2. History of Direct-to-Consumer (DTC) Advertising
in the Pharmaceutical Industry
 The FDA regulates advertising for prescription drugs.
 In most cases, federal law does not allow the FDA to require that drug
companies submit ads for approval before the ads are used. The FDA sees
many ads the same time the public sees them. Many drug companies
voluntarily seek advice from the FDA before they release TV ads. However, if
the FDA believes that an ad violates the law, they will send a letter to the
drug company asking that the ads be stopped right away.
 What must product claim ads tell you?
 At least one approved use for the drug
 The generic name of the drug
 All the risks of using the drug
 Under certain circumstances, ads can give only the most important risks.
Source: The U.S Food and Drug Administration

3. History of DTC Advertising in the Pharmaceutical
Industry – Traditional Media
 Prior to 1997, advertisements that mentioned a brand name
pharmaceuticalwere required to include that specific drug’s “brief summary” -
asummation of side effects, contradictions and effectiveness.Typically
anything but brief, the “Brief Summary” is the technical name for the detailed information
that appears in ads for prescription drugs.
 Brief Summary as set forth by the Food and Drug Administration (FDA) - The law
requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the
risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug.
 The brief summary generally includes:
 Who should not take the drug
 When the drug should not be taken
 Possible serious side effects of the drug and, if known, what can be done to lower
the chance of having them
 Frequently occurring, but not necessarily serious, side effects
 The "brief summary" includes a lot of information, so it is usually presented on its own
page of a print ad. When the "brief summary" is part of an ad directed at the consumer,
the FDA encourages drug companies to use language consumers can easily understand.
Source: The U.S Food and Drug Administration

4. A “Brief Summary” of PRISTIQ by
Pfizer
 PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for theTREATMENT OF:
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2
weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms:
 depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or
hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed
thinking or impaired concentration, or a suicide attempt or suicidal ideation.
 SIDE EFFECTS: PRISTIQ can cause serious side effects, including:
 Increased suicidal thoughtsor actions in some children, teenagers, and young adults within the first few months of
treatment.
 Depression and other serious mental illnessesare the most important causes of suicidal thoughts and actions. Some
people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family
history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
 Serotonin syndromeor neuroleptic malignant syndrome (NMS)-like reactions.
 Signs and symptoms of these syndromes may include one or more of the following:
 restlessness
 increase in blood pressure
 hallucinations (seeing and hearing things that are not real)
 diarrhea 36
 loss of coordination
 Coma
 fast heart beat
 Nausea
 increased body temperature
 Vomiting
 muscle stiffness
 confusion

5. A “Brief Summary” of PRISTIQ (continued)
 PRISTIQmay also cause other serious side effects, including:
 New or worsened high blood pressure (hypertension). Your healthcare provider should monitor your
blood pressure before and while you are taking PRISTIQ. If you have high blood pressure, it should be
controlled before you start taking PRISTIQ.
 Abnormal bleeding or bruising. PRISTIQ and other SNRIs/SSRIs may cause you to have an increased chance
of bleeding. Taking aspirin, NSAIDs (non-steroidal antiinflammatory drugs), or blood thinners may add to
this risk. Tell your healthcare provider right away about any unusual bleeding or bruising.
 Glaucoma (increased eye pressure)
 Increased cholesterol and triglyceride levels in your blood
 Symptoms when stopping PRISTIQ (discontinuation symptoms). Side effects may occur when
stopping PRISTIQ, especially when therapy is stopped suddenly. Your healthcare provider may want to
decrease your dose slowly to help avoid side effects. Some of these side effects may
include:
 dizziness
 anxiety
 nausea
 abnormal dreams
 headache
 Tiredness
 Irritability
 Sweating
 sleeping problems (insomnia)
 Diarrhea
 Seizures (convulsions)
 Low sodium levels in your blood. Symptoms of this may include:
 headache
 difficulty concentrating
 memory changes
 confusion,
 weakness and unsteadiness on your feet.

