1. New Transparency and New Trust:
Bridging the Digital Divide in the FDA’s May 2009
Draft Guidance on Presenting Risk Information in
Prescription Drug and Medical Device Promotion
Carlen Lea Lesser Contributions by:
Associate Director, Interactive Strategy Croom Lawrence
RTC Relationship Marketing VP/Pharmaceutical Strategist
1055 Thomas Jefferson Street, NW Sara Weiner
Suite 200 Senior Manager, Interactive Strategy
Washington, DC 20007
202.625.2111
www.rtcrm.com/whitepapers
July 2009
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2. I. INTRODUCTION
In May 2009, the FDA released new draft guidance for presenting risk information in prescription drug and
medical device promotion. This new guidance covers both advertisements and promotional labeling for
drugs.1
The FDA makes it clear that this new guidance is intended to cover broadcast, print, and Web; however, while
it highlights many implications for print and broadcast, it offers only one example for the Web. Considering
the April 2009 release of 14 warning letters in a single day to pharmaceutical companies in regard to their
pay-per-click (PPC) search engine advertisements, it is not necessarily helpful to e-marketers that the FDA
offered only a single example for Web promotions. While much of the new guidance can effectively be
applied to digital media, the FDA has still left much to interpretation.
Key Takeaways
1. May 2009 FDA guidance officially covers digital, but few specific examples are provided
2. “Net Impression” and “Reasonable Consumer” standards now have greater prominence
3. Risk information must be treated equally with benefit information in the digital environment
4. Pharmaceutical marketers need to establish in-house guidelines for digital risk presentation
5. Pharma marketers need to embrace a more transparent approach to risk information
The core issue for the FDA and for marketers is one of transparency. The FDA’s goal is to ensure that
consumers receive a “balanced presentation of both the benefits and the risks associated with the
advertised” products.2 As marketers, our objective is not only to present products in the most compelling
and relevant way possible, but also to empower patients, caregivers, and healthcare professionals with
information to make better choices about their healthcare options. Regulation requires us to present fair
balance about the prescription medications we are promoting. The May 2009 draft guidance is signaling that
we must find a new approach focused on a more transparent presentation of both the benefits and risks.
This aligns with what consumers say they want from pharmaceutical companies 3 and many other industries,
so it may be a win-win situation, if marketers and pharmaceutical companies can move beyond their fears
around presenting potentially negative information to the public.
1
The May 2009 draft guidance does not apply to reminder ads, only to help-seeking and product claim ads and promotional materials.
For more information on these types of advertisements as the FDA defines them, see:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/default.html
2
“Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion.”
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf. May 2009. Page 3, lines 60-61.
FTC Policy Statement on Deception available at http://www.ftc.gov/bcp/policystmt/ad-decept.html
3
See: http://trendwatching.com/trends/transparency.htm, http://www.healthpopuli.com/2009/01/lack-of-transparency-causes-cynicism-in.html,
http://www.siegelgale.com/2009/01/14/president-obama-make-clarity-transparency-simplicity-a-priority-say-the-american-people/,
http://www.health2advisors.com/page9/page10/files/6806fa206dfa4cb8db0a75e94fb89dc4-15.html,
http://www.thenationaldialogue.org/healthit/ideas/pharma-fda-and-consumers-in-a-2-0-age
New Transparency and New Trust 1

