Using YouTube to Promote Pharmaceuticals:

A Guide to YouTube for Regulatory Professionals

June 21, 2010 Analyst: Dale Cooke, VP/DIR | Regulatory Review

YouTube dominates online video.1 If your goal is to reach people viewing video online, YouTube has to be
considered. Yet, based on actual usage2, pharmaceutical companies appear reluctant to use it. The aversion cannot
be explained as an aversion to video itself or even online video because both have proliferated. Television advertising
continues to be an enormous portion of overall ad spend 3, and product and disease education websites frequently
feature online video.

Beyond the mere popularity of YouTube, there are significant additional benefits to it. First, people uploading videos
get a free player for their videos instead of having to build one. Second, YouTube has very good accessibility options,
including closed captioning in video streams, making videos widely available to people who might otherwise have
difficulty viewing them. Third, YouTube is extremely friendly to search engines, especially Google, which means it is
much easier for people to find videos if they’re hosted on YouTube. Fourth, YouTube can be accessed from all
current mobile devices4, and recent developments5 suggest mobile video viewing will be growing tremendously.

Given these benefits, there must be something about YouTube itself that is causing concern and accounts for the low
usage by pharmaceutical companies.6 In this guide, we examine what companies must take into account when
considering YouTube. We then look at what additional considerations apply to implementing unbranded, help-seeking
materials on YouTube versus product-specific promotions. This guide is intended to assist in determining whether and
how to make use of YouTube.

Username and Channel Name7

To upload videos to YouTube, users must open a YouTube account. The only requirements are having an email
address and selecting a username. Current usernames for pharmaceutical companies on YouTube fall into one of
three categories:
1. Using some form of the company name, (e.g., PfizerClinicalTeam, GenentechVideo, and Novartis)
2. A disease state, condition, or treatment, e.g., goinsulin (for sanofi-aventis) or ADHD (for Johnson &
Johnson’s Concerta channel) or
3. Combining both, e.g., TibotecHCV (for Tibotec’s Hepatitis C channel).

USERNAME CONSIDERATIONS
1. Use of Brand Name
FDA has made clear in several enforcement actions related to search engine marketing8 that use of the
brand name in website URLs includes all of the same requirements as other mentions of the drug, including
the requirement to provide the generic name with the brand name. Applying that reasoning to YouTube
usernames means either excluding the brand name from the username or including both the brand name
and the generic, though note that YouTube usernames can only include letters and numbers, with no special
characters such as parentheses available to set off the generic from the brand name. Consequently, it is
advisable to avoid all brand names in usernames.

2. Avoidance of Claims
Usernames making an implicit or explicit claim (CureForX) would require corresponding risk information to
maintain fair balance for the overall presentation. Creating that balance requirement in the username itself
could create limitations on later potential uses to drive users to the account, so it is advisable to avoid any
claims in the username.

MODIFYING A VIDEO FOR USE ON YOUTUBE9

One issue related to the online video needs to be taken into account for any online presentation, regardless of
whether it is on YouTube or on a separate website.

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This is the issue of size. Videos on YouTube might be viewed either in the full-screen display mode or the much
smaller normal player size. FDA has frequently emphasized the crucial role played by the presentation of risk and
benefit information and that the manner of display can cause material to be in violation even if the content of the
message itself is not problematic.

For example, a recent enforcement letter10 sent to Novartis for an email promoting Voltaren Gel (diclofenac sodium
topical gel) noted that the email minimized the risk information because “the risk information is relegated to the
bottom of the email and is presented below the indication for use in extremely small black font, and in single-
spaced paragraph format that makes the information very difficult to read.” (emphasis added)

Visuals including on-screen supers, warnings, and other information that are quite sufficient for the full-screen display
might be too small when seen in the normal player size. So, the video must be reviewed in the smaller display to
ensure that presentation also meets the fair balance requirement.

UPLOADING A VIDEO TO YOUTUBE

In the process of uploading a video to YouTube, a user must make certain decisions that have regulatory
implications.11 In this section, we review those decisions and explain each.

Title
This is the name of the video that will appear above the player on YouTube and will show up in search results.

Description
This is the description that will appear beneath the video when it is viewed. Some pharmaceutical companies place
their major statement or other risk information in the description field. The description does not appear in its entirety in
all views of a video, so users must consider both the complete description and the shortened version of the
description.