6. A “Brief Summary” of PRISTIQ (continued)
 Additional side-effects of PRISTIQ:
 Insevere or more sudden cases, symptoms can
include:
 hallucinations (seeing or hearing things that are not
real)
 fainting
 Seizures
 Coma
 If not treated, severe low sodium levels could
be fatal.
 Allergic reactions. Some reactions can be severe such as
swelling beneath the skin (e.g., throat, face, hands).

7. A “Brief Summary” of PRISTIQ (continued)
 Common side effects with PRISTIQ include:
 nausea
 tiredness
 Headache
 Diarrhea
 dry mouth
 Vomiting
 sweating
 anxiety
 dizziness
 Tremor
 insomnia
 dilated pupils
 constipation
 decreased sex drive
 loss of appetite
 delayed orgasm and ejaculation
 sleepiness
 feeling that your surroundings are spinning or moving
 These are not all the possible side effects of PRISTIQ. Tell your
healthcare provider about any side effect that bothers you or does not go away. Call your
doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-
1088. For more information on these and other side effects associated with PRISTIQ, talk to
your healthcare provider, visit our web site at www.pristiq.com or call our toll-free number at
1-888-PRISTIQ (774-7847).

8. A “Brief Summary” of PRISTIQ (continued)
 Pfizer, Co. would also have to provide answers to the
following questions to complete their “Brief Summary”:
 …Who should not take the drug?
 …When the drug should not be taken?
 Could you imagine how long a TV Ad would be for PRISTIQ
prior to 1997?

9. A “Brief Summary” of PRISTIQ (continued)
 As you can see, the extensive list of possible serious side
effects and frequently occurring (but not necessarily serious) side
effects of PRISTIQ made it very difficult for pharmaceutical
companies like Pfizer, Co. to market their drugs effectively
with the regulations set out by the FDA.
 While the “Brief Summary” provides consumers with detailed
information about the drugs, it does not provide a balanced
view of risks and benefits, and cannot be presented in a short
advertisement.
 Lets see what this brief summary looks like in a print ad…

11. History of DTC Advertising in the Pharmaceutical
Industry – New Regulations
New FDA regulations, introduced in
1997allowed TV ads to name a pharmaceutical
brand and the condition it treatedwithout the
summary.
Now TV Ads were only required to include a
“major statement” of the most important risks
(without the summary), and
a referral to a source of in-depth information.
This regulation was formerly adopted in 1999.
Source: The U.S Food and Drug Administration

13. Explosion of Direct to Consumer Advertising
Dollars in Billions Spent on Advertising from 1996 to 2010
Dollars in Billions Spent
$6
5.41
5.18
$5 4.65 4.66
4.77
4.43 4.34
$4
3.45
$3 2.82 2.78
2.59
1.92
$2
1.31
0.98
$1 0.7
$0
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Source: Kantar Media. Totals are for 17 measured media: network TV, spot TV, cable TV networks, Spanish-language TV networks, syndicated TV, consumer magazine, Sunday magazine, Spanish-language magazine, local
magazine, newspaper, national newspaper, Spanish-language newspaper, national spot radio, network radio, local radio, outdoor and internet display (excluding search and broadband video).

