Industry Standards for Linking Disease Awareness Websites to Product Promotion

7/27/2019 Industry Standards for Linking Disease Awareness Websites to Product Promotion

1/7October 2013regulatoryfocus.org

By Dale Cooke

The US Food and Drug Administration (FDA) has been notoriously silent on the question

o the appropriate use o hyperlinks in the context o brand promotion. Dating back to its1996 hearings on the Internet, FDA has been asking when the use o hyperlinks is appro-

priate, and in the 2009 FDA hearings on social media and the Internet, the question was

restated by FDA.1 However, guidance rom the agency on this issue has not been or th-

coming. In its absence, certain industry standards have evolved, and several enorcement

letters have mentioned hyperlinks. This article looks at one type o hyperlink and presents

industry strategies that have evolved in the absence o any FDA guidance. Specifcally, this

article examines the ways sponsors o prescription products link their disease awareness

communication websites to product promotion websites. In a review o 20 disease aware-

ness websites, hal included an indirect linking path to a product promotion site.

Beore diving into the topic, it is important to clariy 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 enorcement action and one that has received an enorcement

action. As a general rule, the act that some promotional materials have not been subject to

an enorcement action does not guarantee FDA views those specifc tactics as compliant.

Famously, or several years, FDA took no enorcement action or the omission o risk inor-

mation in Google text ads, and then issued 14 letters or such activity in a single day.

In addition, simply avoiding issues FDA has previously cited does not itsel ensure

compliance with all agency requirements. However, it certainly is prudent to avoid making

the same mistakes.

Terminology

Disease awareness communications are defned in FDA guidance as communications

disseminated to consumers or healthcare practitioners that discuss a particular disease

Industry Strategies for Linking Disease

Awareness Websites to Product Promotions



or health condition, but do not mention any specifc drug or device or make any represen-

tation or suggestion concerning a particular drug or device.2 Sponsors o prescription

products requently produce such materials to help consumers learn more about their con

ditions, to raise awareness about underdiagnosed conditions, and to provide supportive

inormation that does not discuss use o a specifc prescription product. FDAs guidance

acknowledges that such activities can provide important health inormation.3 FDA also

acknowledges that it does not have authority over the content o such communications.4

However, when materials that purport to be disease awareness communications actually

are promoting prescription products, FDA does assume authority over these communi-

cations. Such activities can be the subject o FDA enorcement activity,5 and one suchenorcement action even mentioned the inappropriate use o hyperlinks as one reason the

piece was actually a product promotion and not a disease awareness communication.6

Separation

One means o ensuring disease awareness communications are distinct rom product

promotions, according to the FDA guidance, is to create separation between the com-

munications. Separation can be achieved through physical and temporal distance and

perceptual dissimilarity between the disease awareness communications and the product

promotions.7

Hyperlinks (also reerred to as links and hypertext) are a cornerstone o the

Internet. Hyperlinks are the bits o code that take a visitor rom one website to another.

Text or images can be associated with a hyperlink. When users click their mouses (ortouch 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 dierent part o

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 dierent website. A

hyperlink that takes visitors to another website can do so immediately or ater an intersti

tial 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) beore continuing to the destination location (see Image 1). The interstitial mes-

sage itsel can be a separate pop-up window, a page within the originating website or a

Image 1: Interstitial use is common in marketing o restricted products, such as alcohol. This sample interstitial

requires the user to enter a birthdate beore accessing the website.



separate layer that superimposes itsel within the same tab and the same window as the

originating website.

Regardless o whether an interstitial is used, a hyperlink can take a user to a new

website in two dierent ways:

1. Open the new page in the same tab within the same windowor 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 2: Sample showing multiple tabs (in red box) opened in the same web browser window.

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



Linking From Disease Awareness Sites to Product Promotions

The industry practices discussed in the remainder o this article ocus on the location

o the hyperlinks on the originating webpage (i any), the use o interstitials, and the lan-

guage used to notiy site visitors that they are moving to a product promotion website.

Note that it is assumed that the originating website is a disease awareness communica-

tion 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 eatured in current direct-to-consumer (DTC)

television campaigns, had been nominated or an industry award or 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, chronicconditions, pain management, endocrine disorders and cancers. Six o 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

frm with only one marketed product.

Use of Interstitials

The one FDA enorcement action that mentioned linking to a product promotion website

rom a purpor ted disease awareness communication cited a direct link.12 It should

be noted that this link was one o multiple elements cited by FDA as evidence that the

disease awareness website was promoting a specifc product; the link was not the sole

actor 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 accompany-ing posted material. However, since no interstitial page was provided in the FDA sample

Image 4: Image rom material provided by FDA o cited material. Red box around the link added.

Table 1: Disease Awareness Survey

Summary of Disease Awareness Survey (N=20)

Included indirect link to product promotion 10 (50%)

O those:

Used an interstitial 8/10 (80%)

No interstitial 2/10 (20%)



o 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 defnition o direct link,

the absence o 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 o the 10 disease awareness sites that included an indirect path to a prod-

uct 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 sepa-

rate 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.

Hal o the disease awareness websites in this review did not include any means to nav-

igate to a product promotion, unless the site visitor frst ollowed the link to the sponsors

corporate site and then ound a page listing the products manuactured by the sponsor.14

Further details o the indirect linking path and its variety are presented inTable 1

.All o the websites examined included prominent links to the corporate website o the

sponsoring company. Interestingly, in one case, the About Us link did not go to the corpo-

rate home page but instead took site visitors to a separate page that discussed the products

the company had on the market, including a discussion o the product that was approved or

the condition discussed in the disease awareness website. This also was the only link rom

the disease awareness website to any discussion o a specifc product by the sponsor.