Tags
Tags facilitate searching for videos. Tags also appear below a video while it is playing.

Categories
Categories assist YouTube in classifying video and assist searches. The currently available categories are:
1. Autos & Vehicles 9. News & Politics
2. Comedy 10. Nonprofits & Activism
3. Education 11. People & Blogs
4. Entertainment 12. Pets & Animals
5. Film & Animation 13. Science & Technology
6. Gaming 14. Sports
7. Howto & Style 15. Travel & Events
8. Music

Privacy
There are three privacy options.
1. Public (anyone can search for and view)
2. Unlisted (anyone with the link can view)
3. Private (only specific YouTube users can view)

Unlisted videos are private videos that users want to allow others to share but don’t want to fully open to the entire
world. Someone with access to a video can send the link via email to another user who has not been explicitly given
permission to view a video. By contrast, private videos require the user uploading the video to specify every individual
YouTube account holder who can view a video.

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Comments
There are four options for commenting on a video:
1. Allow comments automatically
Any person who sees the video may comment on it and the comments will appear beneath the video without
moderation. Comments can be deleted after they appear.
2. Allow friends' comments automatically, all others with approval only
People who have become friends of a user may comment without having their comments moderated. All
other users can propose comments, but the comments must be approved before they appear. Again, all
comments can be deleted after they appear.
3. Allow all comments with approval only
This allows any individual to comment on a video, but the user uploading the video must approve each
proposed comment before it appears.
4. Don't allow comments
This prevents all comments from appearing. The following message appears beneath the video: “Adding
comments has been disabled for this video.”

Comment Voting
This enables users to vote on whether an individual comment is useful, by voting up or down on individual comments.
If commenting is disabled, comment voting is also disabled.

Video Responses
In addition to a text comment, YouTube frequently features video responses. Users have three options for video
responses:
1. Yes, allow video responses to be added automatically.
2. Yes, allow responses after we approve them.
For this option, users may submit video responses, but they will only appear after the user uploading the
initial video approves them.
3. No, don't allow video responses.

Ratings
If permitted, ratings allow users to indicate a like (by clicking on thumbs up) or dislike (by clicking on thumbs down). A
tally is displayed showing total results of the ratings (e.g., nine up and four down).

Embedding Videos
Embedding a video allows, for example, users to view a clip of last night’s Jay Leno monologue on The New York
Times website. People copy code (or click on a link) to embed the video from one site into another. YouTube permits
users to enable or disable embedding a video. Permitting embedding gains viewers outside of YouTube. Indeed,
many sites encourage others to embed their videos to increase audience.

There is, however, a potential downside. YouTube permits users to either permit embedding or prevent it; but there is
no in-between. It is not possible, for example, to require people to request permission before embedding a video on
another site. Consequently, if this option is turned on, there is no way to control the surrounding context of your video
after it is embedded on another site.

No pharmaceutical company has ever received an enforcement action from the FDA related to embedding.
Nonetheless, permitting videos to be embedded does entail releasing control of the surrounding context of
promotional material in a way that most pharmaceutical companies are not used to.

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Syndication
Enabling this option permits videos to be translated into another format that can be viewed on mobile devices (which
is one of the advantages of YouTube mentioned above) and the nascent YouTube TV.

Date and Map

YouTube enables users to identify where and when a video is taken and to share that information with others.

THE CHANNEL PAGE

Uploading a video automatically creates a channel on YouTube. The channel page gathers all of the videos uploaded
by a user. The channel page has various modules that users can choose to have appear and some customization of
these modules is available. Any of these modules can be prevented from appearing on the channel page by
unselecting them from the “Modules” tab at the top of the channel page. The currently available modules are:

Comments
Comments provide users the ability to post responses and reactions to the channel. If the commenting module is
enabled, there are four options for how they are allowed.
1. Everyone can automatically comment.
2. Friends can automatically comment, all others only with approval.
Users who have been accepted as a friend by the channel owner will have the ability to comment on the
channel, but everyone else will have to request permission to comment on the channel. (See below for
more information about friends.)
3. Only friends can comment.
4. Everyone can only comment with approval.
Note that this option means that individuals must request permission to comment, but once given
permission, individual comments are not moderated.

Moderator
This option allows channels to solicit feedback from people viewing the channel by specifying a time for receiving
questions, ideas, or suggestions.