3. With this in mind, RTCRM believes that the most important next step for pharmaceutical companies is
to collaborate with regulatory teams to develop relevant, specific guidelines that reflect the spirit of the
FDA draft guidance document. The digital environment is unique and too complex to attempt to use
print formats as the standard. Even more important, based on this new guidance, RTCRM recommends
implementing an analytical framework for testing risk perception and fair balance in all digital work.
Following are digital examples that marketers, brand managers, and MedReg teams can use to develop in-
house guidelines and testing requirements for the presentation of fair balance in digital advertisements and
promotional materials that will be fully compliant with the May 2009 draft guidance. This will also help us all
achieve our common goal of empowering the public to make better, more educated healthcare decisions.
II. NET IMPRESSION AND
THE REASONABLE CONSUMER
The new materials issued by the FDA are not new regulations, but rather guidance that amounts to
additional clarification on the regulations and how to apply
them. The FDA is now offering more specific information
around what “fair balance” really means and how it will be
judged. Fair balance will be judged against two standards: Reasonable Consumer
1) how a marketing piece is interpreted by a “reasonable Standard
consumer” and 2) the Net Impression that the marketing
4
“The reasonable consumer standard
piece creates. more accurately reflects FDA’s belief
that consumers are active partners
The Reasonable Consumer Standard. in their own health care who behave
While not new, the May 2009 guidance brings renewed in health promoting ways when
emphasis to the “reasonable consumer standard” as defined they are given accurate health
by the Federal Trade Commission.5 The FDA makes it very information.”
clear that the target consumer should be considered when
From: Federal Register, Vol. 67, No. 245: Notices.
developing and placing material in market. They refer to this Friday, December 20, 2002
average target as the “reasonable consumer.” When evaluating
how a reasonable consumer may interpret marketing material,
they state: “To be considered reasonable, the interpretation or
reaction does not have to be the only one. When a seller’s representation conveys more than one meaning to
reasonable consumers, one of which is false, the seller is liable for the misleading interpretation.”6
4
“Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion.” http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf. May 2009. Page 5, line 159.
5
FTC Policy on Deception available at http://www.ftc.gov/bcp/policystmt/ad-decept.htm
6
“Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion.”
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf. May 2009. Page 6, lines 169-171.
New Transparency and New Trust 2

4. Net Impression.
The second standard for measuring compliance is the Net Impression.
Net Impression is a combination of two primary elements:
1. Content
2. Formatting
The FDA breaks these two areas down into 18 separate
elements. How each of these elements creates the Net
Impression, especially in a digital environment, is what Net Impression:
needs to be explored. Is the Net Impression the entire path
“the message communicated by all
the consumer takes, or each piece as a stand-alone? In a
elements of the piece as a whole”
print environment, you see the ad in a magazine with the
fair balance and that is the end. By nature, digital requires a From: FDA Draft Guidance for Industry:
Presenting Risk Information in Prescription
consumer to actively navigate multiple pieces of content in
Drug and Medical Device Promotion
one “experience” or sitting.
Example: Search engine to landing page could be a Net
Impression, email to website could be a Net Impression, a
website-to-website navigation could be a Net Impression.
For the purposes of this white paper, we will treat digital pieces as stand-alones and look at the Net
Impression of a single webpage or ad.
The foundation of the Net Impression standard is the “reasonable consumer.” The emphasis on this standard
requires pharmaceutical companies to firmly establish and document who the target audience of all
advertising and promotional materials is. Establishing who the target audience is (or audiences are) for the
promotions will also allow pharmaceutical companies to test for fair balance before submitting a piece for
FDA “Date of First Use” (DOFU) approval. This documentation will also be of assistance in documenting
empirical evidence that the risks and benefits were understood by the target audience, should they receive
any warning letters from the FDA.
Action Item: RTCRM recommends 1) developing target audience personas, and 2) implementing
Net Impression–focused testing on all digital pieces.
What Is a Persona?
A persona is a written or visual
holistic description of the target
audience that allows the marketer
to understand demographic groups
as unique individuals.
New Transparency and New Trust 3

5. A. Target Audience Personas
It can be difficult when reviewing materials to see through the eyes of others, which is why marketers
often use a tool called “personas.” The use of a persona can set a consistent scene for all reviewers to judge
appropriateness of language and overall Net Impression of benefit and risk information. Elements of a persona
should include any consumer variables that may affect how a marketing piece is interpreted:
• Role (e.g., patient, caregiver, HCP)
• Condition
◊ Information-seeking or diagnosed
◊ Time since diagnosis
• Age
• Education level
• Private insurance or Medicaid
• Native English speaker or ESOL
• Demographics
• Psychographics
• Technographics
B. Net Impression Testing
Testing for Net Impression need not be an expensive or expansive proposition in a digital context. The
approaches used for usability testing can easily be applied to this as well. This includes the smaller sample sizes
used in usability testing. Quantitative studies have shown that within any segment, a maximum of 10-15 people
are required to achieve a valid test.7 Beyond that there is a greatly diminished rate of return.
Sample Test Structure:
1. Using approved personas, recruit test subjects
2. Expose test subjects to website, ad, or other materials for average length of time a person would view the
piece in-market
3. Question the test subject about their impression of the Rx presented
a. Quantitative: numerical scale of positive to negative
b. Qualitative: verbal expression of impression
4. Question the test subject about risks and benefits
a. What risks can they remember?
i. Capture both number of risks remembered and which had highest recall
b. What benefits can they remember?
i. Capture both number of benefits remembered and which had highest recall
c. Can they restate who the Rx is indicated for?
d. Can they restate who should not take the Rx?
This format can be applied to any digital marketing materials and may even be able to be combined with
usability testing for further efficiency.
7
Krug, Steve. Don't Make Me Think: A Common Sense Approach to Web Usability. 2nd ed. Berkeley, CA: New Riders Press, 2005.
New Transparency and New Trust 4

