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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 AdministrationInternational Seminar on Drug Advertising
Brasilia, BrazilApril 5, 2005
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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
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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
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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
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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
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What Does this Mean?
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
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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
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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
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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
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“Adequate Provision”
Assuming diverse audience, need multiple sources of product information toll-free telephone contact number website address concurrently running print ads reference to health care providers
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Types of DTC Promotion
Disease Awareness Reminder ads/labeling Product claim
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Types of DTC Promotion
Disease Awareness disease discussion … “see your doctor”... consistently encouraged,
important for under-diagnosed, 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
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Types of DTC Promotion
Reminder ads/labeling 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
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Types of DTC Promotion
Product claim claims or representations trigger disclosure
requirements for accuracy and balance risk disclosure requirement in regulations
“brief summary” for print ads “adequate provision” for broadcast ads full product labeling for promotional labeling
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General Considerations in DTC Advertising Accurate communication of indication(s)
Limitations on indication(s) Relevant patient population Concomitant therapies/treatments
Likelihood of benefit(s)
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General Considerations in DTC Advertising
Disclose Most Important Risks “In brief summary” for print ads “Major” risks for broadcast ads + “adequate provision”
Boxed warnings Bolded warnings Significant precautions/drug interactions Frequent & significant side effects Contraindications (relevant to patients)
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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
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Risk Disclosure
Broadcast ads need: 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)
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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
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Additional Considerations in Product Claim Ads
Overstatement of efficacy, especially if relatively low “freedom from,” “controls,” “proven
protection,” graphics suggesting significant impact, other hyperbole
sometimes context can help, other times it can’t
Implied unsubstantiated outcome claims “relaxed,” “confident,” “changed my life”
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Additional Considerations in Reminder Ads
Avoid anything --verbal or visual -- that makes a claim about the product, e.g., “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
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Common Problems in Proposals and Final Submissions Minimization or lack of risk information
missing content presentation (minimization, comparability)
Misleading communication of the indication or 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
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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?
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FDA Surveys
Look more closely at impact of DTC advertising on doctor-patient relationship Two consumer surveys (1999 and 2002) One physician survey (2002)
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1999 and 2002 Consumer Surveys: Methodology 1999 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
2002 National probability
sample conducted by telephone interview
943 respondents who had visited a doctor in the last three months for a problem of their own
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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
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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
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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 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
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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: drug not right for patient different drug more appropriate
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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:
Women Patients in poor health Patient taking one or more prescription drugs Patients without prescription drug payment plan
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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 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
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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 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
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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?
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Number of Disseminated Promotional Pieces Submitted 2003 and 2004
6.9084.4238.417
6.059
37.52632.022
52.848
38.081
0
10.000
20.000
30.000
40.000
50.000
60.000
2003 2004
Mixed Consumer Professional Total
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Number of Broadcast Ads Submitted1999-2004
143163191
128
201188
485
311295248242
105
628
474486
376
443
293
0
100
200
300
400
500
600
700
1999 2000 2001 2002 2003 2004
Proposed Disseminated Total
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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 risk-related sections of product labeling
Verbatim reprinting is not required Draft guidance describes consumer-friendly options
for brief summary in DTC ads
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Enforcement Actions
Kaletra Untitled Letter Taxotere Warning Letter Seasonale Untitled Letter
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Kaletra Untitled Letter
Print ad and restroom poster Indicated for use in combination with other
antiretroviral agents for the treatment of HIV-infection
Contraindications Warnings
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Kaletra Print Ad
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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: survival good health undetectable HIV RNA levels disease control
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Taxotere Warning Letter
Three DTC print ads Limited indications for certain types of breast
and lung cancer Boxed warning for severe and potentially life-
threatening adverse reaction
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Taxotere Warning Letter
Overstated survival benefits: Headline: “The next move may be the key to survival” 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
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Taxotere Warning Letter
Omission of risk information Boxed warning information on risk of life-threatening
infections, severe allergic reactions, and severe fluid retention
Certain common side effects
Minimization of risk information Risk info lacked visual prominence Disclosure began “Like all anticancer agents, there
are side effects…”
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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
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Seasonale Untitled Letter
Failure to reveal material facts in light of the claim “4 periods a year” 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
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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
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Where to Find Recent Guidances
Consumer-Directed Broadcast Ads: http:// www.fda.gov/cder/guidance/1804fnl.htm
“Help-Seeking” and Other Disease Awareness Communications: http://www.fda.gov/cder/guidance/6019dft.pdf
Brief Summary: Disclosing Risk Information in Consumer-Directed Print Ads: http://www.fda.gov/cder/guidance/5669dft.pdf
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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: [email protected]