Industry Strategies for Linking Disease Awareness Websites to Product Promotions

By Dale Cooke The US Food and Drug Administration (FDA) has been notoriously silent on the question of the appropriate use of hyperlinks in the context of brand promotion. Dating back to its 1996 hearings on the Internet, FDA has been asking when the use of hyperlinks is appropriate, and in the 2009 FDA hearings on social media and the Internet, the question was restated by FDA.1 However, guidance from the agency on this issue has not been forthcoming. In its absence, certain industry standards have evolved, and several enforcement letters have mentioned hyperlinks. This article looks at one type of hyperlink and presents industry strategies that have evolved in the absence of any FDA guidance. Specifically, this article examines the ways sponsors of prescription products link their disease awareness communication websites to product promotion websites. In a review of 20 disease awareness websites, half included an indirect linking path to a product promotion site. Before diving into the topic, it is important to clarify some terminology and note a caveat to the discussion. First, the two-part caveat. This article discusses 20 websites that have not been subject to FDA enforcement action and one that has received an enforcement action. As a general rule, the fact that some promotional materials have not been subject to an enforcement action does not guarantee FDA views those specific tactics as compliant. Famously, for several years, FDA took no enforcement action for the omission of risk information in Google text ads, and then issued 14 letters for such activity in a single day. In addition, simply avoiding issues FDA has previously cited does not itself ensure compliance with all agency requirements. However, it certainly is prudent to avoid making the same mistakes.

Terminology
Disease awareness communications are defined in FDA guidance as communications disseminated to consumers or healthcare practitioners that discuss a particular disease
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Image 1: Interstitial use is common in marketing of restricted products, such as alcohol. This sample interstitial requires the user to enter a birthdate before accessing the website.

or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device.2 Sponsors of prescription products frequently produce such materials to help consumers learn more about their conditions, to raise awareness about underdiagnosed conditions, and to provide supportive information that does not discuss use of a specific prescription product. FDAs guidance acknowledges that such activities can provide important health information.3 FDA also acknowledges that it does not have authority over the content of such communications.4 However, when materials that purport to be disease awareness communications actually are promoting prescription products, FDA does assume authority over these communications. Such activities can be the subject of FDA enforcement activity,5 and one such enforcement action even mentioned the inappropriate use of hyperlinks as one reason the piece was actually a product promotion and not a disease awareness communication.6

Separation
One means of ensuring disease awareness communications are distinct from product promotions, according to the FDA guidance, is to create separation between the communications. Separation can be achieved through physical and temporal distance and perceptual dissimilarity between the disease awareness communications and the product promotions.7 Hyperlinks (also referred to as links and hypertext) are a cornerstone of the Internet. Hyperlinks are the bits of code that take a visitor from one website to another. Text or images can be associated with a hyperlink. When users click their mouses (or touch displays on a device such as an iPad) on the text or image with a hyperlink, they are taken to the destination location. When the destination location is a different part of the same webpage, the link is known as an anchor link. A link can also take users to another page within the same website, or to a page on a completely different website. A hyperlink that takes visitors to another website can do so immediately or after an interstitial message appears. An interstitial message can have any text the site owner wants and typically requires users to take a certain action (such as click on the word continue or enter their birth date) before continuing to the destination location (see Image 1). The interstitial message itself can be a separate pop-up window, a page within the originating website or a

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Image 2: Sample showing multiple tabs (in red box) opened in the same web browser window.

separate layer that superimposes itself within the same tab and the same window as the originating website. Regardless of whether an interstitial is used, a hyperlink can take a user to a new website in two different ways: 1.  Open the new page in the same tab within the same windowfor the user, the destination page usually appears to replace the original webpage. 2.  Open the new page in a separate tab. All modern web browsers enable users to have multiple tabs open within the same window (as shown in Image 2).8 All browsers also enable users to open multiple windows simultaneously (as shown in Image 3).9

Image 3: Sample showing multiple windows opened in the same browser.

