FDA, Social Media, & Online Pharma
Adver7sing
Answers to Ques7ons
from Investors
John Mack
Publisher, Pharma marketing News &
Pharma Marketing Blog
@pharmaguy on Twitter
johnmack@virsci.com

Introduc7on
Investors who own stocks or who are thinking of buying stocks of major online
Health sites are worried. They have lots of ques7ons about FDA's plans for
regula7ng drug promo7on on the Internet.
As we know, when FDA regulates, markets react. When FDA sent out those 14
NOV leOers, for example, branded paid search engine marke7ng by pharma
experienced a "Prompt, Precipitous, & Prolonged" Plummet (see here). That
could have been just a coincidence; I have heard that Google is worried about
an overall decline in paid search engine adver7sing.
Anyway, an Internet research team at a major regional brokerage and
investment banking firm that provides investment advisory services to
individual investors and professional money managers invited me to speak to
some of their clients via conference call about the recent FDA public hearing on
the Internet and its repercussions.
The following are the first round of ques7ons they have asked prior to the call
and my answers.

3
Areas of Interest/Ques7ons
FDA Hearings Background
− Why did the FDA hold public hearings?
− What is the FDA trying to accomplish?
− What is the 7meline for FDA ac7on?
− Is the FDA trea7ng the Internet as just another media like print or
TV or are they trea7ng the Internet as a new medium?
Key Takeaways following the FDA public hearings
– What are key takeaways from the hearings?
– Do the pharma companies want regula7on regarding online
adver7sing and if so why?
– Are pharma companies wai7ng for regula7on before introducing
online marke7ng campaigns?

4
Areas of Interest/Ques7ons (cont’d)
Future Regula7on
− How will the FDA define what pla^orms and par7cipants will be
governed by FDA regula7on?
− Following the hearings, are pharma companies are more inclined
to adver7se online now or wait for FDA guidelines?
Emerging Online Adver7sing Formats
– Are any of the new forms of search ads effec7ve and likely to
receive FDA approval?
– Do you expect pharma adver7sers to return to paid search?
– What online adver7sing trends you’ve seen from pharma
companies in recent months?
– What new trends to you expect in online adver7sing and social
media in the future?

Background
Why did FDA hold public hearings? In April, 2009, FDA sent out 14 NOV le:ers
regarding search engine adverAsing. These le:ers shot down the so‐called “one‐
click rule,” which pharma marketers were applying to paid search ads. That rule
stated it was OK to menAon a brand name drug and its indicaAon without
menAoning any side effects as long as the full prescribing informaAon (PI) was
one click away. Because of that acAon FDA received a lot of complaints. Soon
aTer that, I called for a public hearing on my blog. The rest is history!
What are they trying to accomplish? FDA typically holds Part 15 hearings as part
of its process to determine whether or not new guidance should be issued
and/or what research may need to be done in order to fulfill their mission. That
being said, there is no guarantee that having a public meeAng will lead to new
guidance. My view is that FDA already had decided that new guidance is
required and that they need to start the comment process, which was very
hasAly put together. It was well‐organized with regard to logisAcs, but poorly
adverAsed and organized in terms of ensuring that all stakeholders had a voice.
Do you have different answers or comments to add? See hOp://bit.ly/8z8JZM

Background (cont’d)
Next Steps/Timeline? Unofficial comments from FDA personnel plus the hasty convening of
the public hearing suggest that DRAFT guidance will be released by the end of 2010. ATer
that there will be another comment period before FINAL guidance will be released. I expect
that the process will be faster than in the past, unless FDA decides to bite off more than it
can chew. In that case, it will take a long Ame to issue any guidance and it will be out of date
as soon as it is published. A much be:er approach, IMHO, would be to tackle a few issues at
a Ame. FDA could, for example, issue guidance regarding space limitaAons imposed by
certain tools such as Twi:er (and other SMS, text‐based apps) and services such as search
engine ads. FDA could officially sancAon the "one‐click rule" in these cases as long as certain
criteria were met, such as proposed by Google and PhRMA.
THIS IS NOT YOUR FATHER’S FDA:
Expect faster response, more transparency.
FDA may accept help with research and from working groups to help decide what
issues to focus on first, etc.
Do you have different answers or comments to add? See hOp://bit.ly/8z8JZM

Background (Cont’d)
Will FDA remain “media agnos7c” or treat the Internet as a new medium?
Many presenters at the hearing made the point that the Internet and social
media are different and IMPORTANT to the public health. The Internet, for
example, is accessed first by consumers seeking health informaAon ‐‐ before
asking their doctors even. In his closing remarks, Tom Abrams, Director of FDA's
Division of Drug MarkeAng, AdverAsing, and CommunicaAons (DDMAC), said
"what we have heard is [the Internet is] a different medium.” As far as I know,
this is the first Ame that anyone at the FDA has said that. Usually, the FDA says
it's "media‐agnosAc." In other words, FDA regulaAons apply to all media and do
not have to be modified for any parAcular medium. That thinking, however, was
applied only to the Internet. There is precedent for issuing media‐specific
guidance: the 1997 “adequate provision” guideline for broadcast TV ads; ie, a
brief statement about major risks can take the place of enAre PI as long as
“adequate provision” was made to reference a toll-free phone number, a Web site, or
a current issue of a magazine that contains a print ad where the full safety
information could be found.
Do you have different answers or comments to add? See hOp://bit.ly/8z8JZM

Key Takeaways
The FDA is aware that the Internet and social media can have an impact ‐‐
posiAve or negaAve ‐‐ on public health and its regulaAons may play a major role
Apping the scales one way or the other.
The drug industry is more afraid of being leT out of the conversaAon than it is of
FDA issuing guidelines that restrict how it can engage in the conversaAon. Any
guidance is be:er than none at all.
The industry needs and wants the “one‐click rule,” especially for search engine
markeAng (SEM), which works best with branded ads.
Some good ideas were presented at the hearings such as Google’s new
standards for product claim paid search ads, which will likely be approved by the
FDA. Bayer/YAZ is already using the new Google format, which is in beta test.
Other pharma companies may follow that lead.
Do you have different answers or comments to add? See hOp://bit.ly/8z8JZM

Future Regula7on
Following the hearings, are pharma companies are more inclined to adver7se
online now or wait for FDA guidelines?
Most companies are likely to wait and see what, if any, guidelines the FDA issues before
iniAaAng any risky online campaigns; ie, branded search ads using Google’s standards,
branded Tweets, and openly engaging in conversaAons with consumers on social media
sites. It appears that pharma companies are increasing the amount they are spending on
online display adverAsing according to the latest TNS MI data; ie, this spending more than
tripled to $221 million in Q1 through Q3, 2009 vs the same period in 2008, according to DTC
PerspecAves. This type of adverAsing is not likely to be the subject of future FDA guidelines
and it is a simple ma:er to ensure they comply with exisAng regulaAons. There may be more
advanced and expensive types of ads that employ rollovers and other techniques that help
present more benefits as well as fair balance as required.
Do you have different answers or comments to add? See hOp://bit.ly/8z8JZM