Executive summary presentation I developed for the RTCRM whitepaper of the same name written by Sara Weiner, Croom Lawrence, and Carlen Lea Lesser that provides guidance for digital marketing after the 14 simultaneous warning letters the FDA issued in April 2009 to pharmaceutical companies in regards to their Google Ads. The impact of these warning letters goes far beyond PPC ads, and ideas on how to deal with this new regulation are outlined in the presentation and more deeply in the whitepaper (http://www.rtcrm.com/whitepapers).

1. Executive Summary
An Eye on Google:
Re-engaging with digital marketing
in response to recent FDA warnings
5/5/2009

2. Agenda
 Overview
 14 Warning Letters Issued by FDA in One Day
 What the FDA Said
 Black Box vs. Non–Black Box
 Google Search Ad Specifications
 One-Click Rule
 Search Ad Copy Risk Evaluation
 Google Exception to Avoid
 Implications Beyond Search Ads
 Why Invest in Rich Media?
 Summary
 More Information
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3. Overview
 The FDA has warned that paid search copy without safety
information creates a misleading experience for patients,
establishing a precedent of concern about all digital tactics
 For paid search, the issue is primarily in the functionality and
logistics of the search engine technology
 There are best practices in paid search that can protect your
pharmaceutical brand from noncompliance
 The One-Click Rule may still apply in some scenarios
 Rich media banners are the best approach for materializing a
patient’s digital experience alongside safety information
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4. 14 Warning Letters Issued by FDA in One Day
“Fail to communicate any risk”
Source: U.S. Food and Drug Administration, Center for Drug Evaluation and
Research. “Warning Letters and Untitled Letters to Pharmaceutical
Companies 2009.” (April 2009) http://www.fda.gov/cder/warn/warn2009.htm
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5. What the FDA Said
For promotional materials to be truthful and non-
misleading, they must contain risk information in each
part as necessary to qualify any representations and/or
suggestions made in that part about the drug.
(Biogen/Tysabri letter)
Source: U.S. Food and Drug Administration, Center for Drug Evaluation and
Research. “Warning Letters and Untitled Letters to Pharmaceutical
Companies 2009.” (April 2009) http://www.fda.gov/cder/warn/warn2009.htm
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6. Black Box vs. Non-Black Box
Boxed Warning No Boxed Warning
Source: U.S. Food and Drug Administration, Center for Drug Evaluation and
Research. “Warning Letters and Untitled Letters to Pharmaceutical
Companies 2009.” (April 2009) http://www.fda.gov/cder/warn/warn2009.htm
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7. Google Search Ad Specifications
 Text only
 Total of 95 characters maximum, including spaces
 Headline: maximum of 25 characters, including spaces
 2 description lines: maximum of 35 characters, including spaces
 Destination URL
25 Character Headline
35 Characters for the second line
35 Characters for the third line
www.DestinationURL.com
Sample Character Counts: 1st line is 22 chars,
2nd line is 33 chars, 3rd line is 32 chars
No Ability to Include Fair Balance in Ad
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8. One-Click Rule
 General “rule” is to provide safety information within one
click from the ad
 Interpretted for text ads as allowing Fair Balance to
reside on destination website
 No formal FDA guidance until April 2009
 Guidance appears to state Fair Balance must appear in actual
branded ad
 One click to website for Fair Balance no longer acceptable
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9. Search Ad Copy Risk Evaluation
Search Ad Copy Risk Evaluation
Risk Keyword Query Sample Ad Copy Landing Page Issue
• Similar to accepted reminder ads
Brand Official Site
• Not permitted for Black Box brands
Full Generic Molecule.
Low Brand www.brand.com
• Safety information should be on landing page (one click)
Safety Information Here.
