Transcript Davidson

Food and Drug Administration
Hearings on
Direct to Consumer Advertising
November 2, 2005
James H. Davidson
Davidson & Company
of Polsinelli Shalton Welte Suelthaus LLC
Executive Director
The Advertising Coalition
The Advertising Coalition
• American Advertising Federation
• American Association of Advertising Agencies
• Association of National Advertisers
• Grocery Manufacturers of America
• Magazine Publishers of America
• National Association of Broadcasters
• National Broadcasting Company
• National Cable and Telecommunications Association
• National Newspaper Association
• Newspaper Association of America
• Pfizer, Inc.
• Pharmaceutical Research and Manufacturers of America
• DTC Advertising
• Is Protected
• Commercial Speech
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DTC advertising is protected
commercial speech
DTC advertising has motivated millions
of Americans to seek advice from their
doctors
•
•
•
DTC advertising is protected
commercial speech
DTC advertising has motivated millions
of Americans to seek advice from their
doctors
DTC advertising raises awareness
about under diagnosed conditions and
addresses public health disparities
•
•
•
•
DTC advertising is protected
commercial speech
DTC advertising has motivated millions
of Americans to seek advice from their
doctors
DTC advertising raises awareness
about under diagnosed conditions and
addresses public health disparities
Self-Regulation will enhance quality of
DTC
DTC Advertising is protected
commercial speech
•
Justice Blackman: “As to the particular
consumer’s interest in the free flow of
commercial information, that interest may
be as keen, if not keener by far, than his
interest in the day’s most urgent political
debate.”
• Virginia State Board of Pharmacy v. Virginia Citizens Consumer
Council
DTC Advertising is protected
commercial
• Justice
O’Connor: “ . speech
. . if it is
appropriate for the statute to rely on
doctors to refrain from prescribing
compounded drugs to patients who do
not need them, it is not clear why it would
not also be appropriate to rely on doctors
to refrain from prescribing compounded
drugs to patients who do not need them
in a world where advertising was
permitted.”
DTC advertising has motivated
millions of Americans to seek
advice from their doctors
•
•
62 million Americans say they have
spoken to their doctors about an
advertised medicine
Between 25 and 30 million Americans
have been prompted by an ad to talk to
their physician for the first time about a
medical condition
Are too many
Americans making
appointments with their
doctors?
Advertising should inform and
motivate - but it need not be
encyclopedic
“Less is more”
FDA Commissioner Mark McClellan
Many prompted by ads to
seek help suffer from high
priority conditions
•
Harvard, Massachusetts General Hospital
and Harris Interactive:
• 35 percent of 3,000 patients sought medical
advice after seeing an advertisement
• 25 percent of those received a new diagnosis
• 43 percent of those were for high priority
conditions
DTC Advertising Can Highlight
Under Diagnosed and Under
Treated Conditions
• The Silent Killer
• 30% or 19.5 million don’t know
• 11% are not receiving therapy
• 25% are receiving inadequate therapy
• One out of three adults, or 65 million
Americans, has high blood pressure
DTC Advertising Can Highlight
Under Diagnosed and Under
Treated Conditions
• Diabetes
• 6th leading cause of death in the U.S.
• 21 million Americans affected – 7% of
the population
• 6 million of them don’t know they have
diabetes
DTC Advertising Can Highlight
Under Diagnosed and Under
Treated Conditions
• Depression
• Nearly 40 million Americans suffer from
a depressive disorder
• Only 4 to 8 million Americans are in
active treatment
DTC Advertising Can Highlight
Under Diagnosed and Under
Treated Conditions
• From 1987 to 1997, the percent of
Americans treated for depression tripled
from .7% to 2.3%
• Dr. Mark Olafson: increased number of
“multi-million dollar marketing
campaigns.”
DTC Advertising Can Highlight
Under Diagnosed and Under
Treated Conditions
• Osteoporosis and Bone Health
• ‘The private sector’s financial resources and
ability to reach a huge market can be brought
to bear on the public health issue of bone
health’
• Dr. Richard Kravitz: ‘DTC apparently works . .
. several studies show that DTC ads are read
and acted upon.’
Access to Information by Under
Served Communities
• ‘Access to information is a critical piece
in the access picture for Hispanic and
other under served communities.’
• ‘New research is showing that health
care disparities among black, Hispanic,
and white Americans cannot be
explained wholly by disparities in income
and health insurance coverage among
these groups . . . other factors such as
lack of information play a critical role.’
•
Dr. Jane Delgado, President and CEO of the National Alliance for Hispanic
National Medical Association
• 90 percent of the African American
physicians surveyed said that they had
been asked their medical opinion
because their patients had seen
prescription drug ads.
• Commonwealth Fund: study shows that
minorities lag behind in health care
quality and are more likely to have
communication problems with their
Woman’s Day
• Reaches 20 million – or 1 in 5 –
American women
• Over 100,000 reader panel
Woman’s Day
•Mental Health
•
‘Advertisements for [product] prompted me to visit
my physician to seek relief for my migraine
headaches. I now take [product] and feel like I have
been given my life back. I can live again instead of
worrying about getting a migraine.’
•
Debbie P., Age 51, Painesdale, MIchigan
Woman’s Day
•Mental Health
•
‘I suffered from severe depression and anxiety. I
was trying to find something to even out my moods.
I discussed many medications with my doctor. I had
found an ad for [product] and spoke to him about it.
It turned out to do miracles for mine and my
children's well being as it continued to improve my
quality of life.’
• Samantha J., Age 32, Bedford, Texas
Woman’s Day
•Mental Health
•
‘My mother was very depressed and after months
of being on a prescription, she was not feeling any
better. I read about [product] and talked to her
about getting her prescription changed. She talked
to her doctor, got the new product, and we saw a
change immediately.’
•
Cindy W., Age 49, Muncy, Pennsylvania
Woman’s Day
•Osteoporosis
•
‘As I was waiting for the results of my
second bone density test, I remembered
seeing an ad for [product] which allowed me
to review the medication. Upon meeting with
my doctor it was his suggested medication,
and the ad enabled me to ask questions at
my appointment.’
•
Cindy, H., Age 55, Geneva, New York
Industry Self Regulation Promises
to Enhance Pharmaceutical
Advertising
• PhRMA
• Program of self regulation for prescription drug
advertising
• Committed to delivering messages that educate
patients and consumers and encourage them to
seek guidance from their health care professionals
Conclusion
• How many of the 25 percent of new
diagnoses identified in the HarvardHarris survey would have never occurred
without the prompting of an ad?
• I hope we never have to weigh that risk.