What the one click rule means for the pharma industry

1. Page 1
POINT OF
VIEW
A bill currently in the House of Representatives
dubbed the “One Click Rule” would allow ISI
information to be included via a link, rather than
within the ad. This could have major
implications for the potential pharma brand use
of social media marketing, bringing us a step
closer to being able to have freer conversations
with those that need our products.
Each day, millions of people head to social
networks to share and gather information
related to their health. From large networks like
Twitter and Facebook, to niche disease state
specific networks, the opportunity to connect
and engage with your audience is unparalleled.
Over the past few years, we have seen pharma
becoming more comfortable with social media.
Many companies leverage social profiles across
the major networks for corporate initiatives,
while others have leveraged groups for HR and
internal communications.
More progressive organizations have also had
some success engaging communities with
unbranded or disease state specific content. As a
whole, the industry has been hesitant to adopt
comprehensive social strategies from a brand
perspective, often because of regulations.
However, with the introduction of a new house
bill, that may be about to change.
On May 20th, Missouri Republican Billy Long
introduced a bill to the US House of
Representatives to amend the Federal Food,
Drug, and Cosmetics Act. The bill (H.R. 2479)
would allow Pharma companies and marketers
“to disseminate in character-limited applications,
truthful, introductory information about medial
products, including the name of such products
and their approved uses.”
Most importantly, the proposed legislation would
treat hyperlinked information from a regulatory
perspective as if it were included within the
content. This would green-light what is known
across the industry as the “one-click rule.”
Potential of One Click Rule to Change
Pharma Marketing: How a Bill in Congress
Could Open Social Media for Pharma
June 2015
Executive Summary
“One click rule could have
major implications
…bringing us a step closer
to being able to have freer
conversation with those
that need our products.”
Background

2. Page 2
Whenever a brand and the disease state it’s
indicated for appear within the same content, the
ISI must be present. This has made it extremely
difficult to leverage character-limited social
networks like Twitter. Based on current FDA
regulations, brands are very restricted in what they
can and cannot do for DTC and HCP focused social
efforts. As you can imagine, the average ISI is much
longer than Twitter’s 140 character limit.
This “one-click rule,” pending approval from US
legislatures and revisions from the FDA, would
permit advertisers to include the full prescribing
information and safety concerns of a medical
product (drug, biological product, or device)
through a direct link, rather than in its entirety
within the ad content itself.
As long as the presentation and fair assessment of
risks and benefits of a product is a single click away,
the proposed bill would have the FDA view the
content as permitted and fairly balanced.
“…the proposed bill would
have the FDA view the
content as permitted and
fairly balanced.”
Although not pertaining to pharma, this update
rocked the boat in the industry all the same
with conjecture on how a similar FDA bill would
open up social media advertising to branded
efforts. Two years later, and this landmark
legislation is finally up for discussion.
Long’s bill would allow the FDA six months to
revise the draft of the proposed bill, and 18
months to adopt these final regulations. While
not requiring immediate action, this activity has
rightfully put the Pharma industry on notice.
The adoption of “one-click” legislation would
open up an incredibly large and engaged
market to promote specific drugs toward. Pew
Research indicates that 74% of online adults
use social networking sites. Twitter alone - the
originator of character-capped media - has over
302 million active monthly users.
One-Click Rule
Legal Precedent
Long desired by pharma marketers, this legislation
is not without precedent. While not in oversight of
pharma advertising, ceding that responsibility to
the FDA, the Federal Trade Commission (FTC)
passed a similar bill in 2013.
On March 12, 2013 the FTC published a revision to
their Dot Com Disclosures stating that “when it is
not possible to make a disclosure in a space-
constrained ad, it may, under some circumstances,
be acceptable to make the disclosure clearly and
conspicuously on the page to which the ad links.”
Implications
The adoption of “one-click” legislation would
open up an incredibly large and engaged market
to promote specific drugs toward. Pew Research
indicates that 74% of online adults use social
networking sites. Twitter alone - the originator of
character-capped media - has over 302 million
active monthly users.

3. Page 3
Justin Freid
Vice President, Search Engine
Marketing & Emerging Media
Communications Media, Inc.
Analysts:
If the FDA regulations were revised, the largest
change would be in relation to the content
brands are able to share and promote about their
brand and the indication. Currently, most short
form social updates stay away from mentioning
the disease state. This change would allow more
flexibility for brands to control what content they
decide to share or include in their profiles on
social networks.
With clearer, more defined guidelines, legal and
regulatory teams also would have a better
understanding of what brands can leverage from
a social perspective. This could help with any
current hesitation caused from the lack of clarity
the FDA has provided with past social media
guidance.
With this bill and the additional guidance
provided, brands will have more freedom to
help people achieve better health outcomes by
building stronger, more interactive relationships
with the people who use their brands. Social
media has grown so significantly, the average
consumer expects brands to engage and
respond with valuable information. If this bill
passes, the pharma industry will be one big step
closer to living up to those expectations.
How Will This Bill Affect Pharma
Brands?
Cory LeBihan
Associate Search Analyst
Communications Media, Inc.
“The adoption of one-
click legislation would
open up an incredibly
large and engaged
market to promote
specific drugs toward.”
.”