|
P E R S P E C T I V E
D T C A D V E R T I S I N G
W E B E X C L U S I V E
28 April 2004
Turning Point Or Tipping Point:
New FDA Draft Guidances And
The Future Of DTC Advertising
How to harness the power of direct-to-consumer
advertising
to create better-informed consumers and better potential customers.
By Peter J. Pitts
ABSTRACT:
According to Food and Drug Administration (FDA) research, direct-to-consumer
(DTC) drug ads are not as empowering as they were even three years ago. How
will the FDA’s new draft guidances reverse this trend and affect the future
of DTC advertising? Will they be a turning point, resulting in pharmaceutical
companies’ embracing an educational public health imperative, or a tipping
point with politicians and the public zeroing in on aggressively targeted DTC
ads as the postimportation pharmaceutical bête noire? The FDA believes
that its new guidances strengthen the strategic argument that a better-informed
consumer lays the groundwork for a better potential customer.
One of the Food and Drug Administration’s (FDA’s) five strategic goals
is to help create better-informed consumers. And that means better-educated
consumers, empowered to choose and use medical products to improve their own
health. Direct-to-consumer advertising (DTCA) is an important arrow in that
quiver.
Promoting positive change.
It is not an understatement to say that when it comes to DTCA, we’ve come
a long way. The genie is out of the bottle. In September 2003 the FDA held a
two-day public meeting on the subject.1 According
to research presented by academics from such places as Harvard Medical School
and the Mayo Clinic and from consumer advocates such as the National Consumers
League, DTCA is advancing America’s health—most specifically, by getting
people to visit their doctors.2
That shouldn’t be a surprise to anyone who’s taken Marketing 101,
because advertising legitimizes. More specifically, DTCA helps to destigmatize
certain diseases and encourages people to talk with their doctors about problems
previously considered taboo, such as depression. Other research demonstrated
little or no correlation between a brand’s DTCA spending and its cost.3
In other words, brands that spend more heavily on DTCA do not necessarily cost
more than their less heavily advertised competition.
According to an FDA study conducted in 2002, of patients who visited their doctors
because of an ad they saw and who asked about that prescription drug by brand
name, 88 percent actually had the condition treated by the drug.4
But has the public health been served? The answer is a qualified “yes.”
According to the same FDA study, slightly less than half of doctors said that
DTCA-generated visits resulted in better discussions and made the patient more
aware of treatments. And in 6 percent of those visits, a previously undiagnosed
condition was discovered. Why is this so important? Because earlier detection
combined with appropriate treatment means that more people will live longer,
healthier, more productive lives without having to confront riskier, more costly
medical interventions later on.
Only 7 percent of doctors said that they felt “very pressured” to
prescribe a particular advertised drug. When the FDA panel probed what was meant
by “pressure to prescribe,” we found that the real pressure was time
pressure. More patients are coming to see the doctor, armed with more questions.
Do physicians feel that DTCA advances the public health? It depends. According
to our study, a majority of doctors believe that DTCA increases patients’
awareness and involvement, improves their compliance, and improves the overall
doctor-patient relationship. But only 40 percent said that DTCA has affected
their patients and their practice either “very” or “somewhat”
positively. Another 32 percent believed that DTCA has a “somewhat”
or “very” negative impact; the remaining 28 percent said that it has
no impact at all. Is there room for improvement? Absolutely.
Deterring negative effects.
The FDA’s job is not only to encourage good ads, but also to deter false
or misleading ones. It is a threat to the public health when people make important
health care decisions based on false or misleading facts. The FDA is working
to decrease the incentives to push the limits of the law by increasing the cost
of doing business the wrong way. Warning Letters are a concrete example. Today
the FDA uses them to presage enforcement action, not to substitute for it.
