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  • 1. New Transparency and New Trust:Bridging the Digital Divide in the FDA’s May 2009Draft Guidance on Presenting Risk Information inPrescription 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 RGB (screen match)
  • 2. I. INTRODUCTIONIn May 2009, the FDA released new draft guidance for presenting risk information in prescription drug andmedical device promotion. This new guidance covers both advertisements and promotional labeling fordrugs.1The FDA makes it clear that this new guidance is intended to cover broadcast, print, and Web; however, whileit highlights many implications for print and broadcast, it offers only one example for the Web. Consideringthe April 2009 release of 14 warning letters in a single day to pharmaceutical companies in regard to theirpay-per-click (PPC) search engine advertisements, it is not necessarily helpful to e-marketers that the FDAoffered only a single example for Web promotions. While much of the new guidance can effectively beapplied to digital media, the FDA has still left much to interpretation.Key Takeaways1. May 2009 FDA guidance officially covers digital, but few specific examples are provided2. “Net Impression” and “Reasonable Consumer” standards now have greater prominence3. Risk information must be treated equally with benefit information in the digital environment4. Pharmaceutical marketers need to establish in-house guidelines for digital risk presentation5. Pharma marketers need to embrace a more transparent approach to risk informationThe core issue for the FDA and for marketers is one of transparency. The FDA’s goal is to ensure thatconsumers receive a “balanced presentation of both the benefits and the risks associated with theadvertised” products.2 As marketers, our objective is not only to present products in the most compellingand relevant way possible, but also to empower patients, caregivers, and healthcare professionals withinformation to make better choices about their healthcare options. Regulation requires us to present fairbalance about the prescription medications we are promoting. The May 2009 draft guidance is signaling thatwe must find a new approach focused on a more transparent presentation of both the benefits and risks.This aligns with what consumers say they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 fearsaround 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.html2 “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.html3 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-ageNew Transparency and New Trust 1
  • 3. With this in mind, RTCRM believes that the most important next step for pharmaceutical companies isto collaborate with regulatory teams to develop relevant, specific guidelines that reflect the spirit of theFDA draft guidance document. The digital environment is unique and too complex to attempt to useprint formats as the standard. Even more important, based on this new guidance, RTCRM recommendsimplementing 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 andpromotional materials that will be fully compliant with the May 2009 draft guidance. This will also help us allachieve our common goal of empowering the public to make better, more educated healthcare decisions.II. NET IMPRESSION AND THE REASONABLE CONSUMERThe new materials issued by the FDA are not new regulations, but rather guidance that amounts toadditional clarification on the regulations and how to applythem. The FDA is now offering more specific informationaround what “fair balance” really means and how it will bejudged. Fair balance will be judged against two standards: Reasonable Consumer1) how a marketing piece is interpreted by a “reasonable Standardconsumer” and 2) the Net Impression that the marketing 4 “The reasonable consumer standardpiece creates. more accurately reflects FDA’s belief that consumers are active partnersThe Reasonable Consumer Standard. in their own health care who behaveWhile not new, the May 2009 guidance brings renewed in health promoting ways whenemphasis to the “reasonable consumer standard” as defined they are given accurate healthby 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, 2002average target as the “reasonable consumer.” When evaluatinghow a reasonable consumer may interpret marketing material,they state: “To be considered reasonable, the interpretation orreaction does not have to be the only one. When a seller’s representation conveys more than one meaning toreasonable consumers, one of which is false, the seller is liable for the misleading interpretation.”64 “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.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. Content2. FormattingThe FDA breaks these two areas down into 18 separateelements. How each of these elements creates the NetImpression, especially in a digital environment, is what Net Impression:needs to be explored. Is the Net Impression the entire path “the message communicated by allthe 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 thefair balance and that is the end. By nature, digital requires a From: FDA Draft Guidance for Industry: Presenting Risk Information in Prescriptionconsumer to actively navigate multiple pieces of content in Drug and Medical Device Promotionone “experience” or sitting.Example: Search engine to landing page could be a NetImpression, email to website could be a Net Impression, awebsite-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 NetImpression of a single webpage or ad.The foundation of the Net Impression standard is the “reasonable consumer.” The emphasis on this standardrequires pharmaceutical companies to firmly establish and document who the target audience of alladvertising and promotional materials is. Establishing who the target audience is (or audiences are) for thepromotions will also allow pharmaceutical companies to test for fair balance before submitting a piece forFDA “Date of First Use” (DOFU) approval. This documentation will also be of assistance in documentingempirical evidence that the risks and benefits were understood by the target audience, should they receiveany 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 PersonasIt can be difficult when reviewing materials to see through the eyes of others, which is why marketersoften use a tool called “personas.” The use of a persona can set a consistent scene for all reviewers to judgeappropriateness of language and overall Net Impression of benefit and risk information. Elements of a personashould 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• TechnographicsB. Net Impression TestingTesting for Net Impression need not be an expensive or expansive proposition in a digital context. Theapproaches used for usability testing can easily be applied to this as well. This includes the smaller sample sizesused in usability testing. Quantitative studies have shown that within any segment, a maximum of 10-15 peopleare 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 withusability testing for further efficiency.7 Krug, Steve. Dont 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 DIGITALThe FDA provided many clear