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Image 4: Image from material provided by FDA of cited material. Red box around the link added.

Linking From Disease Awareness Sites to Product Promotions

The industry practices discussed in the remainder of this article focus on the location of the hyperlinks on the originating webpage (if any), the use of interstitials, and the language used to notify site visitors that they are moving to a product promotion website. Note that it is assumed that the originating website is a disease awareness communication and is not a covert product promotion.10 For this article, we reviewed 20 disease awareness websites. The websites were selected because they were prominently featured in current direct-to-consumer (DTC) television campaigns, had been nominated for an industry award for excellence within the past three years, or represented a prevalent condition (e.g., diabetes) that was not otherwise included in the sample. The conditions covered included rare disease, chronic conditions, pain management, endocrine disorders and cancers. Six of the sponsoring companies were among the top 10 pharmaceutical companies as measured by 2012 pharmaceutical revenues.11 The others were mid-size and small companies; in one case, a firm with only one marketed product.

Use of Interstitials
The one FDA enforcement action that mentioned linking to a product promotion website from a purported disease awareness communication cited a direct link.12 It should be noted that this link was one of multiple elements cited by FDA as evidence that the disease awareness website was promoting a specific product; the link was not the sole factor that turned the disease awareness communication into a product promotion.13 It is not possible to recreate the exact circumstances based on the letter and the accompanying posted material. However, since no interstitial page was provided in the FDA sample
Table 1: Disease Awareness Survey
Summary of Disease Awareness Survey Included indirect link to product promotion Of those: Used an interstitial No interstitial 8/10 (80%) 2/10 (20%) (N=20) 10 (50%)

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Image 5: Sample image showing path from disease awareness site home page (on left) with callout in the navigation (highlighted in red box) to a prescription treatment with interstitial (center) and brand site (on right). This indirect linking path was used by four of the sites in the survey.

of the material, it would appear that the page in question had a direct link to the product promotion page (See Image 4). Although FDA did not provide a definition of direct link, the absence of an interstitial page in the material provided suggests that the product promotion website opened in the same tab, replacing the originating disease awareness website, without any intervening interstitial. Interstitials do appear to be a current industry standard. In the review described above, eight of the 10 disease awareness sites that included an indirect path to a product promotion website used an interstitial. The remaining websites that provided an indirect path to a product promotion page opened the product promotion page in a separate tab within the same browser window as the disease awareness communication and kept the disease awareness website open in a separate tab, thereby separating the two communications. Half of the disease awareness websites in this review did not include any means to navigate to a product promotion, unless the site visitor first followed the link to the sponsors corporate site and then found a page listing the products manufactured by the sponsor.14 Further details of the indirect linking path and its variety are presented in Table 1. All of the websites examined included prominent links to the corporate website of the sponsoring company. Interestingly, in one case, the About Us link did not go to the corporate home page but instead took site visitors to a separate page that discussed the products the company had on the market, including a discussion of the product that was approved for the condition discussed in the disease awareness website. This also was the only link from the disease awareness website to any discussion of a specific product by the sponsor.

Image 6: Sample image showing the path from a disease awareness site interior page (on left). A sentence on the page (highlighted in red box) links to a prescription treatment page with an interstitial (center) and a brand site (on right). This indirect linking path was used by three sites in the survey. regulatoryfocus.org October 2013 5

Table 2: Indirect Link Location

Indirect Link Location (n=10) Primary navigation Treatment locator tool Body copy on a page Callout on home page 4 (40%) 2 (20%) 3 (30%) 1 (10%)

Placement of the Link

Of the websites that included a navigation path from the disease awareness website to a product promotion website, 40% placed the link in the primary site navigation (as shown in Image 5). The language used on the links typically made clear that it would lead to a product promotion, even before any interstitial appeared. Language such as Ready to learn about a prescription for [condition] or Treatment options commonly was used on the disease awareness websites. In three cases where an indirect link was provided, it was buried in the copy on a page within the site (see Table 2). The copy included phrasing along the lines of, To learn more about a treatment option, click here. In all three cases, the paragraph where a treatment option was discussed was located on an interior page (i.e., not the home page) of the disease awareness website. See Image 6 for an illustration of this linking pathway. Two websites used treatment locator tools, which permit site visitors to find a specialty physician in their area, to take users from the disease awareness communication to the product promotion website, where they can search for a physician. In neither case was there any mention that using the tool would take the visitor to a product promotion website, nor was any interstitial used. Both websites opened the results page in a different tab from the tab with the original disease awareness website.15 See Image 7 for an illustration of this pathway.

