New Transparency and New Trust: Bridging the Digital Divide in the FDA’s May 2009 Draft Guidance...

New Transparency and New Trust:Bridging the Digital Divide in the FDA’s May 2009 Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion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 Associate Director, Interactive Strategy

RTC Relationship Marketing 1055 Thomas Jefferson Street, NW Suite 200 Washington, DC 20007 202.625.2111 www.rtcrm.com/whitepapers

July 2009

Contributions by: Croom Lawrence VP/Pharmaceutical Strategist

Sara Weiner Senior Manager, Interactive Strategy

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1 The May 2009 draft guidance does not apply to reminder ads, only to help-seeking and product claim ads and promotional materials.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

Key Takeaways1. 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 companies3 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.

I. INTRODUCTIONIn 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.

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New Transparency and New Trust 1

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.htm6 “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.

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: 1) how a marketing piece is interpreted by a “reasonable consumer”4 and 2) the Net Impression that the marketing piece creates.

The Reasonable Consumer Standard. While not new, the May 2009 guidance brings renewed emphasis to the “reasonable consumer standard” as defined by the Federal Trade Commission.5 The FDA makes it very clear that the target consumer should be considered when developing and placing material in market. They refer to this 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

Reasonable Consumer Standard“The reasonable consumer standard more accurately reflects FDA’s belief that consumers are active partners in their own health care who behave in health promoting ways when they are given accurate health information.”

From: Federal Register, Vol. 67, No. 245: Notices. Friday, December 20, 2002

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Net Impression.The second standard for measuring compliance is the Net Impression.Net Impression is a combination of two primary elements:1. Content2. 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 needs to be explored. Is the Net Impression the entire path the consumer takes, or each piece as a stand-alone? In a print environment, you see the ad in a magazine with the fair balance and that is the end. By nature, digital requires a consumer to actively navigate multiple pieces of content in 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 fi rmly 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 benefi ts 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.

Net Impression:“the message communicated by all elements of the piece as a whole”

From: FDA Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion

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.

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7 Krug, Steve. Don't Make Me Think: A Common Sense Approach to Web Usability. 2nd ed. Berkeley, CA: New Riders Press, 2005.

A. Target Audience PersonasIt 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 TestingTesting 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 subjects2. Expose test subjects to website, ad, or other materials for average length of time a person would view the

piece in-market3. Question the test subject about their impression of the Rx presented a. Quantitative: numerical scale of positive to negative b. Qualitative: verbal expression of impression4. 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.

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III. IMPLICATIONS FOR DIGITALThe 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 WebsitesBelow 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 line3. “Important Safety Information” headline treatment and specificity issues4. Risk information presentation issues

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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.

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 foldWhile the quantity of risk information provided equals the quantity of benefi t information on the page, its location presents concerns. In the May 2009 draft guidance, the FDA states: “In addition to appearing with or near benefi t presentations, risk information should appear as an

integral part of the piece, just as benefi t 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 benefi t 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 specifi cityThe “Important Safety Information” headline presents two specifi c 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 benefi t 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.

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9 See: http://blog.pharmexec.com/2009/06/25/building-a-better-brief-summary/ for more on recent FDA studies around this concept.

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 presentationOf 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 (benefi t) 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 colorC. Change in font color and size to smaller, lighter weightD. Text presented as large block9

E. Footer navigation and copyright information given equal weight

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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.

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 benefi t information

B. Branded BannersBranded banner advertisements fall into two main categories: 1. Animated Banners (SWFs and GIFs) 2. Rich Media

The fi rst 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 benefi t information should be comparably noticeable or conspicuous in promotional pieces, and audiences should be able to read both risk and benefi t information with similar ease... .” 10

Below are two wireframes of very standard pharmaceutical banner ad layouts:

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There is nothing inherently “wrong” with either layout. The potential issues arise with specifi c implementations.

For comparison, here are two wireframes of pharmaceutical ads currently in market that are representative of standard practices:

1. Treatment of risk informationThe tiny links to the “Prescribing Information” and ISI are potential issues here. Their proximity to the brand benefi ts is in line with the recommendations, but extremely tiny font size does signal that this information is less important than the large brand benefi ts above.

Action Item: Apply same or visually equal style to the ISI as the benefi t 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 benefi t 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 specifi c 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 fi rst 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”

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3. Framing of boxed warningThe framing of the boxed warning with “Prescribing Information” and the Medication Guide could minimize the impact of the boxed warning. There is specifi cally 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 specifi c 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 fi ctional example of this type of potentially misleading redirect ad:

1. Misleading URLPharma 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.

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Action Item:

Action Item:

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

D. Organic Search ListingsThe final area of consideration under the new draft guidance is organic search. The FDA has never offered official guidance on this channel, 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 issues, and actually improve the patient experience moving forward. Sometimes, the search engines will pull from body copy rather than from the description. 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/.

Bing.com“More

Information”

Yahoo! Search Listing

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IV. Risk Evaluation MatrixThe 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.

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Risk Tactic Issue Recommendation

M Branded Website

ISI placed in middle of utility navigation signals safety

information is of low importance

Separate out the ISI and PI links from the true utilities such as “send to a friend.” Consider placing in primary navigation

M Branded Website

ISI headline does not include brand name, which creates framing issue, as benefit

information generally includes brand nameInclude brand name with

“Important Safety Information” headline

H Branded Website

ISI font size and style are different from other content on page, signals lower

importance of safety information compared with other content

Match headline and body copy font size and styles in ISI and rest of page content

M Branded Website

Change in background color in ISI section could signal that page has ended and that the

rest of the information is unimportantIncorporate ISI as content on the page

– not part of the footer

H Branded Banner Ads

ISI font size and style are different from other content on page, signals lower

importance of safety information compared with other content

Keep font size of ISI links, at minimum, the same as smallest benefit information

M Branded Banner Ads

Static ISI does not provide safety information at a glance

Use auto-scrolling ISI or ensure that some risk information is visible without scrolling

M Branded Banner Ads

ISI headline does not include brand name, which creates framing issue, as benefit

information generally includes brand nameInclude brand name with “Important

Safety Information” headline

H Branded Banner Ads

Boxed warning presented in middle of list of items, which frames it with less important items and reduces impact

Place boxed warning at beginning or end of list

Digital Net Impression Risk Evaluation

continued...

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

V. ConclusionIn 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.

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Risk Tactic Issue Recommendation

H Unbranded Search Ads

Unbranded ad that clicks through to branded website is misleading Direct unbranded ads to unbranded websites

H Branded Search Ads

Branded ad includes product and benefits, but no fair balance

Either only use product with generic name and not benefits, or include risk12

LBranded Organic Search

Organic search listing does not contain any fair balance

Take active steps to have ISI link included in optional links and include word “risk” along

with benefits in descriptions that include benefit information

Digital Net Impression Risk Evaluation (cont'd)


APPENDIX: ELEMENTS OF NET IMPRESSION – A REFERENCE GUIDEThis 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 languageUse 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 informationThe 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 Example13: “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?

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15 Ibid, page 11, lines 365-366.

3. FramingRisk 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 comprehensivenessTreat 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. SignalsUsing 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

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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 informationRisk 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.

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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

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.

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New Transparency and New Trust: Bridging the Digital Divide in the FDA’s May 2009 Draft Guidance...

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Transcript of New Transparency and New Trust: Bridging the Digital Divide in the FDA’s May 2009 Draft Guidance...