6. III. IMPLICATIONS FOR DIGITAL
The FDA provided many clear examples for print and broadcast advertising and promotions, but only one
example for digital. Based on the draft guidance, the largest changes may need to be in how brands approach
digital marketing. The following is not a comprehensive list of all possible digital implementations, but focuses
on the ones least clear from the draft guidance. For example, we have not included online video, because the
broadcast examples apply very directly to online video as well.
Following are digital examples, based on the draft guidance, to discuss with your legal team. This is not
intended as legal advice, nor is the example comprehensive of all possible issues.
A. Branded Websites
Below is a wireframe example of a standard branded pharmaceutical website’s homepage. This is a composite
of five major pharmaceutical websites currently in market. On this fictitious homepage there are at least four
major violations of the new guidance.
1. “Important Safety Information” grouped in with “utilities”
2. No risk information above the fold line
3. “Important Safety Information” headline treatment and specificity issues
4. Risk information presentation issues
New Transparency and New Trust 5

7. 1. Important Safety Information (ISI) as “utility”
This is a common practice on pharmaceutical websites, which is highly questionable in light of the draft
guidance. The primary concern is that grouping the ISI with the utilities signals that this is useful, but
not important, information. There is also a hierarchy issue, as many times the ISI is listed in the middle of
several other links, further minimizing it.
Action Item: To address these issues, RTCRM recommends separating out the ISI and “Prescribing
Information” (PI) links from the true utilities such as “send to a friend”
2. Risk information below the fold
While the quantity of risk information provided equals the quantity of benefit information on the page, its
location presents concerns. In the May 2009 draft guidance, the FDA states:
“In addition to appearing with or near benefit presentations, risk information should appear as an
integral part of the piece, just as benefit information does.”8
By placing all risk information well below the fold, it is reasonable to assume that the average consumer
may not be exposed to it. However, this is debatable. As Internet and even mobile penetration increases, it
becomes less and less likely that a reasonable consumer does not know to scroll. Usability testing outlined
in Section II.2 can help establish a standard for this topic.
Rx brands with a boxed warning have already implemented one possible option that other prescription
brands could explore. Many “black box” brands are including the beginning text of their “Important
Safety Information” at the top of the page, with a link to the rest at the bottom. This ensures that at least
part of the fair balance is always well above the fold and clearly provides both benefit and risk in any Net
Impression.
Action Item: Ensure some risk information is visible above the fold on average monitor
resolution
3. “Important Safety Information” headline treatment and specificity
The “Important Safety Information” headline presents two specific concerns around font size and style and
framing.
The font size and style of the ISI on most websites are generally plain HTML text and all other headlines are,
more often than not, graphical. If the benefit headlines are not graphical, they are generally a different color
and size.
The second issue with the standard ISI headline is what the FDA calls “framing.” Under this new guidance the ISI
headline should include the brand name of the drug.
8
“Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion.”
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf.
May 2009. Page 16, lines 558-559.
New Transparency and New Trust 6

8. Action Item: “Important Safety Information” must have a headline and should be the same font
size and style as other headlines on the page and include the name of the drug (e.g., Important
Safety Information about Brand X)
4. Risk information presentation
Of greatest concern on most pharmaceutical websites is the physical presentation of the risk information.
Standard practice in the pharmaceutical industry is to provide the risk information in a dedicated section
at the bottom of each page of a website. See detail of standard “Important Safety Information”
implementation below:
The “Important Safety Information” is generally presented as a wall of text, and often with smaller fonts than
the main body (benefit) information. Often websites will provide a visual signal that the content has ended
through:
A. Visual indicator that page is done
B. Change in background color
C. Change in font color and size to smaller, lighter weight
D. Text presented as large block9
E. Footer navigation and copyright information given equal weight
9
See: http://blog.pharmexec.com/2009/06/25/building-a-better-brief-summary/ for more on recent FDA studies around this concept.
New Transparency and New Trust 7

