The FDA has issued new guidance on the reporting requirements for drug and biologic companies engaging in web-based product promotion. The guidance outlines three scenarios where promotional materials must be submitted to the FDA: 1) materials on company-owned sites, 2) materials on third-party sites where the company has influence or control, and 3) materials generated by company employees or agents. It also provides recommendations for submitting interactive or real-time website content, including initial site submissions and monthly updates. While some uncertainty remains around levels of influence and employee actions, the guidance aims to clarify FDA expectations around online promotional reporting.

1. FDA Issues Guidance on Reporting
Requirements for Web-based
Promotion of Drugs and Biologics
REGULATORY & MARKETPLACE
8 INTERNATIONAL PHARMACEUTICAL INDUSTRY Summer 2014 Volume 6 Issue 2
The FDA has finally given some
guidance on what drug companies must
do to comply with federal reporting
requirements when marketing their
products through social media websites
and other interactive media. This alert
summarises this new and long-awaited
guidance from the FDA.
Background on ‘Post-marketing
Submissions’ to the FDA
Drug companies must submit to the
FDA copies of all documents used to
promote pharmaceuticals and biologics
in the United States. This includes print,
television advertisements, and online
advertisements. The FDA reviews these
“post-marketing submissions” (so called
because they typically are submitted to
the FDA immediately after they have been
published) to ensure that they comply
with regulations requiring elements such
as disclosure of known risks and citations
to evidence supporting all claims made in
the promotional materials.
With the emergence of social media
sites – where a drug company may have
limited control over how its products
are discussed and how its marketing
materials are disseminated – the
reporting obligations have been unclear.
Must a company provide the FDA with
a copy of every tweet or Facebook post
about its product?
In July 2012, after many years of silence
from the FDA on the issue, Congress gave
the agency a two-year deadline to issue
some guidance. On January 13, 2014,
the FDA released “Guidance for Industry:
Fulfilling Regulatory Requirements for
Post-marketing Submissions of Interactive
Promotional Media for Prescription
Human and Animal Drugs and
Biologics.” The document notes that it is
a draft only but notes that the document
“when finalized, will represent the [FDA’s]
current thinking on this topic.”
New Guidance from the FDA
The document lists three broad scenarios
in which a company (or “firm”) should
submit its online promotional materials
to the FDA. The following is a summary
only. The complete guidance is available
here.
Scenario1:Promotionalcommunications
on sites that are owned, controlled,
created, influenced, or operated by, or
on behalf of, the firm.
This category of site includes micro-blog
sites such as Twitter, social networking sites
such as Facebook, and “other sites that
are under the control or influence of the
firm.” To determine whether a company
has control or influence, the FDA looks
to whether the company – or anyone
acting on its behalf – is “influencing or
controlling the promotional activity of
communication in whole or in part.”
If a drug company “has editorial, preview,
or review privilege” over the content of
the promotional materials provided to a
website, then the company is responsible
for that content and should submit such
materials to the FDA. This would seem
to include any promotional materials the
company disseminates through its official
Facebook, LinkedIn, or Twitter account.
Scenario 2: Promotional materials on
third-party sites.
A company is responsible for promotion
on third-party sites if the company has
“any control or influence on the third-
party site, even if that influence is limited
in scope.” As with the sites described in
scenario 1 above, if the drug company
collaborates or has editorial, preview, or
review privileges, then it is responsible
for its promotion on the site and should
submit the promotional documents to the
FDA.

2. If a company provides only financial
support (for example, through an
unrestricted grant) but has no other
control or influence on the site, then the
firm is not responsible for information
on the third-party site. Also, if a firm is
merely providing promotional materials
to a third-party site but does not direct
the placement of those materials within
the site – and has no other control or
influence on that site – the firm is only
responsible for the content it places there
and only must submit to the FDA the
material that was submitted to the site.
Scenario 3: A firm is responsible for the
content generated by an employee or
agent who is acting on behalf of the firm
to promote the firm’s product.
A drug company’s reporting obligations
to the FDA extend to promotional activities
that are conducted on the company’s
behalf. For example, if an employee or
agent, acting on the company’s behalf,
comments on a third-party site about
the firm’s product, the firm is responsible
for the content its employee or agent
provides. This obligation extends to
content on a blogger’s site if the blogger
is acting on behalf of the company, and
to user-generated content (UGC) such as
comments in discussion forums if those
comments are made on behalf of the
company.
The FDA’s guidance offers two examples
of this scenario. First, if a sales rep
acting on behalf of the company posts
comments about the innovative release
mechanism of the company’s product
on an independent third-party site, the
company is responsible for submitting
the comments to the FDA. Second, if a
blogger paid by the company maintains
a blog about the company’s product, the
company likewise is responsible.
New Recommendations for Submitting
Interactive Promotional Media
The new guidelines acknowledge that
some websites include promotional
content that changes in real time, and
it is impractical for companies to submit
copies of each instance of the constantly
evolving webpage. For these situations,
the FDA offers the following guidance.
Submission of Websites that Have
Interactive Parts that Update in Real Time
At the time that a promotional website is
initially displayed, the company should
submit the entire website using Form FDA
2253 or Form FDA 2301 (the “Forms”).
The company should include annotations
to describe the parts that are interactive
and allow for real-time communication.
Any subsequent changes to the site (other
than changes in the real-time information)
should be annotated and resubmitted to
the FDA.
Submission of Third-Party Sites in which
a Company’s Participation is Limited to
Interactive or Real-Time Content
The company should submit the home
page of the third-party site, along with the
interactive page within the third-party site
and the company’s first communications
therein, using the Forms. The company
may include annotations that describe
its communications within the third-party
site.
Monthly Disclosure of Websites
Once every month, a company
should submit to the FDA an updated
listing of all non-restricted (i.e., non-
password protected) sites for which it
is responsible, or in which it remains
an active participant, and that include
interactive real-time communications.
For these monthly submissions, the party
need not include in the Forms screenshots
of the actual interactive or real-time
communications. Companies should
include a separate document for each
site that includes the site name, URL, and
date range, as well as a cross-reference
to the date of the most recent submission
of the site. The company should advise
the FDA on the first day that the company
stops being active on the site.
Additional Requirements for ‘Restricted’
Websites
If a site has restricted access such that
the FDA may not have access to the site,
the company should submit all content
related to the discussion (including all
UGC about the topic) to provide context
for the review. Screenshots or other visual
representations of the actual site should
be submitted monthly using the Forms.
Conclusion
The new guidelines leave some
uncertainty. For example, the degree
of influence or control that a company
exerts over a website that will trigger a
company’s reporting obligations will be
a case-by-case determination that the
company itself must make. Another gray
area is when an employee acts “on behalf
of” the company such that the employee’s
online comments must be submitted to the
FDA. Despite this lingering uncertainty,
the new guidance is a welcome glimpse
into the FDA’s current thinking on what a
company must do to comply with federal
post-marketing submission requirements.
Nick Nelson is an
associate in the
Business Litigation
Practice Group in
the Dallas office of
Haynes and Boone,
LLP. His practice
focuses on trade
secret, trademark,
and copyright litigation and all facets of
media law.
Email: nick.nelson@haynesboone.com.
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