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DirecttoConsumer Advertising of Prescription Drugs: Looking Back, Looking Forward

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Title: DirecttoConsumer Advertising of Prescription Drugs: Looking Back, Looking Forward


1
Direct-to-Consumer Advertising of Prescription
DrugsLooking Back, Looking Forward
  • Kathryn J. Aikin, Ph.D.
  • Division of Drug Marketing, Advertising
  • and Communications, FDA
  • Society for Womens Health Research
  • October 25, 2005

2
Talk Outline
  • Requirements for pharmaceutical ads
  • How DTC evolved
  • FDA survey findings
  • Whats next?

3
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
4
Requirements for Ads
  • Per FDA regulations issued in late 1960s, 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

5
What Does this Mean?
  • Accurately communicate indication(s) including
    context for any claim
  • Limitations on indication(s)
  • Relevant patient population
  • Concomitant therapies/treatments
  • Likelihood of benefit(s)
  • Communicate most important risks in a manner
    reasonably comparable to benefits (presentation
    and language)
  • Cannot omit important information
  • In plain language ? Ads must communicate an
    accurate and balanced picture of the drug product

6
How DTC Evolved
  • Up to 1980s consumer communications through
    learned intermediary
  • 1980s saw 1st DTC ads and fallout
  • --1983-1985 FDA voluntary moratorium
  • --1985 lifted, regulations provide sufficient
    safeguards to protect consumers
  • 1990s print ads proliferated
  • mid 1990s broadcast ads enters mix

7
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?

8
FDA Surveys
  • Look more closely at impact of DTC advertising on
    doctor-patient relationship
  • Two consumer surveys (1999 and 2002)
  • One physician survey (2002)

9
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

Note results not weighted and therefore not
directly projectable
10
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

Note results not weighted and therefore not
directly projectable
11
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

12
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

13
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

14
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

15
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

16
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

17
What is Next?
18
PhRMA DTC Guidelines
  • Follow the existing regulations
  • More disease awareness
  • No broadcast reminders
  • Voluntary pre-submission to DDMAC

19
Upcoming FDA Public Meetings
  • Direct-to-Consumer Promotion of Medical Products,
    November 1-2, 2005
  • opportunity for broad public participation and
    comment on direct-to-consumer (DTC) promotion of
    regulated medical products
  • http//www.fda.gov/cder/ddmac/dtc2005/default.htm
  • CDER's Current Risk Communication Strategies for
    Human Drugs, December 7-8, 2005
  • to obtain public input on CDERs current risk
    communication tools and obtain greater
    understanding of the strengths and weaknesses of
    CDERs existing risk communication
  • http//www.fda.gov/cder/meeting/RiskComm2005/defau
    lt.htm

20
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

21
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 kathryn.aikin_at_fda.hhs.gov
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