9. The FDA states several times in the draft guidance that risk information must appear to the average
consumer to be a part of the content, not separate information, to be considered fair and balanced. Using
these types of devices minimizes the importance of the content and could lead the FDA to determine that
the site is misleading.
In addition to signaling that the “real content” has ended through visual cues, the content of the risk area is
generally presented as a wall of text. Based on the new guidance, the content should be presented as core
content and be scannable. Best practices in developing Web content (e.g., headlines, bullets, chunked content)
should also be applied to the “Important Safety Information” section of the website.
Action Item: Apply same or visually equal style to “Important Safety Information” as the benefit
information
B. Branded Banners
Branded banner advertisements fall into two main categories:
1. Animated Banners (SWFs and GIFs)
2. Rich Media
The first is a simple animated banner with little to no interactivity. The second is only limited by the
imagination and budget, and can provide deep, rich functionality. Finding the space for fair balance in small
banner advertisements can be a challenge, and the new guidance will only increase the challenge. Due to the
April 2009 warning letters raising questions about the validity of the “one-click” rule for fair balance, we have
seen a decline in standard banner ads that do not allow at least minimal interactivity to surface fair balance
within the ad.
The key issues for fair balance in banner ads, under the new guidance, are similar to those impacting branded
websites. Primarily the issue with banner ads tends to be one of satisfying format requirements:
“As a general matter, risk and benefit information should be comparably noticeable or
conspicuous in promotional pieces, and audiences should be able to read both risk and
benefit information with similar ease... .” 10
Below are two wireframes of very standard pharmaceutical banner ad layouts:
10
“Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion.”
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf. May 2009. Page 15, lines 528-530.
New Transparency and New Trust 8

10. There is nothing inherently “wrong” with either layout. The potential issues arise with specific
implementations.
For comparison, here are two wireframes of pharmaceutical ads currently in market that are representative of
standard practices:
1. Treatment of risk information
The tiny links to the “Prescribing Information” and ISI are potential issues here. Their proximity to the brand
benefits is in line with the recommendations, but extremely tiny font size does signal that this information is
less important than the large brand benefits above.
Action Item: Apply same or visually equal style to the ISI as the benefit information
2. Scrolling “Important Safety Information”
Both ad formats utilize the scrolling “Important Safety Information.” The issue with this implementation is
that, in the end, it may actually minimize the importance of the risks, as the lead copy in each only references
the indication – not the risk. In both cases, the brand name is also never mentioned directly with the words
“Important Safety Information.” The change in font size and style can potentially signal that this is less
important than the benefit information.
It is important to note that the scrolling ISI is somewhat preferable to an on-click ISI. The scrolling ISI does
elevate the importance over the small button that simply says “Important Safety Information.” The specific
issue here is that the allowable space for the ISI is too small to actually read the ISI or see any of the safety
information without scrolling. Alternative versions of the scrolling ISI, which expose the majority of the ISI at
first glance and then are automatically minimized for the viewer, with an option to see on-click, are more in line
with the spirit of the new guidance.
Action Item: Avoid static scrolling ISI in tiny box or ensure that some risk information is visible
without scrolling. Use brand name with words “Important Safety Information”
New Transparency and New Trust 9