examples for print and broadcast advertising and promotions, but only oneexample for digital. Based on the draft guidance, the largest changes may need to be in how brands approachdigital marketing. The following is not a comprehensive list of all possible digital implementations, but focuseson the ones least clear from the draft guidance. For example, we have not included online video, because thebroadcast 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 notintended 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 compositeof five major pharmaceutical websites currently in market. On this fictitious homepage there are at least fourmajor 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 issuesNew 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 draftguidance. The primary concern is that grouping the ISI with the utilities signals that this is useful, butnot important, information. There is also a hierarchy issue, as many times the ISI is listed in the middle ofseveral 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 benefit information on the page, itslocation 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.”8By placing all risk information well below the fold, it is reasonable to assume that the average consumermay not be exposed to it. However, this is debatable. As Internet and even mobile penetration increases, itbecomes less and less likely that a reasonable consumer does not know to scroll. Usability testing outlinedin 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 prescriptionbrands could explore. Many “black box” brands are including the beginning text of their “ImportantSafety Information” at the top of the page, with a link to the rest at the bottom. This ensures that at leastpart of the fair balance is always well above the fold and clearly provides both benefit and risk in any NetImpression. Action Item: Ensure some risk information is visible above the fold on average monitor resolution3. “Important Safety Information” headline treatment and specificityThe “Important Safety Information” headline presents two specific concerns around font size and style andframing.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 colorand size.The second issue with the standard ISI headline is what the FDA calls “framing.” Under this new guidance the ISIheadline 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 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 sectionat 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 thanthe main body (benefit) information. Often websites will provide a visual signal that the content has endedthrough:A. Visual indicator that page is doneB. Change in background colorC. Change in font color and size to smaller, lighter weightD. Text presented as large block9E. Footer navigation and copyright information given equal weight9 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 averageconsumer to be a part of the content, not separate information, to be considered fair and balanced. Usingthese types of devices minimizes the importance of the content and could lead the FDA to determine thatthe site is misleading.In addition to signaling that the “real content” has ended through visual cues, the content of the risk area isgenerally presented as a wall of text. Based on the new guidance, the content should be presented as corecontent 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 informationB. Branded BannersBranded banner advertisements fall into two main categories: 1. Animated Banners (SWFs and GIFs) 2. Rich MediaThe first is a simple animated banner with little to no interactivity. The second is only limited by theimagination and budget, and can provide deep, rich functionality. Finding the space for fair balance in smallbanner advertisements can be a challenge, and the new guidance will only increase the challenge. Due to theApril 2009 warning letters raising questions about the validity of the “one-click” rule for fair balance, we haveseen a decline in standard banner ads that do not allow at least minimal interactivity to surface fair balancewithin the ad.The key issues for fair balance in banner ads, under the new guidance, are similar to those impacting brandedwebsites. 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... .” 10Below 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 specificimplementations.For comparison, here are two wireframes of pharmaceutical ads currently in market that are representative ofstandard practices:1. Treatment of risk informationThe tiny links to the “Prescribing Information” and ISI are potential issues here. Their proximity to the brandbenefits is in line with the recommendations, but extremely tiny font size does signal that this information isless important than the large brand benefits above. Action Item: Apply same or visually equal style to the ISI as the benefit information2. Scrolling “Important Safety Information”Both ad formats utilize the scrolling “Important Safety Information.” The issue with this implementation isthat, in the end, it may actually minimize the importance of the risks, as the lead copy in each only referencesthe 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 lessimportant than the benefit information.It is important to note that the scrolling ISI is somewhat preferable to an on-click ISI. The scrolling ISI doeselevate the importance over the small button that simply says “Important Safety Information.” The specificissue here is that the allowable space for the ISI is too small to actually read the ISI or see any of the safetyinformation without scrolling. Alternative versions of the scrolling ISI, which expose the majority of the ISI atfirst glance and then are automatically minimized for the viewer, with an option to see on-click, are more in linewith 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 warningThe framing of the boxed warning with “Prescribing Information” and the Medication Guide could minimizethe impact of the boxed warning. There is specifically a hierarchy issue, with it being in the middle of a list ofother items. Action Item: Display true domain names in all PPC adsThe net takeaway for branded banner ads, both simple and rich media, is that the fair balance needs to be easilyconsumed and understood by the average target viewer. This is easily achieved with rich media ads, and basedon 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 inApril 2009. These letters raised new questions about the viability of this type of branded advertising forpharmaceutical brands. The core issue was the lack of fair balance. Unfortunately, the FDA has not providedspecific 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 bestoff avoiding branded search advertisements, other than reminder ads.Here is a fictional 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. Allother 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 clickthrough to a branded website from either the copy or the domain name. Action Item: Display true domain names in all PPC adsIn May 2009, RTCRM issued a detailed white paper about the impact of the 14 FDA warning letters on searchengine marketing, titled “An Eye on Google: Re-Engaging with Digital Marketing in Response to Recent FDAWarnings,” which can be downloaded at www.rtcrm.com/whitepapers.New Transparency and New Trust 10
