FDA Guidance on Social Media & User-Generated Content

Comments Enabled

An Analysis of FDA Draft Guidance For Industry: Fulfilling Regulatory

Requirements for Postmarketing Submissions of Interactive Promotional

Media for Prescription Human and Animal Drugs and Biologics

January 2014

Access the FDA DrAFt GuiDAnce here

FDA released long-awaited draft guidance

governing the use of social media by

pharmaceutical and biotech marketers on

January 13, 2014.

While far from exhaustive, the document

contains, among other things, specific new

guidance on the use, documentation, and submission of social media and similar channels

that entail the use of user-generated content.

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Key issues are outlined here.

Do I Own It?If a company marketing a pharmaceutical or biotech brand exerts

significant influence over a site or online service, that firm has a

responsibility to submit the entire current contents of the site or service.

The definition of influence is the key. Merely buying advertising space on the site does not trigger ‘ownership’

responsibilities; the firm is still responsible for proper submission

of the advertising materials given to the site, of course. Dictating

or negotiating preferable placement of such advertising constitutes

influence of the sort that triggers ownership responsibilities.

We interpret this guidance such that, for instance, simple selection

of an expensive, prominent placement is permissible without

submission of the entirety of the surrounding content; purchase

of such a placement contingent on its appearance next to an

editorial column by a prominent KOL would trigger the requirement.

While this does not constitute a bright-line rule, we believe that this

guidance will suffice in most conceivable contemporary instances.

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The guidance reaffirms the obvious –

the marketer is responsible for regulatory submission of promotional communications

via services like Twitter, Facebook, etc.

The guidance also makes clear that the

firm is responsible for submitting such

communications as tweets from sales reps

or other employees, blogs or microblogs

maintained by employees or contractors,

etc. Thus, the company’s social media policy

should prohibit dissemination of promotional

content–even an innocuous tweet about

MOA–from employees unless specifically

requested.

Promotion on 3rd Party Sites

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The guidance makes it clear that

user-generated content (UGC) from non-affiliated users is NOT the responsibility of the firm, and need not be submitted. This applies to

third-party sites and, potentially, brand sites, if

they have a forum or similar venue for display or

dissemination of user-generated content. While

not addressed in this guidance, it should not be

construed that such guidance frees the firm from

established responsibility in regard to reporting of

adverse events, if identifiable adverse events are

asserted or suggested via UGC.

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UGC - Not your responsibility

Promotional communication IS your responsibility

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The final section of the guidance document, Recommendations

for Submitting Interactive Promotional Media, is a real eye-opener.

One can easily imagine the onerous regulatory submission burden

an active brand Twitter or Facebook account could generate.

FDA lays out a series of simple recommendations for pharmaceutical marketers.

nuts & boltsSuggested Submission Procedure & Timing

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“At time of first display, the firm should …submit in its entirety all sites for which it

is responsible on Form FDA 2253 or Form FDA 2301.” For example, if a brand site is

adding a comments feature, resubmit the entire site, and include the new feature,

with annotations to indicate its function(s).

Thereafter, the firm need only supply an updated listing of the site via form 2253 or 2301, every 30 days. The details of the listing are

provided on the following page.

Company-Controlled Sitesnuts & bolts

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For a third-party site (e.g., Twitter), the firm should initally

submit, as above, the ‘home page’ of the site and the

interactive page(s) within said site. Implementation of

this portion of the guidance will depend largely on the

third-party site in question. Here, once again, the burden for

ongoing regulatory submissions comprises submission of an updated listing, every 30 days, via form 2253 or 2301.

Third-Party Sitesnuts & bolts

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Less than we had suspected, frankly. Submitted under 2253 or 2301,

the listing comprises …”the non-restricted sites for which the firm is

responsible or in which it remains an active participant and that

include interactive or real-time communications.”

There is no requirement for a visual representation of the interactive communications. The listing includes only the site name, URL, and date range, along with

a cross-reference to the most recent submission of the site. Better yet,

multiple sites may be submitted under a single form. Our interpretation

is that all appropriate properties or sites for a given brand can be submitted

under a single 2253. Furthermore, we do not believe this necessitates

monthly updates to inventory/control numbers.

What’s in a Listing?

2253

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here is that FDA expects to see genuine, unaffiliated

UGC interspersed with promotional messages. It is

not necessary to ‘clean up’ the site at submission as

reviewers expect to see, for example, user-generated

tweets interspersed with branded tweets on a brand’s

Twitter page. Of course, any inappropriate UGC

should be removed per site moderation policy, but

that is not a matter FDA intends to exert particular

influence over.

is the case of restricted sites, like sites that require

a password (to post comments, anyway). In this

case, FDA wants to see the whole site, but again,

recognizing the realities of ‘real-time’ content,

FDA requests only that such submissions be made every 30 days.

Another notable point A notable exception

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The language and content of these recommendations make it apparent to us that

FDA is actively seeking to empower use of social media and other ‘real-time’ interactive promotional media. While the guidance is not

binding, FDA has stated that it will exert enforcement discretion around the key

items described in this document.

We feel that the risk exposure associated with pharmaceutical and biotech

brands’ use of social media networks, blogs, forums, etc. is substantially

less than in the past. The guidance presented is actionable and, on its

face, reasonable. As ever, FDA has avoided being overly specific in some

definitions, as a hedge against future actions that violate the intent

of this guidance.

Star Group’s View

And intent is the key here.

Star believes the quality of flexibility to be vitally important to success.

The tools of the trade will evolve over time, and it is important

that marketers evolve as well, while preserving core principles like

transparency, respect for the audience, and timeliness of response. This kind of ongoing and transparent conversation with patients, physicians,

caregivers, etc. is new for pharmaceutical marketers. A willingness to learn from

mistakes – and to make these mistakes in the first place – is paramount to success

in this realm.

Star Group feels strongly that a good faith

effort to engage in social media and other

interactive promotional media can pay substantial

dividends when deployed as part of an integrated

communications strategy to reach members of

key target audiences.

This good faith effort includes:

• Content strategy for key audiences• Clear value proposition for people

to engage with brand and its reps• Well-defined success metrics• Moderation policies and staff• Transparency• Flexible approach from all stakeholders

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Want 2 learn more?

Tim R. Garde Managing Partner

Star Group / Star Life Sciences Synegrated Communications

215.875.4313 (l) 215.815.0075 (m) tgarde@stargroup1.com

stargroup1.com starlifebrands.com

©2014 Star Group Communications, Inc.

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