Direct-to-Consumer Prescription Drug
Advertising in the United States:
Background, Research, and the Current Environment
Kathryn J. Aikin, Ph.D.
Division of Drug Marketing, Advertising and Communications
US Food and Drug Administration
International Seminar on Drug Advertising
Brasilia, Brazil
April 5, 2005
Overview of Talk
 Legal Requirements
 Types of DTC
 Evolution of DTC
 “Adequate Provision” in Broadcast Ads
 General Considerations in DTC
 Basis for Enforcement Actions
 FDA Survey Research Findings
 Current Environment and Recent
Enforcement Actions
Jurisdiction/Legal Basics
 No laws or regulations ever prohibited
promoting prescription drugs to consumers (in
general or for specific products or drug classes)
 Regulatory focus is on the content of the
materials NOT their general existence
Jurisdiction/Legal Basics
 Law prohibits requiring preapproval of any ad
except under “extraordinary circumstances”
-- post hoc monitoring process
-- still, many manufacturers voluntarily request our
comments prior to use
Requirements for Ads
Per FDA regulations issued in late 1960’s, ads:
 Must not be false or misleading
 Must present “fair balance” between benefits
and risk information
 Must disclose “material” facts in light of claims
made about product
What Does this Mean?
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Accurately communicate indication(s)
including context for any claim
Communicate most important risks in a
manner reasonably comparable to benefits
(presentation and language)
Cannot omit important information
In plain language this means  Ads must
communicate an accurate and balanced
picture of the drug product
Some Sources of Product-Specific
Health Information for Patients
 Healthcare Provider
 Patient Package Insert
 Advertising
 Brief Summary
 Internet
 Other Sources
Disease Awareness
Reminder
Product Claim
How DTC Evolved
 Up to 1980’s: consumer communications
through “learned intermediary”
 1980’s: saw 1st DTC ads and fallout
--1983-1985: FDA voluntary moratorium
--1985: lifted, regulations provide “sufficient
safeguards to protect consumers”
 1990’s: print ads proliferated
 mid 1990’s: broadcast ads enters mix
Addressing “Adequate Provision”
 Guidance (1997 draft; 1999 final)
 no change to regulations
 provided one possible interpretation of
“adequate provision” given current technology
and marketplace
 Reinforces underlying requirements
 Encourages consumer-friendly information
“Adequate Provision”
 Assuming diverse audience, need multiple
sources of product information
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toll-free telephone contact number
website address
concurrently running print ads
reference to health care providers
Types of DTC Promotion
 Disease Awareness
 Reminder ads/labeling
 Product claim
Types of DTC Promotion
 Disease Awareness
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disease discussion … “see your doctor”...
consistently encouraged, important for underdiagnosed, under-treated health conditions
not drug ads, so not covered by FFD&CA
recent draft guidance clarifies FDA’s position
on these types of ads
Types of DTC Promotion
 Reminder ads/labeling
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exempted from risk disclosure requirements
includes product name, but no representations
beyond dosage form, packaging, price info
not for products with especially serious
(boxed) warnings
Types of DTC Promotion
 Product claim
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claims or representations trigger disclosure
requirements for accuracy and balance
risk disclosure requirement in regulations
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“brief summary” for print ads
“adequate provision” for broadcast ads
full product labeling for promotional labeling
General Considerations in
DTC Advertising
 Accurate communication of indication(s)

Limitations on indication(s)
Relevant patient population
 Concomitant therapies/treatments
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Likelihood of benefit(s)
General Considerations in
DTC Advertising
 Disclose Most Important Risks
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“In brief summary” for print ads
“Major” risks for broadcast ads + “adequate provision”
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Boxed warnings
Bolded warnings
Significant precautions/drug interactions
Frequent & significant side effects
Contraindications (relevant to patients)
Risk Disclosure
 Print ads need information “in brief summary”
about risks and effectiveness

most important risks comparably prominent to
effectiveness claims as “fair balance”
 Regulations require that print ads must
disclose all risks

February 2004 Draft Guidance provided
alternatives to the current “brief summary” in
effort to have information better conveyed to
consumers
Risk Disclosure
 Broadcast ads need:
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most important risks disclosed in ad itself (in
audio at least) “major statement”
access to either all risks or “adequate provision”
for disseminating product labeling (PI)
General Considerations in
DTC Advertising
 “Fair Balance” of Risks and Benefits
 Prominence of the presentation
 Amount of information
 Language
 Necessary context for benefit claims/risks
 Should not undermine the role of the healthcare
provider
 Disclose prescription status
Additional Considerations in
Product Claim Ads
 Overstatement of efficacy, especially if
relatively low
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“freedom from,” “controls,” “proven
protection,” graphics suggesting significant
impact, other hyperbole
sometimes context can help, other times it
can’t
 Implied unsubstantiated outcome claims
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“relaxed,” “confident,” “changed my life”
Additional Considerations in
Reminder Ads
 Avoid anything --verbal or visual -- that makes
a claim about the product, e.g.,
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“why suffer through another day?”