14. Top 10 Most-Advertised Prescription Drugs
By 2010 U.S. measured-media ad spending in 17 media.
Media Advertiser Rank - 2010
Spending Prescription 2010 (Dollars in 2009 (Dollars total media ad spending
Rank Drug Marketer/Company millions) in millions % Change Primary Conditions (millions - $)
1 Lipitor Pfizer $272.0 $247.1 10.1 High cholesterol 1 - $967.5
2 Cialis Eli Lilly & Co. 220.6 179.2 23.1 Erectile dysfunction 2 - $470.8
Eli Lilly & Co. Mental health,
3 Cymbalta 206.0 182.7 12.7
depression
2 - $470.8
4 Advair GlaxoSmithKline 200.5 183.3 9.4 Asthma, respiratory 4 – $338.6
Bristol-Myers Squibb Mental health,
5 Abilify Co.
155.7 205.7 -24.3
depression
5 - $330.0
Asthma, COPD,
6 Symbicort AstraZeneca 152.2 136.2 11.8
respiratory
3 – $422.7
Mental Health,
7 Pristiq Pfizer 127.4 124.4 2.4
depression
1 – $967.5
Bristol-Myers Squibb
8 Plavix Co.
127.3 149.9 -15.2 Blood Thinner 4 - $338.6
9 Chantix Pfizer 122.2 155.8 -21.5 Smoking 1 - $967.5
10 Lyrica Pfizer 112.2 162.2 -30.8 Diabetes, fibromyalgia 1 - $967.5
Source: Kantar Media. Totals are for 17 measured media: network TV, spot TV, cable TV networks, Spanish-language TV networks, syndicated TV, consumer magazine, Sunday magazine, Spanish-language magazine, local
magazine, newspaper, national newspaper, Spanish-language newspaper, national spot radio, network radio, local radio, outdoor and internet display (excluding search and broadband video).

15. 10 Largest Pharmaceutical Advertisers
By 2010 U.S. measured-media ad spending in 17 media.
Media
Spending 2010 (Dollars in 2009 (Dollars in
Rank Marketer/Company millions) millions % Change Prescription Drug
1 Pfizer $967.5 $1,148.6 -15.8 Lipitor
2 Eli Lilly & Co. 470.8 370.0 27.2 Cialis
3 AstraZeneca 422.7 388.6 8.8 Symbicort
4 GlaxoSmithKline 338.6 311.2 8.8 Advair
5 Bristol-Myers Squibb Co. 330.0 423.6 -22.1 Abilify
6 Merck & Co. 320.6 460.1 -30.3 Singulair
7 Johnson & Johnson 173.7 88,9 95.3 Simponi
8 Allergan 166.6 137.5 21.2 Restasis
9 Abbott Laboratories 143.4 157.5 -9.0 Trillpix
10 Roche Holding 95.9 93.2 3.0 Boniva
Source: Kantar Media. Totals are for 17 measured media: network TV, spot TV, cable TV networks, Spanish-language TV networks, syndicated TV, consumer magazine, Sunday magazine, Spanish-language magazine, local
magazine, newspaper, national newspaper, Spanish-language newspaper, national spot radio, network radio, local radio, outdoor and internet display (excluding search and broadband video).

16. Pharmaceutical Advertising by Medium in 2010
U.S. measured-media ad spending of $4.3 billion for medicines and
pharmaceutical companies.
Internet Syndicated TV
(display) 8% Cable TV networks
Newspapers 13%
Spot TV 5% 7%
2%
Radio
1%
Outdoor
0%
TV Networks
32%
Magazines
32%
Source: Kantar Media. Totals are for 17 measured media: network TV, spot TV, cable TV networks, Spanish-language TV networks, syndicated TV, consumer magazine, Sunday magazine, Spanish-language magazine, local
magazine, newspaper, national newspaper, Spanish-language newspaper, national spot radio, network radio, local radio, outdoor and internet display (excluding search and broadband video).

17. Is Big Pharma spending too much on
traditional Advertising?
 From the previous graphic, we can see that over 50% of
the spending on pharmaceutical ads was for television
and only 5% was for Internet display ads.
 The use of highly-emotional, symptom-driven
advertisements can manipulate consumers by creating false
impressions and mislead consumers instead of educating
them.
 If Pharmaceutical companies are to compete in this
world of convergence, they need to embrace
technology and engage in the consumer
driven, participatory communities of Social Media.