Image 7: Sample image showing the path from a disease awareness page (top left) with a physician locator tool (highlighted in red box). On two disease awareness sites in the survey, this type of tool opens a new tab with the physician locator tool on a product promotion page. regulatoryfocus.org October 2013 6

Conclusion
The survey showed that, in the absence of FDA guidance, industry has adopted a wide variety of approaches for linking disease awareness websites to product promotional websites. Within that variety, certain industry standards have taken hold. No one in the survey included the type of direct link that FDA has cited in enforcement action, and companies would be wise to avoid doing so. The use of interstitials also has become standard among sites that provide an indirect link from a disease awareness site to a product promotion site. There was, however, far less consistency about the placement of the indirect link within the disease awareness website, with a wide variety of locations and prominence being implemented. Absent further FDA enforcement or guidance, it is likely this variety will continue as sponsors struggle with the question of how to implement the separation that FDA recommends on a medium that is inherently about connections.
References 1. On the 1996 FDA hearings, see the transcripts provided on the FDA website at http://www.fda.gov/AboutFDA/ CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm175775.htm. Accessed 13 October 2013. For the 2009 FDA hearings, see the FDA website at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ ucm184250.htm. Accessed 13 October 2013. 2. Draft Guidance for Industry: Help-Seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firm. FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM070068.pdf. 3. Ibid. p. 1. 4. Ibid. p. 1. 5. Driscoll J. FDA Requirements for Prescription Drug Promotion. Regulatory Affairs Professionals Society. Rockville, MD. 2013. See pp. 29-30 for a sample list of such activity. 6. FDA Warning Letter. Gleevec/April 2010. FDA website. http://www.fda.gov/ Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm259229.htm. Accessed 13 September 2013. 7. Disease Awareness guidance. Op. cit. p. 7. 8. See http://en.wikipedia.org/wiki/Web_browser for more on web browsers, windows and tabs. Accessed 14 August 2013. 9. Owners of a website can force a link to open in a new tab, rather than in the original tab. Owners of a website cannot control whether the new tab opens in the same window (as shown in Image 2) or whether the site opens in a separate window (as shown in Image 3). Web browser settings that are controlled by the user determine which of these two options occur. 10. Op.cit 7 for additional discussion about the ways that FDA recommends disease awareness communications be distinguished from product promotion. 11. Top Pharma Companies by 2012 Revenues. Fierce Pharma website. http://www.fiercepharma.com/special-reports/toppharma-companies-2012-revenues. Accessed 14 August 2013. 12. Op. cit. p. 4. 13. Ibid. 14. It is worth emphasizing that because links are central to the Internet, it is almost always possible to get from any one website to another website. The strategies discussed in this article focus on ways of creating separation between disease awareness communications and product promotion websites. 15. As mentioned in reference 9, the owner of the website can force a link to take the site visitor to a new tab, but whether that tab opens in the same window or a different window as the original tab depends on the individuals browser settings, which are outside the site sponsors control. About the Author Dale Cooke is the head of regulatory for Digitas Health. He helps companies use 21st century technology to connect with todays healthcare consumers and professionals while ensuring compliance with FDA regulations written in the 1960s. He can be reached at Dale.Cooke@digitashealth.com. Cite as: Cooke, D. Industry Strategies for Linking Disease Awareness Websites to Product Promotions. Regulatory Focus. October 2013. Regulatory Affairs Professionals Society.

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