(Display URL—20 characters)
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* This is a modified version of the Tweet example from the FDA
guidance. This message is too long for an SEM ad.
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30. FDA on Sitelinks
FDA suggests the following SEM ad:
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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
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31. Brand & Generic Name
Non-misleading Indication Statement
Balancing Risk Information Dedicated Link to Risk Information

32. What Users Would See
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This SEM ad does not meet
fair balance requirement
It is violative!
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33. !
Don’t Follow
FDA Guidance on
Use of Sitelinks

34. Compliant Ad Formats

35. Compliant Ad Formats
Reminder Ads include brand and generic
names with no representation of usage.
Redirecting Ads include no mention or
implication of a specific product, but redirect to
a product website.
Black Box Ads use Google’s dedicated line of
copy indicating severe warnings apply.
Disease Awareness Ads neither mention nor
imply any specific product and take users to a
disease awareness website. These are not
subject to FDA regulation when properly
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36. If using sitelinks
1. Do NOT include required information in the
sitelinks (e.g., generic name or balancing
risk information)
2. Make sure sitelinks are compatible with
overall ad format
a. If the main ad is a reminder ad, then the sitelink cannot
imply the product usage.
b. If the main ad is a redirecting ad that omits the product
name, then the sitelink cannot imply or name a specific
product.
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37. !
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Questions?
Dale Cooke
PhillyCooke Consulting
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PhillyCooke@Gmail.com
@PhillyCooke on Twitter
PhillyCooke.com
www.Scribd.com/Dale_Cooke
www.slideshare.net/PhillyCooke
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38. Speaker Bio: Dale Cooke
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Dale Cooke is the owner of PhillyCooke Consulting, which provides advice and training to
companies about developing compliant promotional materials for FDA-regulated products.
Dale has worked with more than 30 pharmaceutical and medical device clients around the
world. His insights have been featured in the Wall Street Journal’s Health blog, The Pink
Sheet, MedAdNews, PharmExec, and others. Dale is an active member of the Regulatory
Affairs Professionals Society (RAPS), Drug Information Association (DIA), Food and Drug Law
Institute (FDLI), and the Alliance for a Stronger FDA. He also serves on the faculty of the
University of California San Francisco’s American Course in Drug Development and
Regulatory Sciences program.
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Dale is the author of Effective Review and Approval of Digital Promotional Tactics, which is
part of FDLI’s primer 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.
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Dale earned his B.A. in Philosophy from Southern Methodist University, an M.A. in Analytical
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. 38