18. Pharmaceutical companies spend 19 times
more on Advertising than R&D
 According to a recent report in BMJ, a medical journal
based in London, pharmaceutical companies are not
putting a lot of resources back into Research and
Development.
 Instead, it's more profitable for them to simply to
create a bunch of products that are only slightly
different from drugs already on the market, the reports
authors said.
 “for every dollar pharmaceutical companies spend on
"basic research," $19 goes toward promotion and
marketing.”
Information provided by The Huffington Post - Pharmaceutical Companies Spent 19 Times More On Self-Promotion Than Basic
Research: Report, by Alexander Eichler.
For more information, visit http://www.huffingtonpost.com/2012/08/09/pharmaceutical-companies-marketing_n_1760380.html

19. With all the money they have been spending on
Advertising, why haven’t more Pharmaceutical
companies invested more efforts into Social
Media?
 Risk.
 Uncertainty.
 Lack of clarity around ROI in social media.
 Lack of comprehensive guidance from the FDA.

20. Risk: Improper Marketing Claims
 Many pharmaceutical companies have been targeted by
federal and state authorities for allegations including
improperly promoting prescription drugs for “off-label”, or
unapproved uses.
 In Social Media, there is a risk of manufacturers being held
responsible for content created by a consumer.
Uncertainty: Regarding Expectations
and Responsibilities
 How do pharmaceutical companies deal with highly
contrained social media tools? (like 140 character limit in
Twitter)
 There is also uncertainty regarding social media policy
outlined by the FDA and and social media giants like
Facebook.

21. August 2011: Facebook changed its privacy
rules: Drug makers can no longer disable posts.
 Facebook now requires all Facebook pages to enable
comments, a policy that was meant to make the site
more interactive, but BigPharma are still weary of the
two-way interaction in social media.
 Some pharmaceutical marketers shut down their pages.
 Others posted warnings and reserve the right to disable
comments.
 Some are taking advantage of social media, like Boehringer
Ingelheim, Sanofi, Novo Nordisk, and AstraZeneca.

22. The FDA releases new guidance for social media
interaction, Dec 30, 2011: “Responding to Unsolicited Requests
for Off-Label Information About Prescription Drugs and Medical Devices.”

23. Example of a Correct Product Claim Ad
 According to the FDA, this is an
acceptable product claim ad that
names a drug, says what condition it
treats, and talks about both its
benefits and its risks. An ad must
present the benefits and risks of a
prescription drug in a balanced
fashion. Balance depends on both
the information in the ad itself and
how the information is presented. In
this ad, the benefits and risks are
presented to give a balanced
impression of the drug.
Source: The U.S. Food and Drug Administration

24. Example of an Incorrect Product Claim Ad
There are 4 major problems with this ad:
 The ad misleadingly suggests that Arbitraer is
approved to treat children by showing an image of a
young girl. Remember that these ads must suggest
only uses that have been approved by FDA.
 The ad does not present a "fair balance" of
information about the drug's risks compared with its
benefits because the ad minimizes the important
risks of Arbitraer. The risks appear in much smaller
type than the benefits and are placed in a corner of
the ad far from the benefits and are likely to be
overlooked.
 The ad makes false and misleading claims about
Arbitraer. It is not approved to treat asthma
symptoms. Also, no studies support the claims that
Arbitraer works "in no time," and that most allergy
sufferers think Arbitraer is "the best." All ad
information needs to be supported by well-designed
studies.
 The ad does not contain the required "brief
summary" of information that includes all the risks
listed in the FDA-approved prescribing information.
Source: The U.S. Food and Drug Administration

25. BigPharma’sBigFines: Six recent multi-million dollar fines
that drug companies have agreed to pay for illegally promoting
prescription drugs
Pfizer AstraZeneca Abbott
Eli Lilly SEPT 2009
Merck
APRIL 2010 MAY 2012
JAN 2009 Fined NOV 2011
Fined Fined
Fined Fined
$2.3 billion
for misbranding for illegally for illegal
for off-label the painkiller for illegal
promoting the promotion of the
promotion of anti- Bextra with anti-psychotic drug promotion of the
anticonvulsant
psychotic Zyprexa “intent to defraud Seroquel. painkiller Vioxx.
drug Depakote
or mislead”
Source: Department of Justice Information compiled by Lena Groeger, ProPublica, July 3, 2012