11. 3. Framing of boxed warning
The framing of the boxed warning with “Prescribing Information” and the Medication Guide could minimize
the impact of the boxed warning. There is specifically a hierarchy issue, with it being in the middle of a list of
other items.
Action Item: Display true domain names in all PPC ads
The net takeaway for branded banner ads, both simple and rich media, is that the fair balance needs to be easily
consumed and understood by the average target viewer. This is easily achieved with rich media ads, and based
on ads currently in market, possible with simple Flash-based banners as well.
C. Branded Search Ads (PPC)
Branded pharmaceutical pay-per-click (PPC) ads were the target of 14 warning letters from the FDA in
April 2009. These letters raised new questions about the viability of this type of branded advertising for
pharmaceutical brands. The core issue was the lack of fair balance. Unfortunately, the FDA has not provided
specific examples for PPC ads in the latest draft guidance.
Based on the April 2009 warning letters and the May 2009 draft guidance, pharmaceutical companies are best
off avoiding branded search advertisements, other than reminder ads.
Here is a fictional example of this type of potentially misleading redirect ad:
1. Misleading URL
Pharma is the only industry allowed by Google to display a false domain name in a search advertisement. All
other industries are required to display the true domain name that the visitor will be directed to upon clicking.
This illustrative ad is unquestionably misleading, as the viewer has no reason to believe he/she will click
through to a branded website from either the copy or the domain name.
Action Item: Display true domain names in all PPC ads
In May 2009, RTCRM issued a detailed white paper about the impact of the 14 FDA warning letters on search
engine marketing, titled “An Eye on Google: Re-Engaging with Digital Marketing in Response to Recent FDA
Warnings,” which can be downloaded at www.rtcrm.com/whitepapers.
New Transparency and New Trust 10

12. D. Organic Search Listings
The final area of consideration under the new
draft guidance is organic search. The FDA has
never offered official guidance on this channel, Yahoo! Search Listing
but it could be covered under the new draft
guidance.
While not all elements of organic search
display are controlled by the brand, RTCRM
highly recommends close vetting of titles and
descriptions, which are the controllable elements
of organic search. With organic search, character
counts, unlike with paid search, are much longer
and do allow for the inclusion of risk terminology.
By reviewing and carefully writing titles and descriptions to include the ideas
of benefits and risks alike, pharmaceutical marketers can avoid noncompliance
Bing.com issues, and actually improve the patient experience moving forward. Sometimes,
“More the search engines will pull from body copy rather than from the description.
Information” Marketers do not have control over this, as it is an engineering and technical
function. Another element marketers do not always have control over are the
sporadic links that Google sometimes displays under organic listings.” 11 But,
marketers do have some control over what links appear in Microsoft’s new search
engine, Bing.
Based on the structure of the Yahoo! search engine, there is a built-in sense
of fair balance, as they present articles about side effects from Yahoo! Health
above the branded results. In RTCRM’s opinion, the Net Impression of branded
search results on Yahoo! is very balanced, because of this unique search-results
structure. Microsoft’s new search engine, Bing, also has built-in elements that
assist with the inclusion of fair balance in organic search listings. Bing has a special
“more information” call-out that displays, among other information, the first
links the search engine discovers on the page. In most cases “Important Safety
Information” and “Prescribing Information” are included in this list.
Marketers can ensure that one of these links, at least Bing, always contains safety information by carefully
coding their websites. Marketers can also always use FDA-compliant titles and descriptions, and then the entire
organic listing would provide the proper user experience based on recent FDA guidance. More information on
Google organic search optimization can be found at http://www.google.com/webmasters/.
11
Excerpted from “An Eye on Google: Re-engaging with Digital Marketing in Response to Recent FDA Warnings,” by Sara Weiner. Available at
www.rtcrm.com/whitepapers
New Transparency and New Trust 11

13. IV. Risk Evaluation Matrix
The FDA draft guidance outlines many elements that make up fair balance. There are few elements that on
their own are a high risk. It is the combination that creates the Net Impression. If your site has a high number of
medium-risk elements, that could lead to a Net Impression issue.
Digital Net Impression Risk Evaluation
Risk Tactic Issue Recommendation
ISI placed in middle of Separate out the ISI and PI links from the
Branded
M utility navigation signals safety true utilities such as “send to a friend.”
Website
information is of low importance Consider placing in primary navigation
ISI headline does not include brand name,
Branded Include brand name with
M which creates framing issue, as benefit
Website “Important Safety Information” headline
information generally includes brand name
ISI font size and style are different from
Branded other content on page, signals lower Match headline and body copy font size
H
Website importance of safety information and styles in ISI and rest of page content
compared with other content
Change in background color in ISI section
Branded Incorporate ISI as content on the page
M could signal that page has ended and that the
Website – not part of the footer
rest of the information is unimportant
ISI font size and style are different from
Branded other content on page, signals lower Keep font size of ISI links, at minimum,
H
Banner Ads importance of safety information the same as smallest benefit information
compared with other content
Branded Static ISI does not provide Use auto-scrolling ISI or ensure that some risk
M
Banner Ads safety information at a glance information is visible without scrolling
ISI headline does not include brand name,
Branded Include brand name with “Important
M which creates framing issue, as benefit
Banner Ads Safety Information” headline
information generally includes brand name
Boxed warning presented in middle of
Branded Place boxed warning at
H list of items, which frames it with less
Banner Ads beginning or end of list
important items and reduces impact
continued...
New Transparency and New Trust 12