  • 12. D. Organic Search ListingsThe final area of consideration under the newdraft guidance is organic search. The FDA hasnever offered official guidance on this channel, Yahoo! Search Listingbut it could be covered under the new draftguidance.While not all elements of organic searchdisplay are controlled by the brand, RTCRMhighly recommends close vetting of titles anddescriptions, which are the controllable elementsof organic search. With organic search, charactercounts, unlike with paid search, are much longerand 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 carefullycoding their websites. Marketers can also always use FDA-compliant titles and descriptions, and then the entireorganic listing would provide the proper user experience based on recent FDA guidance. More information onGoogle 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/whitepapersNew Transparency and New Trust 11
  • 13. IV. Risk Evaluation MatrixThe FDA draft guidance outlines many elements that make up fair balance. There are few elements that ontheir own are a high risk. It is the combination that creates the Net Impression. If your site has a high number ofmedium-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 (contd) 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 informationV. ConclusionIn the end, each pharmaceutical company will need to work with its legal team to make any final decisionsregarding digital tactics and how to effectively deliver against the true intention of the latest FDA guidancedocumentation.The new guidance does provide additional clarity as to what is and is not acceptable in the realm of “fairbalance” in a digital environment, but it also opens new questions. What is clear is that marketers, both brandsand agencies, will need to create new ways of establishing, testing, and documenting what is reasonable to theaverage 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 tomarketers to highlight the downsides of a product, engaging in a new sense of consumer-centric transparencyis a must to be compliant with the draft guidance on risk presentation. Consumers may even appreciatethe 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 toensure 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/whitepapersNew Transparency and New Trust 13
  • 15. 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 draftguidance on presenting risk information. This guide is not comprehensive, but rather details specific elementsthat have a large impact on Net Impression in a digital environment.1. Target-appropriate languageUse accurate language that consumers will easily understandGuideline: Avoid scientific language in consumer materialsAppropriate language is one of the easier standards to comply with, as most pharmaceutical companies havealready been applying this for some time. Target audiences are generally determined by the population amedication 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 helpmarketers create better communications, they can also serve as a point of reference for MedReg in evaluatingwhether 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 informationGuideline: In video, the most important risks should be presented at the beginning or the end. In text, the mostimportant risks should be presented firstThere are two issues to consider with hierarchy of information, both having to do with how people processinformation. The first is simply that people remember information at the beginning or end better than whatwas presented in the middle. The second is that the order of the information may lead people to groupinformation 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 drowsinessand nausea.”The order of this information may lead a reader to conclude that the nausea and drowsiness occur only whenpeople 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. FramingRisk and benefits must be specifically stated and include statements that would minimize the severity of a riskGuideline: Be specific and use the brand name when describing both risks and benefitsThe FDA is clearly indicating that pharmaceutical companies must be specific when discussing risks, toavoid minimizing the risk to the average consumer. The first and simpler guidance is that the brand namebe used both when benefits and risks are mentioned. The second and more subjective guidance is aroundspecificity of risks.FDA Example14 : A drug’s package insert contains a boxed warning about the risk of life-threatening feversassociated 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 contentGuideline: 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 betreated equally with the benefit information. This includes: • Have an equal number of statements about risks and benefits, equal level of detail about each5. SignalsUsing writing devices to emphasize or call attention to contentGuideline: Use consistent emphasis on all headers and copy, whether involving benefit or riskThe use of signals is an inherent part of most webpages. HTML code is built around content hierarchy and theuse of semantic code has been a best practice for some time. The HTML tag “H1” indicates the most important14 “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 shouldbe 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 SafetyInformation” headline should be 12 pixels. The same goes for the body copy in the benefits area and the risksarea; they should be the same font size. These signals are especially important in a Web environment, wherestudies have shown that people tend to scan the pages instead of reading them. This also applies to the use ofvoiceovers 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 pieceThe new guidance around hierarchy of information may require the most changes for brand websites. TheFDA states that “...risk information should not just be presented in one location in a piece, but should, likebenefit information, appear as an integral part of the piece.” 16This is a change from current practices on most brand websites. The standard industry approach has been toplace 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 ofthe 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.New Transparency and New Trust 16
  • 18. About RTC Relationship MarketingRTC Relationship Marketing (RTCRM) is a full-service direct marketing and relationship marketing agencybased in Washington, D.C., in the heart of Georgetown, with offices in New York and Chicago. RTCRM boastsmore than 40 years’ worth of innovative, targeted solutions that grow its clients’ brands and help them forgelasting, valuable relationships with their customers. What distinguishes RTCRM is its unique ability to analyzedata 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 WarnerCable. RTCRM’s innovative campaigns have won numerous advertising and direct marketing awards. RTCRMis 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, NWSuite 200Washington, DC 20007202.625.2111www.rtcrm.com/whitepapersNew Transparency and New Trust 17