DirecttoConsumer Prescription Drug Promotion

1
Direct-to-Consumer Prescription Drug Promotion

• Nancy M. Ostrove, Ph.D.
• Division of Drug Marketing, Advertising, and
  Communications
• Food and Drug Administration

2
Overview

• What we know
• law
• history
• stakeholder concerns
• enforcement problem areas
• consumer/patient perceptions
• What we dont know
• broad effects on the public health

3
Background Facts

• No laws or regulations ever prohibited promoting
  prescription drugs to consumers
• Law requires advertisements to include
  information in brief summary about products
  risks and benefits
• Law generally prohibits preclearance

4
Types of Advertisements - 1

• Help-seeking (See your doctor, disease
  oriented)
• these are not drug ads

5
Types of Advertisements - 2

• Reminder
• regulations specifically exempt from disclosure
  requirements
• include name of product, but no representations
  beyond dosage form and packaging, price
  information
• designed to remind knowledgeable persons of
  existence of product

6
Types of Advertisements - 3

• Product-claim -- includes
• name and quantitative information
• product use (indication)
• optionally, other substantiated claims
• risk disclosure (requirements vary as a function
  of whether print or broadcast)

7
Law Focuses on Content of Ads

• Cant be false or misleading
• Must present fair balance between benefits and
  risk information
• Cant omit material facts
• Plain language meaning Ads must communicate
  an accurate and balanced picture of the product

8
If the law allowed ads to be directed to
consumers, why didnt we see them until
relatively recently?
9
Things Changed

• Consumer empowerment
• desire for involvement in own care
• active information seeking
• Aging baby-boomer population
• selves, children, parents
• Managed Care
• Increasing focus on First Amendment

10
Evolution of DTC

• Up to 1980s -- learned intermediary only
• 1983 - 1985 -- voluntary moratorium
• 1985 - regulations provide sufficient safeguards
  to protect consumers
• 1990s - steady increases in print promotion
• mid 1990s - broadcast increasingly enters mix

11
Broadcast Environment

• Static -- sponsor uncertainty regarding
  requirement for brief summary
• Adequate provision for providing labeling
  always allowed
• FDA never gave guidance on how to
• Major risks required to be disclosed regardless
  of mechanism

12
Result was a confusing broadcast environment --
more and more uninformative reminder
advertisements
13
Adequate Provision Guidance

• How to reach diverse group of consumers?
• Sponsors had some suggestions
• 1997 draft gave possible approach, finalized in
  1999
• reference to health care provider
• print ads/brochures
• telephone contact number
• internet site

14
Perspectives
15
Stakeholder Perspectives - 1

• DTC is good -- FDA should not over-regulate
• PhRMA, individual pharmaceutical sponsors
• ad agencies and associations
• communications groups
• media providers (print, TV, radio, internet)
• Federal Trade Commission (FTC)

16
Stakeholder Perspectives - 2

• Mixed bag -- DTC may have some benefits but FDA
  should strictly regulate
• some consumer/patient groups (e.g., National
  Consumers League)
• some health care professional associations (AMA,
  ACP/ASIM, APhA)
• generally want FDA to preapprove promotional
  materials

17
Stakeholder Perspectives - 3

• DTC is bad -- should be stopped
• some consumer groups (e.g., Public Citizen,
  Center for Medical Consumers, National Womens
  Health Network)
• managed care (AMCP)
• historically, generic manufacturers
• Drug Enforcement Administration (DEA)

18
Focus of Arguments

• Patient-physician interaction/relationship
• Prescribing behavior
• Patient knowledge about drugs
• Product costs

19
Current Situation

• Close surveillance and quick enforcement
• Encourage compliance -- cooperate with voluntary
  requests for pre-review and comment
• Assessing impact

20
Enforcement

• Product efficacy claims
• broadening indication, patient population
• overstating or guaranteeing efficacy
• implying use without disclosing risk
• Disclosure of product risks
• content
• presentation (minimization fair balance)
• Adequate provision mechanism

21
What is DTCs Impact?

• Little research until relatively recently
• cost concerns (correlational analyses)
• effects on physician/patient relationship
  (self-report surveys)
• FDA, Prevention, TIME Inc., NCL, AARP
• effects on patients knowledge about drugs
  (experimental designs, surveys)
• effects on prescribing behavior (?)