• Requires legal approval on case-by-case basis
www.Brand.com
Osteoporosis Management
• Similar to accepted help-seeking ads
Osteorporosis Learn Tips and Get Support to Help
• Requires legal approval on case-by-case basis
Low www.unbranded.com
Manage Your Osteoporosis
management • No safety information needed
www.unbranded.com
Brand Official Site
• Acknowledges risks, but doesn’t provide material up front
Learn About Benefits and Risks of
• Safety information should be on landing page (one click)
Mid Brand www.brand.com
Treating Osteoporosis with Brand
• Requires legal approval on case-by-case basis
www.Brand.com
• Unbranded to branded material, similar to regulated product
Brand Official Site claim ads
• Misleading indication experience for unbranded keyword
Osteorporosis Full Generic Molecule
High www.brand.com
Safety Information Here search
management
• Need safety information available
www.Brand.com
• FDA letters warned against this
Osteoporosis Management
• Unbranded to branded material, similar to regulated
Learn Tips and Get Support to
Osteorporosis product claim ads
High Help www.brand.com
• Misleading landing page for unbranded keyword search
management Manage Your Osteoporosis
• FDA letters warned against this
www.Brand.com
• Unbranded to branded material, similar to regulated
Osteoporosis Management
Osteorporosis Learn Tips and Get Support to Help product claim ads
High www.brand.com
• Misleading display URL for unbranded keyword search
Manage Your Osteoporosis
management
• FDA likely to warn against in future
www.healthybones.com
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10. The Google Exception to Avoid
 Pharma is the only industry allowed to have “deceptive”
domain name in an ad
 All other industries are required to show actual
destination domain name.
Osteoporosis
Learn about healthy bones
www.brand.com
and understanding your risks
www.healthybones.com
Unbranded Ad  Branded Landing Page = Non-Compliant
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11. Implications Beyond Search Ads
Digital Media Risk Evaluation
Risk Tactic Issue Recommendation
Revisit idea of including “risks” in titles and descriptions to
Technical function of organic
Low Organic Search search leaves some copy out of meet FDA compliance. Work closely with SEO agency to
marketer’s control. implement pharmaceutical principles.
Best option for creating
Follow best copy practices and include safety information
comprehensive and explanatory
in its own panel. Use rich media as a microsite
Low Rich Media Banners patient experience. Plenty of room
experience to promote both branded and unbranded
to include safety information upon
content.
first exposure.
Short ad copy requirements result Continue with unbranded search keywords and copy, but
Mid Paid Search in mandatory click-through to view maintain best practices. Review branded copy on case-
safety information. by-case basis with legal team.
Similar to paid search. Lack of Follow similar best practices for paid search and
space for safety information in concentrate on unbranded copy to unbranded website.
High Banners
banner creates need for click- Option to include multiple click tags within banners to
through to website. provide safety information upon exposure.
Inability for proactive control of Continue with content targeting, but actively monitor
contextual material that appears distribution reports. Use very generic and conservative
High Contextual Targeting
next to your ad may create copy. Unbranded would be best approach. Branded not
misleading experience for patient. generally recommended. No Black Box.
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12. Why Invest in Rich Media?
 Better engagement opportunities  Better ad awareness
 Immediate data capture  Better message recall
 Integrated Fair Balance
Rich media increases ad awareness
Rich media increases message
for all industries
association for many industries
Message Association Online Ad Awareness
13.5
GIF/JPG 11.2
10.1
9.4 9.5
Rich Media
Above Control
Above Control
8.5
Average Delta
Average Delta
7.7
7.4 7.1
7.0
6.5 6.9
6.1 6.3 6.2
5.5 5.4 5.5
5.1 4.9 4.6 4.9
4.8
3.9 3.7 4.1 4.4 4.2 4.3
3.8 3.5
1.0
Auto CPG Elec. Ent. Fin. Pharma Tech Trav. Auto CPG Elec. Ent. Fin. Pharma Tech Trav.
Svcs. . Svcs. .
Source: Dynamic Logic MarketNorms, Q2 2005; Delta equals Exposed minus Control;
Note – Electronics and Travel contain fewer than 30 campaigns for GIF/JPG
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13. Summary
1. FDA warned 14 pharmaceutical companies in one day that dozens
of brands’ PPC ads were “misleading” and lacked “risk” information
2. Majority of brands implicated did not have Boxed Warnings
3. Risk information must be included in search ads, One-Click Rule is
no longer operative
4. Google’s “pharma exception” is to be avoided, as it is not in
compliance with unbranded-to-branded regulations
5. Implications are beyond text ads. New guidance must be
considered with banner ads and organic search
6. Rich Media offers the best branded opportunity for digital media
both in ROI and compliance with FDA regulations
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14. More Information
 This presentation is a summary of the RTCRM white
paper An Eye on Google: Re-engaging with digital
marketing in response to recent FDA warnings written by
Sara Weiner with contributions from Croom Lawrence
and Carlen Lea Lesser.
 Download the complete white paper at
www.rtcrm.com/whitepapers or request a copy from your
RTCRM account manager.
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