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