FDA Separates the Medium from the Message – August 2010

Executive Summary • The FDA has issued a letter targeting the misuse of social media sharing

widgets, specifically indicating that how they were used contravened FDA regulations

• This has clarified the FDA’s stance on social media sharing and provided guide posts about how to use it within regulations

• The implications for Pharma are that they need to include Regulatory and Legal on reviews of “hidden” text such as share widgets and search descriptions

The Event

On August 4, 2010 the FDA posted a letter1 to Novartis about its use of a "Facebook share" social media widget. The letter was triggered by the use of four "share" icons on the website:

As of this writing2 the icons have been removed from the website.3

The Core Issue

The FDA found that the shared text, which varied throughout the site, had the following issues:

• Described indication but omitted risk information • Broadened the product indication • Overstatement of the product efficacy • The shared text was not submitted to the FDA for review as part of the

website

Important When a share widget is used, the marketer has the option to inject some messaging into the user’s news feed. On Facebook (but not the other channels) this content is not editable by the user, and so, constitutes messaging provided and owned by the pharma company.

1 Direct link to the FDA letter (contact your Klick representative if you do not have an electronic version):

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM221325.pdf 2 2:30PM on Thursday, August 5, 2010 3 We were able to recreate the examples by using Google’s cached version of the website.

Examples

Here is what the Facebook share looked like when it was active:4

The information in the red box was injected into the user’s Facebook posting by the share tool. Note that the user cannot edit this information, which was explicitly called out in the FDA letter.

FDA Quote “By failing to disclose any risk information for Tasigna, the shared content misleadingly suggests that Tasigna is safer than has been demonstrated by substantial evidence or substantial clinical experience. This omission of risk information is particularly concerning given the fact that Tasigna has a Boxed Warning and a REMS program.”

Meta Data

The FDA letter is explicit in its concern over the pushing of content, which the user cannot edit, through the Facebook channel. This content, which is not visible on the website until someone engages the share function, is often called Meta Data.5

Note that your website probably has meta data in it right now. The “meta” tag for a page description is often used to position the content more accurately in Google search results.6

4 Note that the FDA letter was initiated under the August, 2009 approved PI, the indication changed in June, 2010

so the share text will not exactly match the initial text that the FDA complained about. That said, all issues expressed in the warning letter remained valid at the time of publishing.

5 Technically, this is not a correct usage of the term “meta data” (data that describes data) but the HTML tag used is <meta> so it gets the name in the vernacular.

6 See the Klick document, A Pharma Marketer’s Guide: Applying FDA Regulations to Online Marketing. Available at: http://www.klick.com/pharma/fda/signup/

Content injected into Facebook post by

share tool “meta data”

One of the organic Google search results for the word “Tasigna” is the corporate branded sites (global and US).

Global

The Meta tag that created this description in Google is:

<meta Name = "description" Content = "Tasigna (nilotinib) is a treatment of

Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults resistant or intolerant to Glivec."

/>

US

<meta Name = "description" Content = "Tasigna (nilotinib) 150-mg and 200-mg

capsules from Novartis is a treatment for Ph+ Chronic Myeloid Leukemia in newly diagnosed adult patients in chronic phase or patients in chronic or accelerated phase who are resistant to Gleevec."

/> These search listings in and of themselves may be in violation of FDA regulations in that they contain the indication but not fair balance. However, the FDA has made no moves to date that indicate that organic search results, which are compiled by a 3rd party (in this case Google), are held to the regulations.

This may hinge on the impression that the content is not owned or controlled by the pharma company. Note that the provision of descriptions to Google’s search engine could be interpreted as analogous to provision of link text to social media sharing tools, so this is a topic to watch.

Other Sharing Platforms The Tasigna website also used other platforms for sharing, and all of these look like they contravene at least one of the FDA regulations.

Delicious – In Violation

The Title field here is pre-populated with an expanded indication statement, but there is no fair balance information.

Digg – In Violation

Both the Title and the Description fields contain indication information (though at least it doesn’t look like an expansion of the indication), but there is no fair balance information.

Twitter – URL Only

The twitter implementation does not include any indication or efficacy information so this differs from the examples provided above.

What it Means Overall, this is positive news for pharma marketers in that it reinforces and clarifies three things:

1. The FDA has no particular quarrel with social media as a channel,

2. The FDA is not backing down from it's fair balance stance that disallows one-click access to the information, and,

3. There is no such thing as "tacit acceptance" with the FDA.

So the message is clear and consistent: The rules are being strictly interpreted across all new channels, and will continue to be when the (nearly) inevitable letters come out for some violations of other channels, such as mobile apps as one example.7

Using Social Media The usage of Social Media is well within the channel-agnostic FDA regulations. The key is to find a way of using it that provides value to your customers while not overstepping the regulations.

Our recommendations on how to stay on the right side of the FDA regulations:

• Do not stop planning social media initiatives. It is less of an unknown today than it was before this letter was issued.

• Ensure all “meta data” is sent through Regulatory review along with the other, surrounding material. This information may not be seen in the same way as the surrounding material, but it is seen, and needs to be vetted.

• Write most Social Media sharing text in a “reminder ad” format (when permissible) and forego the inclusion of indication or efficacy. This may dilute the impact somewhat, but you can rely on the consumer / patient to add some surrounding context.

Our recommendations on using Social Media:

To get the consumer / patient to share and add content, there needs to be a compelling reason.

• Ensure that there is a reason to share. Users will share items that they think others in their network will care about. For a cancer patient, this might be survival rates, for an asthma sufferer, it might be additional techniques for reducing environmental irritants.

7 The FDA has signaled that it is watching the mobile app space many times over the years

http://mobihealthnews.com/6726/washington-signals-possible-fda-regulation-of-mhealth/

For More Information For more information on topics like these, get our guide: Applying FDA Regulations to Online Marketing. You can download this guide for FREE at the following link:

http://www.klick.com/pharma/fda/signup/

To connect with us, visit or website ( klickpharma.com ) or call us at 1 877 885 9957.

ABOUTKLICKPHARMAKlick Pharma is a full-service digital marketing agency that specializes in the healthcare and pharmaceutical sector. With a focus on measurable results, Klick Pharma’s talented subject matter experts create and execute data-driven digital strategies that maximize their clients’ online investments. The team’s years of pharma experience have resulted in a unique understanding of proven strategies at all stages of a brand’s lifecycle and how to deliver innovative and effective programs within a complex regulatory environment. Klick Pharma offers custom end-to-end digital solutions to meet a variety of client needs, including strategy, experience design, technology, media, and learning solutions.

DISCLAIMERThe point of view is provided by Klick Pharma as an informational reference and subject to change without notice. Any opinions published here are those of the author(s) and are not meant to be exhaustive guidelines for online marketing compliance. The recommendations cited here have been developed based on Klick Pharma’s interpretation of what is currently happening in the marketplace and where the category appears to be going. Every effort has been made to present accurate and reliable information, but Klick Pharma assumes no responsibility or liability for any errors or inaccuracies that may appear in this document. Furthermore, this guide was not reviewed or developed in consultation with the FDA, and therefore all suggested approaches should always be vetted by your internal regulatory / compliance teams and receive appropriate FDA approvals. All brand names used are the trademarks of their respective owners. All of this information is provided “as is” and Klick Pharma disclaims any express or implied warranty, relating to the use of this information including warranties relating to fitness for a particular purpose, compliance with a specification or standard, merchantability or noninfringement.