Subscribers
Subscribers are people who have requested alerts about a channel. The subscriber module shows the username and
any profile icon for users who have subscribed to the channel. Not showing this module on a channel does not
disable the ability of users to subscribe to a channel. It simply means that users cannot see who is subscribing to the
channel.

If displayed, all people subscribing to a channel are displayed. It is, of course, possible that an individual
username/icon is disparaging or otherwise inappropriate; and such users can be denied the ability to subscribe to a
channel and thus their username and icon will not appear in the subscribers module. It is NOT possible to enable
such users to be subscribers but not appear in the module.

Friends
Friends are YouTube users who have sent a request to “Add as Friend” the channel and have been approved by the
channel’s owner. Being a friend on YouTube provides certain enhanced accessibility, such as viewing videos
restricted to friends, or commenting on videos when commenting is restricted to friends. Comparable to the
subscribers modules, the friends module displays the username and any profile icon for users who have been
accepted as a friend.

Other Channels
This module permits a channel owner to suggest other channels. For example, a corporate channel might use this
module to list all of the individual product or disease condition channels sponsored by the corporation. Of course, if

June 21, 2010 Digitas Health YouTube POV Page 4 of 6

this is used, consideration must be given to the meaning of multiple listings and whether those listings imply any
cross-promotions.

Subscriptions
This module shows the other channels that a channel owner subscribes to.

Groups
Groups allow users with a common interest to share videos on YouTube with each other. The groups module allows
people to see all of the groups to which the channel’s owner belongs.

Recent Activity
This module displays all of the recent actions taken by the channel’s owner across YouTube. For example, if the
channel’s owner has recently commented on a video, uploaded a new video, or taken another action on YouTube,
that information would be displayed in this module.

HELP-SEEKING MATERIALS
In addition to the concerns discussed above, there are the standard concerns to ensure that help-seeking materials
do not become product-specific promotions. FDA has consistently maintained that the simple omission of a product
name does not guarantee that a particular communication is considered a help-seeking promotion that is exempt
from the requirements of the Food, Drug, and Cosmetic Act (the act) and implementing regulations regarding product-
specific promotions, and nothing exempts YouTube videos from this requirement.

As discussed in the FDA Draft Guidance for Industry ‘Help-Seeking’ and Other Disease Awareness Communications
by or on Behalf of Drug and Device Firms, perceptual similarities and the close physical and temporal proximity of
material that is allegedly help-seeking to material that is clearly promotional can cause the allegedly help-seeking
material to be deemed product-specific promotional material that is subject to the requirements of the act.

Quoting from the Guidance12:

“FDA recommends that manufacturers, packers, and distributors ensure that their disease awareness
communications and reminder promotional pieces or product claim promotional pieces are sufficiently
distinctive in terms of their thematic, graphic, visual and other presentation elements so that they will not be
perceived as a single promotional piece that includes both a product name and a use, and is thus subject to
the requirements for ‘labeling’ or ‘advertising’ mandated by the act and regulations.” (page 7)

This advice carries over verbatim to YouTube. Both in the videos presented on YouTube and the associated
information such as the channel design, username, etc., there should be no implicit connection to any specific
products provided by the company responsible for the help-seeking materials.

Some companies have gone so far as to include risk information applicable to a class of products in materials that are
intended as help-seeking. For example, Johnson & Johnson’s goinsulin channel, which does not mention any specific
product on the page or in the videos, includes the following statement:

Important Safety Information for Insulin

Possible side effects may include blood sugar levels that are too low, injection site reactions, and allergic
reactions, including itching and rash. Tell your doctor about all other medicines and supplements you are
taking because they could change the way insulin works. Glucose monitoring is recommended for all patients
with diabetes.

June 21, 2010 Digitas Health YouTube POV Page 5 of 6

KEY RECOMMENDATIONS
1. Keep usernames free of claims and avoid the brand name in usernames.
2. Ensure videos are formatted to provide a balanced presentation in the smaller video player available online.
3. Understand all of the decisions made while uploading a video.
4. Understand the distinct decisions needed concerning a channel. Many of these decisions share terminology
with those about an individual video, but they are not identical.
5. Ensure help-seeking materials are distinct from product-specific promotional materials.

