Download Regulating Consumer-Directed Rx Drug Promotion

Direct-to-Consumer Prescription
Drug Promotion
Nancy M. Ostrove, Ph.D.
Division of Drug Marketing,
Advertising, and Communications
Food and Drug Administration
Overview
 What
we know
– law
– history
– stakeholder concerns
– enforcement problem areas
– consumer/patient perceptions
 What
we don’t know
– broad effects on the public health
Background Facts
 No
laws or regulations ever prohibited
promoting prescription drugs to consumers
 Law requires advertisements to include
“information in brief summary” about
product’s risks and benefits
 Law generally prohibits preclearance
Types of Advertisements - 1
 Help-seeking
(“See your doctor,” disease
oriented)
– these are not drug ads
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
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)
Law Focuses on Content of Ads
 Can’t
be false or misleading
 Must present “fair balance” between
benefits and risk information
 Can’t omit “material” facts
Plain language meaning: Ads must
communicate an accurate and balanced
picture of the product
If the law allowed ads to be
directed to consumers, why
didn’t we see them until
relatively recently?
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
Evolution of DTC
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
 Up
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
Result was a confusing
broadcast environment -more and more uninformative
“reminder” advertisements
“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
Perspectives
Stakeholder Perspectives - 1
 DTC
is good -- FDA should not overregulate
– PhRMA, individual pharmaceutical
sponsors
– ad agencies and associations
– communications groups
– media providers (print, TV, radio, internet)
– Federal Trade Commission (FTC)
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
Stakeholder Perspectives - 3
 DTC
is bad -- should be stopped
– some consumer groups (e.g., Public
Citizen, Center for Medical Consumers,
National Women’s Health Network)
– managed care (AMCP)
– historically, generic manufacturers
– Drug Enforcement Administration (DEA)
Focus of Arguments
 Patient-physician
interaction/relationship
 Prescribing behavior
 Patient knowledge about drugs
 Product costs
Current Situation
 Close
surveillance and quick enforcement
 Encourage compliance -- cooperate with
voluntary requests for pre-review and
comment
 Assessing impact
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
What is DTC’s 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 (?)
FDA’s Research
 Patient/Physician
interaction
– is DTC influencing patient behavior?
- national survey of patients’
behaviors and attitudes
 2000
– www.fda.gov/cder/ddmac/research.htm
Methodology
 National
probability sample
– focus on patients visiting doctor in last 3
months about a problem of their own
 Telephone
interview (n=1,081)
 Final sample
– 960 who had seen doctor in last 3 months
– 121 who had not
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
Self-Reported Health
Poor
Fair
Good
Very Good
Excellent
0
10
Seen MD in last 3 months
20
30
40
Not seen MD in Last 3 Months
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)
Where Was Advertisement
Seen or Heard?
(Multiple responses accepted)
94%
Television
66%
Magazine
29%
Newspaper
28%
Radio
17%
In the Mail
9%
Internet
0
20
40
60
80
100
n = 688
What Information is Recalled
from TV Ads?
87%
Benefits
82%
Risks/Side effects
81%
Who should not take
76%
Who should take
Directions for use
64%
Questions for doctor
63%
10%
Overdosage
0
20
40
60
100
80
n=688
Information Seeking in
Response to an Ad
60
50
51%
41%
40
30
20
Seen MD in Last 3
Months
Not Seen MD in Last 3
Months
10
0
Has an ad for a prescription drug ever caused you to look for more
information, for example, about the drug or about your health?
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%)
How Many Read the Brief
Summary?
3%
15%
30%
11%
14%
It was there?
None
A Little
About Half
Almost All
All
26%
n=688
What if Especially Interested in
the Product?
4%
3%
8%
12%
None
A Little
About Half
Almost All
All
73%
n=688
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%)
DTC Encouraging Discussion?
30
27%
25
20
15
8%
10
Seen MD in Last 3
Months
Not Seen MD in Last 3
Months
5
0
Has an ad ever caused you to ask a doctor about a medical condition or
illness you hadn’t previously talked about?
Awareness Influences Asking
40
35%
35
30
25%
25
20
Asked about a drug
to treat condition
Asked about a
specific brand
16%
15
10
6%
5
0
Seen an Ad
Not Seen an Ad
How Did Doctor React?
81%
Welcomed question
79%
Discussed drug
Reacted like ordinary
part of visit
71%
4%
Angry or upset
0
20
40
60
80
100
Which of these possible reactions did your doctor have when you
asked about the drug?
n = 220
Feelings About Doctor’s
Reaction
2%
5%
Very Unsatisfied
3%
Unsatisfied
48%
37%
Neither Satisfied nor
Unsatisfied
Satisfied
Very Satisfied
n=220
What Did Doctor Do?
Gave Rx asked about
50%
32%
Recommend diff Rx
29%
Behavior/lifestyle chg
15%
Recommend no drug
14%
Recommend OTC
12%
Other
0
10
20
30
Did your doctor do one or more of the following?
40
50
n = 220
Reason(s) Given for Not
Prescribing Drug
 For
59% who didn’t get requested drug
prescribed, the doctor said why (n=65)
–
–
–
–
–
–
–
not right for patient
wanted patient to take different drug
side effects patient didn’t know
patient didn’t have condition
patient didn’t need prescription drug
patient could use OTC drug
less expensive drug available
48%
35%
29%
23%
20%
12%
8%
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
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%
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%
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
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
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?
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