“most prescribed of its kind”
implied fixing of something that is broken
clear suggestion of improved quality of life
clear suggestion of patient population (all children, all
women, all people with some problem)
reference to particular type of specialist
Common Problems in Proposals
and Final Submissions
 Minimization or lack of risk information
 missing content
 presentation (minimization, comparability)
 Misleading communication of the indication or
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overstatement of efficacy
Unsubstantiated comparative claims
Misleading visuals and graphics
Distracting modalities or illegible SUPERs
Rx status or role of healthcare provider minimized
Inadequate mechanism for ensuring
dissemination of product labeling
Does DTC advertising...
 Increase demand for advertised drugs?
 Cause patients to pressure doctors for
advertised drugs?
 Cause inappropriate prescribing?
 Increase the price of drugs or the cost of
health care?
 Harm the relationship between patients and
doctors?
 Is DTC advertising appropriate at all?
FDA Surveys
 Look more closely at impact of DTC
advertising on doctor-patient relationship
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Two consumer surveys (1999 and 2002)
One physician survey (2002)
1999 and 2002 Consumer Surveys:
Methodology
 1999
 2002
 National probability
 National probability
sample conducted by
telephone interview
 1,081 respondents, 960
who had visited a
doctor in the last three
months for a problem of
their own
sample conducted by
telephone interview
 943 respondents who
had visited a doctor in
the last three months
for a problem of their
own
2002 Physician Survey:
Methodology
 Random Sample from American Medical
Association Physician Masterfile
 250 General Practitioners
 250 Specialists in areas targeted by DTC
 Dermatology
 Allergy/Pulmonology
 Endocrinology
 Psychiatry
Does DTC advertising increase
demand for advertised drugs?
 DTC not primary driver of visits to doctor
 DTC plays a role in generating questions for
doctor
 Patients still use their doctors as #1
information source when looking for more
information about a drug or treatment

Pharmacists, nurses also highly ranked as
sources
Does DTC advertising cause patients to
pressure doctors for advertised drugs?
 Some patients do expect a prescription because
of a DTC ad
 Asking about prescription drugs constant across
time
 Brand-specific requests are likely to be
accommodated
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Patients who ask about a brand are more likely to be prescribed
that brand than patients who ask in general
General Practitioners are more likely to prescribe a requested
brand than Specialists
General Practitioners report feeling more pressured to prescribe
Does DTC advertising cause
inappropriate prescribing?
 Vast majority of patients who ask about a
brand have the condition that drug treats
 Among physicians who did not prescribe
requested drug, most common reasons were:
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drug not right for patient
different drug more appropriate
Does DTC advertising increase the price
of drugs or the cost of healthcare?
 Patients rarely discuss cost of drugs with
doctor
 Certain groups are more likely to discuss cost:
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Women
Patients in poor health
Patient taking one or more prescription drugs
Patients without prescription drug payment plan
Does DTC advertising harm the
relationship between patients and doctors?
 Patients report their doctors generally respond
positively to questions
 Greater percentage of doctors say patient having
seen a DTC ad had positive impact on interaction,
as opposed to negative impact
 General Practitioners report more negative beliefs
about potential negative effects of DTC ads than
Specialists
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Physicians are evenly divided in opinions about overall impact of
DTC ads on patients and practice- 1/3 positive, 1/3 no effect, 1/3
negative
General Practitioners report a more negative overall impact of DTC
ads on patients and practice than Specialists
Is DTC advertising appropriate at all?