22
FDAs Research

• Patient/Physician interaction
• is DTC influencing patient behavior?
• 2000 - national survey of patients behaviors and
  attitudes
• www.fda.gov/cder/ddmac/research.htm

23
Methodology

• National probability sample
• focus on patients visiting doctor in last 3
  months about a problem of their own
• Telephone interview (n1,081)
• Final sample
• 960 who had seen doctor in last 3 months
• 121 who had not

24
Demographics

• More females than males especially among those
  who had seen a doctor
• 65 vs. 55
• Similar ethnicity and overall education among
  those who had and had not seen a doctor

25
Self-Reported Health
26
Do Respondents Recall Seeing Advertisements?

• Asked whether they had seen an advertisement for
  a prescription drug in last 3 months
• 72 of those who had seen a doctor
• 69 of those who had not seen a doctor
• Not inconsistent with 1999 Prevention survey
• 81 had seen an ad (no time limit)

27
Where Was Advertisement Seen or Heard?
(Multiple responses accepted)
94
66
29
28
17
9
n 688
28
What Information is Recalled from TV Ads?
n688
29
Information Seeking in Response to an Ad
51
41
Has an ad for a prescription drug ever caused you
to look for more information, for example, about
the drug or about your health?
30
Sources of Information Cited

• Mostly from health care professionals
• own doctor (81), pharmacist (52), nurse
  (33)
• Reference book (36)
• Friend, neighbor, or relative (30)
• Toll-free number, internet (both 18)
• Other print sources (magazine - 14, newspaper -
  7)

31
How Many Read the Brief Summary?
n688
32
What if Especially Interested in the Product?
n688
33
Patient/Physician Interaction?

• Patients report seeing their doctors for the
  traditional reasons
• time for checkup (53)
• feeling ill (42)
• had symptoms (41)
• DTC not directly causing large numbers of visits
• read/saw something (2)

34
DTC Encouraging Discussion?
Has an ad ever caused you to ask a doctor about a
medical condition or illness you hadnt
previously talked about?
35
Awareness Influences Asking
36
How Did Doctor React?
81
79
71
4
Which of these possible reactions did your doctor
have when you asked about the drug?
n
220
37
Feelings About Doctors Reaction
n220
38
What Did Doctor Do?
50
32
29
15
14
12
Did your doctor do one or more of the following?
n 220
39
Reason(s) Given for Not Prescribing Drug

• For 59 who didnt get requested drug prescribed,
  the doctor said why (n65)
• not right for patient 48
• wanted patient to take different drug 35
• side effects patient didnt know 29
• patient didnt have condition 23
• patient didnt need prescription drug 20
• patient could use OTC drug 12
• less expensive drug available 8

40
Trend Data

• Annual national telephone surveys by Prevention
  magazine since 1997
• No change in percentage of patients asking about
  a specific prescription medicine as function of
  DTC promotion
• despite large increases in funding of DTC
  promotion and in television advertising

41
DTC-Related Attitudes - 1(among patients)

• Prescription drug advertisements
• help make me aware of new drugs 86
• give enough information for me to decide whether
  I should discuss with MD 70
• help me have better discussions with my MD about
  my health 62
• Ads make it seem like a MD is not needed to
  decide if drug is right for me 24

42
DTC-Related Attitudes - 2(among patients)

• Prescription drug advertisements
• help me make better decisions about my
  health 47
• make the drugs seem better than they really are
  58
• do not give enough information about
• possible benefits and positive effects 49
• possible risks and negative effects 59

43
Summary

• Patients visiting doctors for traditional reasons
• time for checkup, symptoms, feeling ill
• DTC not causing large numbers of visits
• DTC appears to work
• awareness associated with discussing prescription
  medicine/specific brand with doctor
• prompts information-seeking and asking about
  conditions not previously discussed

44
Summary

• Patients think doctors reacting well to
  discussion about specific products
• Patients think doctors denying products where
  appropriate many doctors providing reasons for
  denial
• Patients see benefits as well as risks associated
  with DTC advertisements

45
Limitations of Existing Research

• Survey data self-report -- subject to recall and
  other biases
• Correlational data subject to causality problem
• Experimental studies to date focused on narrow
  issues of knowledge of particular products --
  used small samples
• Meaning of content analyses?

46
Remaining Questions

• Regarding public health Is DTC causing health
  care professionals to prescribe inappropriately?
• Regarding regulation How can DTC ads best
  communicate drugs relative benefits and risks