Download Merging Marketing and Clinical

Regulatory & Public Health
Implications of DTCA
Economists Conference
Louis A. Morris, Ph.D.
April 29, 2003
AARP Bulletin, March 2002
AARP Bulletin, March 2002
March 13, 2002
March 14, 2002
More Than Ads, Drug Makers
Rely on Sales Representatives
Backlash Rises Against Flashy Ads
For Prescription Pharmaceuticals
Ad Agencies Begin to Participate
FDA Is Inundated Trying
In Development of New Drugs
To Assess Drug Ad Pitches
European Drug Makers May Utilize
More Aggressive Marketing Tactics
FD&C Act - 1962 Amendments
Advertisements and Labeling
must contain a true statement of the drug’s
intended uses
cannot be false or misleading
must contain a brief summary
Regulations
fair balance
contextual
overall
DTC Policy “Change”
Draft Guidance - July, 1997
comment period closed October, 1997
Adequate Provision
toll free telephone
concurrent print or other availability
HCP (MD, RPh, Vet.) provide information
Internet
Presumes Major Statement
FDA Letters: 8 Pitfalls of DTCA
Reminder/Institutional
Implied Claims
Disclosure Adequacy
Contextual Fair Balance
Limits on Effectiveness
Overall Fair Balance
Unsubstantiated Claims
Distractions
“RID the CLOUD”
2002 DDMAC Letters
N = 27
DTC Objections
Medical Meeting
9
5
Oral Statements
Oral Statements at Hosp
Outcomes Claims
Web – Pre-approval
3
1
2
1
Down from over 100 letters in previous years
Seems like the same mix of topics
2002 DTC Ads
Media
TV/Radio
Print
Telephone
5
4
1
FDA Objection
Lack of Risk Info
Misleading Implications
Fact-Claim Discrepancy
Not a Reminder
3
4
3
2
Lots of claim interpretation objections for DTC
March 31, 2003
Ads Boost Consumer Awareness
Of Drugs, but Downplay Risks
.
Drug makers spent almost $3 billion on consumer ads last year, about
a 7% increase over 2001. And consumers generally like them,
notwithstanding some suspicions that the ads inflate drug costs,
surveys show. But doctors, regulators and consumer advocates
continue to have concerns.
A survey of 500 doctors conducted by the FDA last year and presented
at the conference asked whether consumer drug ads confused patients
about the relative risks and benefits of medicines. Some 70% of
general practitioners and 60% of specialists answered "somewhat" or
"a great deal." Only 5% of general practitioners and 10% of specialist
said "not at all."
DTC
April 15, 2002
ADVERTISING
Patients' Success in Drug Requests
Shows the Power of Medication Ads
Beneficial Effects – MD Survey
YES
41%
NO
59%
Did the fact that this patient saw an advertisement have any beneficial effects
for your interaction with this patient?
Aiken, 2003
N = 459
What beneficial effects did it
have?
53%
Better discussion with patient
42%
Patient more aware of treatments
Informs/educates
10%
Patient more likely to take prescribed drug
10%
9%
Patient more likely to consider using Rx drug
6%
New condition was discovered
2%
Patient sought treatment for serious condition
3%
Some other reason
0
10
20
30
40
50
Percent
Aiken, 2003
N = 187
60
Problems
YES
18%
NO
82%
Did the fact that this patient saw an advertisement create any problems
for your interaction with this patient?
Aiken, 2003
N = 459
What problems did it cause?
Time correcting misconceptions
41%
26%
Drug not needed/did not have condition
9%
Wanted Rx rather than other treatment
More visit time
5%
Pressure to prescribe
5%
Should listen to Dr rather than ad
4%
Concerns-insurance
4%
Concerns-SE's
2%
Unrealistic expectations
2%
9%
Some other reason
0
Aiken, 2003
10
20
30
40
Percent
N = 187
50
Current Views of DTC
Surveys show few Benefits, few Problems
Risk Communication – balance a key issue
Suggestion to pay into consumer education “pot”
DTC remains heavily regulated
Implied Claims often focus of objection
FDA regulation is mitigated by GC review
Doctors still skeptical
Still despised by MCOs and payers
Risk Management Issue
Forteo (Lilly), no DTC