14. Digital Net Impression Risk Evaluation (cont'd)
Risk Tactic Issue Recommendation
Unbranded Unbranded ad that clicks through to
H Direct unbranded ads to unbranded websites
Search Ads branded website is misleading
Branded Branded ad includes product and Either only use product with generic name and
H
Search Ads benefits, but no fair balance not benefits, or include risk12
Take active steps to have ISI link included
Branded
Organic search listing does not in optional links and include word “risk” along
L Organic
contain any fair balance with benefits in descriptions that include
Search
benefit information
V. Conclusion
In the end, each pharmaceutical company will need to work with its legal team to make any final decisions
regarding digital tactics and how to effectively deliver against the true intention of the latest FDA guidance
documentation.
The new guidance does provide additional clarity as to what is and is not acceptable in the realm of “fair
balance” in a digital environment, but it also opens new questions. What is clear is that marketers, both brands
and agencies, will need to create new ways of establishing, testing, and documenting what is reasonable to the
average consumer and the Net Impression of all digital marketing tactics.
Small changes to a piece can make a big difference in the Net Impression. While it is counterintuitive to
marketers to highlight the downsides of a product, engaging in a new sense of consumer-centric transparency
is a must to be compliant with the draft guidance on risk presentation. Consumers may even appreciate
the more balanced approach, and new trust may develop between the consumer and the brand. Either way,
pharmaceutical companies and agencies will need to cast a critical eye on the way fair balance is approached to
ensure compliance with the new guidance.
12
See: “An Eye on Google: Re-engaging with Digital Marketing in Response to Recent FDA Warnings,” by Sara Weiner. Available at
www.rtcrm.com/whitepapers
New Transparency and New Trust 13

15. APPENDIX: ELEMENTS OF NET IMPRESSION – A REFERENCE GUIDE
This is a guide to applying some of the key elements of Net Impression, as detailed in the FDA’s May 2009 draft
guidance on presenting risk information. This guide is not comprehensive, but rather details specific elements
that have a large impact on Net Impression in a digital environment.
1. Target-appropriate language
Use accurate language that consumers will easily understand
Guideline: Avoid scientific language in consumer materials
Appropriate language is one of the easier standards to comply with, as most pharmaceutical companies have
already been applying this for some time. Target audiences are generally determined by the population a
medication is indicated for, but there is always a wider audience to whom we are speaking. The use of personas,
as detailed above, will help to determine if the language is truly appropriate. Not only will personas help
marketers create better communications, they can also serve as a point of reference for MedReg in evaluating
whether or not the language is appropriate.
Target-Appropriate Language Checklist:
 Do you have an agreed-upon persona or personas?
 Is the content relevant to the persona?
 Is the content easily digestible by that persona?
2. Hierarchy of information
The presentation order of the risk and benefit information
Guideline: In video, the most important risks should be presented at the beginning or the end. In text, the most
important risks should be presented first
There are two issues to consider with hierarchy of information, both having to do with how people process
information. The first is simply that people remember information at the beginning or end better than what
was presented in the middle. The second is that the order of the information may lead people to group
information that the brand did not intend to have grouped.
FDA Example 13 : “Patients should not drink alcohol when taking Drug X. Common side effects are drowsiness
and nausea.”
The order of this information may lead a reader to conclude that the nausea and drowsiness occur only when
people take the drug with alcohol.
Hierarchy Checklist:
 Are the most severe risks listed first?
 Are like types of risks grouped together?
13
“Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion.”
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf.
May 2009. Page 10, lines 333-336.
New Transparency and New Trust 14