Image 5: Sample image showing path rom disease awareness site home page (on let) with callout in the navi-

gation (highlighted in red box) to a prescription treatment with interstitial (center) and brand site (on right). This

indirect linking path was used by our o the sites in the survey.

Image 6: Sample image showing the path rom a disease awareness site interior page (on let). 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.



Placement of the Link

O the websites that included a navigation path rom 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 prod-

uct promotion, even beore any interstitial appeared. Language such as Ready to learn

about a prescription or [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 o, 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) o the dis-

ease awareness website. See Image 6 or an illustration o this linking pathway.

Two websites used treatment locator tools, which permit site visitors to fnd a spe-

cialty physician in their area, to take users rom the disease awareness communication

to the product promotion website, where they can search or 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 dier-

ent tab rom the tab with the original disease awareness website.15 See Image 7 or an

illustration o this pathway.

Table 2: Indirect Link Location

Indirect Link Location (n=10)

Primary navigation 4 (40%)

Treatment locator tool 2 (20%)

Body copy on a page 3 (30%)

Callout on home page 1 (10%)

Image 7: Sample image showing the path rom a disease awareness page (top let) with a physician locator tool

(highlighted in red box). On two disease awareness sites in the survey, this type o tool opens a new tab with the

physician locator tool on a product promotion page.



Conclusion

The survey showed that, in the absence o FDA guidance, industry has adopted a wide

variety o approaches or linking disease awareness websites to product promotional web-

sites. Within that variety, certain industry standards have taken hold. No one in the survey

included the type o direct link that FDA has cited in enorcement action, and companies

would be wise to avoid doing so. The use o interstitials also has become standard among

sites that provide an indirect link rom a disease awareness site to a product promotion

site. There was, however, ar less consistency about the placement o the indirect link

within the disease awareness website, with a wide variety o locations and prominence

being implemented. Absent urther FDA enorcement or guidance, it is likely this variety

will continue as sponsors struggle with the question o 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.da.gov/AboutFDA/

CentersOfces/OfceoMedicalProductsandTobacco/CDER/ucm175775.htm. Accessed 13 October 2013. For the 2009 FDA

hearings, see the FDA website at http://www.da.gov/AboutFDA/CentersOfces/OfceoMedicalProductsandTobacco/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.da.gov/downloads/Drugs/GuidanceComplianceRegulatoryInormation/Guidances/

UCM070068.pd.

3. Ibid. p. 1.

4. Ibid. p. 1.

5. Driscoll J. FDA Requirements for Prescription Drug Promotion. Regulatory Aairs Proessionals Society. Rockville, MD. 2013.See pp. 29-30 or a sample list o such activity.

6. FDA Warning Letter. Gleevec/April 2010. FDA website. http://www.da.gov/

Drugs/GuidanceComplianceRegulatoryInormation/EnorcementActivitiesbyFDA/

WarningLettersandNoticeoViolationLetterstoPharmaceuticalCompanies/ucm259229.htm. Accessed 13 September 2013.

7. Disease Awareness guidance. Op. cit. p. 7.

8. See http://en.wikipedia.org/wiki/Web_browser or more on web browsers, windows and tabs. Accessed 14 August 2013.

9. Owners o a website can orce a link to open in a new tab, rather than in the original tab. Owners o a website cannot contro

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 o these two options occur.

10. Op.cit 7 or additional discussion about the ways that FDA recommends disease awareness communications be distin-

guished rom product promotion.

11. Top Pharma Companies by 2012 Revenues. Fierce Pharma website. http://www.fercepharma.com/special-reports/top-

pharma-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 rom any one

website to another website. The strategies discussed in this article ocus on ways o creating separation between disease

awareness communications and product promotion websites.15. As mentioned in reerence 9, the owner o the website can orce a link to take the site visitor to a new tab, but whether that

tab opens in the same window or a dierent 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 o regulatory or Digitas Health. He helps companies use 21st century technology to connect with

todays healthcare consumers and proessionals while ensuring compliance with FDA regulations written in the 1960s. He can be

reached at [email protected].

Cite as: Cooke, D. Industry Strategies or Linking Disease Awareness Websites to Product Promotions. Regulatory Focus.

October 2013. Regulatory Aairs Proessionals Society.

2013 by the Regulatory Aairs Proessionals Society. All rights reserved.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm175775.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm175775.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184250.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184250.htmhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070068.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070068.pdfhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm259229.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm259229.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm259229.htmhttp://en.wikipedia.org/wiki/Web_browserhttp://www.fiercepharma.com/special-reports/top-pharma-companies-2012-revenueshttp://www.fiercepharma.com/special-reports/top-pharma-companies-2012-revenueshttp://www.fiercepharma.com/special-reports/top-pharma-companies-2012-revenueshttp://www.fiercepharma.com/special-reports/top-pharma-companies-2012-revenueshttp://en.wikipedia.org/wiki/Web_browserhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm259229.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm259229.htmhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm259229.htmhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070068.pdfhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070068.pdfhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184250.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm184250.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm175775.htmhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm175775.htm

Documents

Industry Standards for Linking Disease Awareness Websites to Product Promotion