 DTC ads increase awareness of possible
treatments
 DTC ads do not convey information about risks
and benefits equally well
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Physicians believe patients understand benefits
much better than risks
Physicians believe DTC ads confuse patients
about relative risks and benefits of drugs
Patient attitudes about many aspects of DTC
advertising have become less positive over time
Current Environment
 Continued increase in DTC promotion
spending
 Concern about changing tone in ads
 Concern about presentation of risks
Are the winds of change on the way?
Number of Disseminated Promotional
Pieces Submitted 2003 and 2004
60.000
52.848
50.000
40.000
38.081
37.526
32.022
30.000
20.000
10.000
6.908 8.417
4.423 6.059
0
2003
Mixed
2004
Consumer
Professional
Total
Number of Broadcast Ads Submitted
1999-2004
700
628
600
486
500
443
485
376
400
293
300
200
474
295
242
201
188
248
191
128
105
311
163
143
100
0
1999
2000
Proposed
2001
2002
Disseminated
2003
Total
2004
Draft Brief Summary Guidance
 Regulations require that the “brief summary” include
“each specific side effect and contraindication” (i.e.,
all risk concepts)
 Manufacturers historically complied by reprinting riskrelated sections of product labeling
 Verbatim reprinting is not required
 Draft guidance describes consumer-friendly options
for brief summary in DTC ads
Enforcement Actions
 Kaletra Untitled Letter
 Taxotere Warning Letter
 Seasonale Untitled Letter
Kaletra Untitled Letter
 Print ad and restroom poster
 Indicated for use in combination with other
antiretroviral agents for the treatment of HIVinfection
 Contraindications
 Warnings
Kaletra
Print Ad
Kaletra Untitled Letter
 Ad and poster did not contain the indication
or risk information
 Not aware of substantial evidence to support
5-year claims for:
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survival
good health
undetectable HIV RNA levels
disease control
Taxotere Warning Letter
 Three DTC print ads
 Limited indications for certain types of breast
and lung cancer
 Boxed warning for severe and potentially lifethreatening adverse reaction
Taxotere Warning Letter
 Overstated survival benefits: Headline: “The next
move may be the key to survival”
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Proven survival differences were at best several
months and were only observed in specific populations
Other drugs with proven survival benefits
 Unsupported outcomes claims
 Stay involved in important aspects of your life
Taxotere Warning Letter
 Omission of risk information
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Boxed warning information on risk of life-threatening
infections, severe allergic reactions, and severe fluid
retention
Certain common side effects
 Minimization of risk information
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Risk info lacked visual prominence
Disclosure began “Like all anticancer agents, there
are side effects…”
Seasonale Untitled Letter
 Product claim TV ad
 Indicated as an extended-cycle OC
 91 days: 84 active tablets and 7 inert
 Warnings
 The usual OC warnings plus
 Bleeding irregularities: “the convenience of fewer
planned menses (4 per year instead of 13) should be
weighed against the inconvenience of increased
intermenstrual bleeding and/or spotting”
 Warning also contained in patient labeling
Seasonale Untitled Letter
 Failure to reveal material facts in light of the claim
“4 periods a year”
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Patients using Seasonale may experience
breakthrough bleeding or spotting for up to one year
Breakthrough bleeding may be up to the amount
similar to a regular period
Total days of bleeding and spotting are similar in
number for Seasonale subjects as for those on
conventional OCs
Seasonale Untitled Letter
 Minimization of risk
 Suggested there was a consensus
among medical experts that there are no
adverse health effects of having only four
periods a year
 Competing visuals
 Fast-paced scene changes
 Other competing modalities, such a
background music and SUPERS
Where to Find Recent Guidances
 Consumer-Directed Broadcast Ads:
 http:// www.fda.gov/cder/guidance/1804fnl.htm
 “Help-Seeking” and Other Disease Awareness
Communications:
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http://www.fda.gov/cder/guidance/6019dft.pdf
 Brief Summary: Disclosing Risk Information in
Consumer-Directed Print Ads:
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http://www.fda.gov/cder/guidance/5669dft.pdf
Other Online FDA Resources
 General FDA information:
 http://www.fda.gov
 DDMAC home page:
 http://www.fda.gov/cder/ddmac.htm
 Untitled and Warning Letters:
 http://www.fda.gov/cder/warn/index.htm
Contact info: aikink@cder.fda.gov