16. 3. Framing
Risk and benefits must be specifically stated and include statements that would minimize the severity of a risk
Guideline: Be specific and use the brand name when describing both risks and benefits
The FDA is clearly indicating that pharmaceutical companies must be specific when discussing risks, to
avoid minimizing the risk to the average consumer. The first and simpler guidance is that the brand name
be used both when benefits and risks are mentioned. The second and more subjective guidance is around
specificity of risks.
FDA Example14 : A drug’s package insert contains a boxed warning about the risk of life-threatening fevers
associated with its use and reports that 55% of patients taking the drug experience dizziness.
Unacceptable
“Adverse events associated with drug X include fevers. Some patients experienced dizziness.”
Acceptable
“Life-threatening fevers have been reported with the use of Drug X.”
“More than half of patients taking Drug X experienced dizziness.”
Framing Checklist:
 Are you using the brand name consistently with both risks and benefits?
 Is the risk information specific?
4. Quantity and comprehensiveness
Treat risk and benefit information equally in the content
Guideline: Devote equal time, space, and formatting to the benefits and risks alike
“The treatment of risk information in each piece should be comparable to the treatment of benefit information,
including how it is conveyed.” 15 The FDA has stated clearly here that they expect the risk information to be
treated equally with the benefit information. This includes:
• Have an equal number of statements about risks and benefits, equal level of detail about each
5. Signals
Using writing devices to emphasize or call attention to content
Guideline: Use consistent emphasis on all headers and copy, whether involving benefit or risk
The use of signals is an inherent part of most webpages. HTML code is built around content hierarchy and the
use of semantic code has been a best practice for some time. The HTML tag “H1” indicates the most important
14
“Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion.”
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf.
May 2009. Page 9, lines 289-296.
15
Ibid, page 11, lines 365-366.
New Transparency and New Trust 15

17. headline on a page, and is generally only used once. The “H2” tag indicates a second-level headline and should
be used to highlight all second-level content headlines, whether about benefits or risks.
The clear guideline here is that if your main benefit headline is 12 pixels, then your “Important Safety
Information” headline should be 12 pixels. The same goes for the body copy in the benefits area and the risks
area; they should be the same font size. These signals are especially important in a Web environment, where
studies have shown that people tend to scan the pages instead of reading them. This also applies to the use of
voiceovers and supertitles in video.
Signals Checklist:
 Is the font size and styling of the “Important Safety Information” headline the same as the main
benefit headline?
 Is the content of the ISI laid out in the same manner as the body copy of the benefits section?
 Is the font size of the ISI body copy the same as the body copy for the benefits area?
 Is the ISI content as scannable as the benefit information?
 Is risk information visible above the fold?
6. Location of risk information
Risk information should appear as an integral part of the piece
The new guidance around hierarchy of information may require the most changes for brand websites. The
FDA states that “...risk information should not just be presented in one location in a piece, but should, like
benefit information, appear as an integral part of the piece.” 16
This is a change from current practices on most brand websites. The standard industry approach has been to
place the complete “Important Safety Information” at the very bottom of the page in a dedicated section.
Most, if not all, brand sites do include a clearly labeled “Important Safety Information” jump-link at the top of
the page, but the acceptability of this approach is now in question.
16
“Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion.”
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf.
May 2009. Page 10, lines 326-327.
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18. About RTC Relationship Marketing
RTC Relationship Marketing (RTCRM) is a full-service direct marketing and relationship marketing agency
based in Washington, D.C., in the heart of Georgetown, with offices in New York and Chicago. RTCRM boasts
more than 40 years’ worth of innovative, targeted solutions that grow its clients’ brands and help them forge
lasting, valuable relationships with their customers. What distinguishes RTCRM is its unique ability to analyze
data and research on both a rational and emotional level. RTCRM’s clients include major brands in the telecom,
technology, pharmaceutical, and other business sectors, such as AARP, GlaxoSmithKline, and Time Warner
Cable. RTCRM’s innovative campaigns have won numerous advertising and direct marketing awards. RTCRM
is part of the WPP Group, one of the world’s largest communications companies, which includes Wunderman,
Y&R, Ogilvy & Mather Worldwide, JWT, and Landor. To learn more about RTCRM, please visit www.rtcrm.com.
RTC Relationship Marketing Headquarters in Washington, D.C.
1055 Thomas Jefferson Street, NW
Suite 200
Washington, DC 20007
202.625.2111
www.rtcrm.com/whitepapers
New Transparency and New Trust 17