NOTES
1. According to a June 1, 2010, press release from comscore, Google properties (overwhelmingly represented by YouTube) accounted for
more than 43% of all online video views. The second highest percentage was 3.2% by Hulu. Google sites (again primarily YouTube) also
had the most people viewing videos with nearly three times as many unique viewers as Yahoo!, which ranked second. Last accessed
June 17, 2010, from
http://www.comscore.com/Press_Events/Press_Releases/2010/6/comScore_Releases_April_2010_U.S._Online_Video_Rankings
2. One prominent blogger (http://www.eyeonfda.com/eye_on_fda/2010/06/checking-in-on-pharma-and-
youtube.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed:+eyeonfda/lpWT+(Eye+on+FDA)&utm_content=Google
+Feedfetcher) identifies 16 YouTube channels developed by pharmaceutical companies, while another online wiki of social media efforts
by pharmaceutical companies identifies 31 total uses (http://www.doseofdigital.com/healthcare-pharma-social-media-wiki/).
3. DTC Perspectives reported in its June 2010 issue on numbers provided for many (though not all) types of advertising. According to that
report, television represented 66% of the total advertising spend. DTC Perspectives, June 2010, page 12.
4. Famously, the Apple iPhone and iPad do not permit use of the Flash plug-in, which is one of the most popular formats for online video;
and only recently has any mobile device been enabled with a version of Flash. That version still does not fully enable viewing videos on
websites using mobile devices. See Steve Jobs, “Thoughts on Flash”, April 2010 http://www.apple.com/hotnews/thoughts-on-flash/ and
David Pogue “A Bold Phone Fades a Bit in the Details,” June 2010
http://www.nytimes.com/2010/06/17/technology/personaltech/17pogue.html?ref=personaltech
5. Among the recent developments that bode well for massive increases in mobile video are the upgrade of the U.S. wireless network to 4G
capacity (which can speed data up to four times faster than the current 3G network), the release of new devices such as the Apple iPad
and other tablet computers, and growth in both smartphone usage and in the platforms available, via Google’s Android operating system
for phones, the prevalence of Linux netbooks, and the eagerly anticipated Google Chrome operating system.
6. The FDA has taken only one enforcement action for a video posted on YouTube. That letter (MACMIS# 15563) was sent to Shire for a
video featuring a testimonial by Ty Pennington for Adderall XR (mixed salts of a single-entity amphetamine). Interestingly, none of the
issues raised by the FDA related to the use of YouTube per se. Instead, the violations were overstatement of efficacy, omission of risk
information, and failure to submit under cover of form 2253. Last accessed June 18, 2010, from
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLe
tterstoPharmaceuticalCompanies/ucm049750.htm
7. Note that even if the intention is simply to upload a single video, YouTube automatically creates a generic channel for all users; so there is
no option to create a user account independently of creating a channel.
8. See, for example, the March 26, 2009, letters sent to Merck & Co. for Januvia (sitagliptin) MACMIS# 17312; Bayer for Levitra (vardenafil
HCl) MACMIS# 17307; Boehringer Ingelheim for Flomax (tamsulosin hydrochloride) MACMIS# 17308; Biogen Idec for TYSABRI
(natalizumab) MACMIS# 17314; Genentech for Xolair (Omalizumab) MACMIS# 17309; GlaxoSmithKline for Avodart (dutasteride)
MACMIS# 17317; Johnson & Johnson for Prezista (darunavir ) MACMIS# 17310; Novartis for Femara (letrozole tablets) MACMIS# 17313.
Last accessed June 18, 2010, from
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLe
tterstoPharmaceuticalCompanies/ucm055773.htm
9. Note that this section focuses on the format unique to online presentations of video. There’s no reason to believe that the videos
themselves bear any special requirements while appearing on YouTube, and nothing in any recent enforcement action or guidance from
the FDA has changed that. Indeed, there’s every reason to believe that online video presentations are more easily able to deal with
regulatory requirements associated with broadcast video, such as the adequate provision requirement, as online presentations naturally
facilitate providing a link to the prescribing information as opposed to merely mentioning in a television ad the website where users can
later go to get the prescribing information.
10. Letter sent April 14, 2010, to Novartis for Voltaren Gel (diclofenac sodium topical gel) MACMIS # 18396. Last accessed June 18, 2010,
from
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLe
tterstoPharmaceuticalCompanies/ucm197224.htm
11. Although each of the decisions discussed in this section must be made when initially uploading a video, all of them can be changed after
uploading.
12. Last accessed June 21, 2010, from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064956.htm

June 21, 2010 Digitas Health YouTube POV Page 6 of 6