26. Now looking back at Ad spending:
Dollars in Billions Spent on Advertising from 1996 to 2010 Dollars in Billions Spent
$6 5.41
5.18
4.65 4.66 4.77
$5 4.43 4.34
$4 3.45
2.82 2.78
$3 2.59
1.92
$2 1.31
0.98
$1 0.7
$0
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
 The launch of a consumer-
friendly, information driven
website founded in
1996, grew exponentially
during this tough, digital
revolution while many
pharmaceutical companies
have failed to harness.
WebMD now gets more than
86.4 million views per
month, and is the leading
health portal in the United
States.

27. Source: WebMD.com

28. How are consumers using the internet
to find health information?
Medical Websites and
Informational Websites
are the highest viewed health
information sites, receiving
75% of all visitors seeking
health info.
Source: Pharma Marketing Blog

29. Are pharmaceutical companies falling short in
connecting with the engaging audience?
 Tom Schwenger, global managing director for Accenture’s Life Sciences
Sales & Marketing practice said,
“Pharmaceutical companies that
embrace innovations such as social networking and communications
via mobile devices and integrate and align their communication
strategy across multiple channels will be positioned to have a much
greater influence on their patients’ choices and
consequently, realize significant increases in revenue, profitability
and sustained competitive advantage.”
 “While pharmaceutical companies are methodical in manufacturing
their products, there is a clear disconnect in how they communicate
with their patients,” Schwenger said. “Companies need to
reevaluate their marketing campaigns to ensure they are integrated
across all patient touch-points and channels to meet customer
demand for health solutions, increase trust and brand loyalty and
enhance customer perceptions.”
Study provided by Accenture, Nov. 2010
• The study was based on an online survey conducted by Accenture of 852 adult consumers in the U.S. between August 30, 2010 and September 3, 2010. The survey
sample is representative by gender, age, and geography of the U.S. population. Consumers polled indicated they or someone in their household was currently taking
prescribed medications.
• For more information visit Accenture’s Newsroom: http://newsroom.accenture.com/article_display.cfm?article_id=5096

30. How can Pharmaceutical Companies take
advantage of Social Media?
 There will continue to be significant, disruptive innovations in the
pharmaceutical sales and marketing model within the next five
years driven by the creation of a more customer-focused business
model, further cost-cutting initiatives and the quest by companies
to gain a more competitive edge.
 Pharmaceutical companies must not only provide the right
information, but upgrade their websites to create a more
dynamic, interactive experience, demonstrate an understanding of
their patients’ needs, provide holistic solutions and clearly
reinforce their brand identity in a two-way dialogue.
Study provided by Accenture, Nov. 2010
• The study was based on an online survey conducted by Accenture of 852 adult consumers in the U.S. between August 30, 2010 and September 3, 2010. The survey
sample is representative by gender, age, and geography of the U.S. population. Consumers polled indicated they or someone in their household was currently taking
prescribed medications.
• For more information visit Accenture’s Newsroom: http://newsroom.accenture.com/article_display.cfm?article_id=5096

31. Pfizer in Social Media Today
9 Facebook
Pages
14 Youtube 1 SlideShare
Channels
10 Twitter Pfizer 1 LinkedIn
feeds
Source: Pfizer in Social Media - http://www.pfizer.com/news/social_media/social_media.jsp

32. Boehringer Ingelheim – Drive4COPD
Boehringer Ingelheim Pharmaceuticals started a public health
initiative in 2010. This campaign’s message was to get screened.
• Twitter, Facebook, Youtube and Flickr accounts were
launched, as well as a clever virtual Twitter race that put
celebrity ambassadors Danica Patrick and Patty Loveless on a
race to see who could drive the most visitors to the
campaign’s online screener.
• More than 2.5 million people have completed the online
screening.
•Drive4COPD Screener
Source: Innovative campaings pushed pharma social media forward, by Deanna Pogorelc, June 4, 2012. Medcitynews.com

33. Sanofi Diabetes U.S.
 Sanofi Diabetes experimented with new ways to engage
patients in the sticky area of social media.
 They released a Discuss Diabetes Blog, a Facebook page, a
Twitter account, and free online education session for
patients.
 Sanofi has also improved its transparency by staying open
in its social media presence and sharing insights on how
community engagement has impacted the company.
 In April, Sanofi launched Diabetapedia, which is a
searchable resource for common diabetes terms.
Sanofi community engagement information.
Source: Innovative campaings pushed pharma social media forward, by Deanna Pogorelc, June 4, 2012. Medcitynews.com

34. Novo Nordisk – Race with Insulin
 Milestone in the evolution of pharmaceutical social
media. Rather than pushing press releases and company
news, Novo Nordisk created a Twitter account in 2009 to
promote IndyCar driver Charlie Kimball to reach its
target audience.
 Research conducted by Novo Nordisk found IndyCar fans to
be 23% more likely to have diabetes.
 Kimball used the @racewithinsulin Twitter account to tweet
about racing, life with type 1 diabetes and using Novo
Nordisk’s products to manage the disease.
 This was a groundbreaking leap into pharmaceutical social
media with lack of guidance and experience.
Source: Innovative campaings pushed pharma social media forward, by Deanna Pogorelc, June 4, 2012. Medcitynews.com

35. AstraZeneca – Prescription assistance program
 AstraZeneca kept their Facebook open while others
removed theirs after Facebook’s open-comment policy
change.
 They took a big step on Twitter by hosting a Twitter chat
about patient prescription programs using the
#rxsavehashtag.
 The tweet chat was created to get people talking about the
Prescription Assistance Program, and engage to help find
ways to reach more patients who are eligible for the
program.
Source: Innovative campaings pushed pharma social media forward, by Deanna Pogorelc, June 4, 2012. Medcitynews.com

36. Other Ground-breaking examples of Pharmaceutical
Companies that harness Social Media
 Johnson & Johnson launched a YouTube channel in May
2008, to encourage 2-way engagement.
 The National Multiple Sclerosis Society has over 135,000
Facebook Likes.
 Christine O’Connell created a “Shame on you, KV
Pharmaceutical and CEO Greg Divis” Facebook page because
she was so angry at the increase of drug prices.
 KV shares dropped significantly.
 Oncology Pharma’sLinkdIn groups have saved lives through
their connections – they sourced doctors to save inoperable
tumors.
Source: Social Media in the Pharmaceutical Industry, by Hannah Blake. July 2012.PharmaPhorum – Link to Article

37. The Future of Pharmaceuticals and Social Media :
The Path Forward
 How can Pharmaceutical Companies benefit from using
Social Media?
 Marketing their products more effectively
 Negligible costs for maintaining social media
 Increased brand awareness, greater market reach, quicker
and more comprehensive feedback.
 Social media gives all firms the chance to build and
identify new opportunities, gain insight about new
products, develop more targeted marketing practices, and
better understand market needs.
Source: The Path Forward by Kassity Liu. Jolt Digest, Harvard Journal of Law & Technology. Link to article.

38. The Future of Pharmaceuticals and Social Media :
Advancing Public Health and Awareness
 Social media can be used:
 To advance public health and provide benefits to patients
and the medical community.
 As an important source for health care information, with
nearly 2/3 of all American adults looking on line for health
information.
 To collaborate and learn from other pharmaceutical
companies that have taken a more proactive approach into
this evolving area of technology.
Source: The Path Forward by Kassity Liu. Jolt Digest, Harvard Journal of Law & Technology. Link to article.