How can the FDA work with our various stakeholders to make DTCA better? Let’s
investigate the problem so we can find the solution. According to the FDA’s
2002 study, 65 percent of doctors believed that the DTC ads their patients saw
confused them about the relative risks and benefits of prescription drugs—and
that is a problem. In a 1999 FDA study, 56 percent of patients who saw a DTC
print ad said that they read the brief summary “not at all” or “a
little.”5 In the 2002 study that number jumped
to 73 percent—an increase of seventeen percentage points. During that same
three-year span, those saying they read “almost all” or “all”
fell from 26 percent to 16 percent— these ten percentage points are not
decimal dust by any stretch of the imagination.
In the “decimal dust” category, consider this: In 1999, 3 percent
said that they weren’t aware that the brief summary even existed. In 2002
that dropped a full decimal place to 0.3 percent. In other words, more people
knew that the brief summary was there, but fewer people were reading it. That
reflects how people’s attitudes toward DTCA changed during those three
years—for the worse. In 1999, 70 percent of patients surveyed agreed either
“strongly” or “somewhat” with the statement, “Advertisements
for prescription drugs give enough information for me to decide whether I should
discuss the drug with my doctor.” In 2002 that number fell to 58 percent—not
a trivial drop.
If information is power (and it is), then DTC ads are not as empowering as they
were even three years ago. Why is that? The answer is embarrassingly obvious.
Risk information is hidden in plain view, and benefits are communicated broadly.
It’s not a question of fault. It’s a question of fact. Risk information
is neither designed nor delivered to be user-friendly. At present it is designed
to be “in compliance.” We hope that our draft guidance on new ways
to present the brief summary will help change that, because “in compliance”
and “user-friendly” should not be mutually exclusive.6
In his announcement of our new draft guidances on DTCA, then FDA commissioner
Mark McClellan said that when it comes to the brief summary, less may indeed
be more. More of something you don’t understand is counterproductive, counterintuitive,
and counter to the FDA’s strategic goal of producing better-informed consumers.
Recently, Knight-Ridder newspapers asked three experts—a health care consultant,
a linguist, and an optometrist—to review the brief summaries of several
current print ads. Each found the material unreadable.7
Audrey Riffenburgh, a health care consultant, applied a standard readability
formula to one brief summary. On a scale of 1 to 18, with 18 being the most
difficult to read, the brief summary scored a 17. That translates into graduate
school–level reading. Roger Shuy, a retired linguistics professor at Georgetown,
reviewed another brief summary. According to Shuy, “If laypersons are expected
to read this and understand what they are reading, the writer lives in some
other world.” Gary Good, an optometry professor at Ohio State, reviewed
the same brief summary. The print is so small and compressed, he concluded,
that reading it “would be a challenge that many people would not be willing
to undertake.” The FDA’s new draft guidance is designed to help pharmaceutical
companies design brief summaries that are potent public health tools rather
than Mensa tests or eye exams.
As mentioned above, one of the FDA’s five strategic goals is to help create
better-informed consumers. From a business perspective, the strategic argument
can be made that a better-informed consumer lays the groundwork for a better
potential customer. Consider “help-seeking” ads, both print and electronic,
which discuss a disease but don’t mention a product. Our new draft guidance
on such advertising is designed to encourage more of it. We feel that such ads
provide a real public health benefit.
Where will these new guidances take us? Will they be a turning point, resulting
in pharmaceutical companies’ embracing an educational public health imperative
and allotting more media dollars for help-seeking advertising? Or will they
be a tipping point, with politicians and the public zeroing in on aggressively
targeted DTCA as the postimportation pharmaceutical bête noire?
Here’s the same question framed more plainly: When it comes to DTCA, is
long-term thinking in short supply? Is it in DTCA’s long-term interest
for lifestyle drugs to be the “poster children” for DTCA? When that
happens, and considering the white-hot public debate about drug pricing, you
have to wonder about who is thinking long term—and what “long term”
means.
Working together with industry, we can make a difference. We can make DTCA a
more potent, precise, and persuasive tool on behalf of the public health. And
rather than rubbing the lamp and wishing, we need to burn the midnight oil and
work harder to make it a reality—because “an educated consumer is
our best customer.”
NOTES
1. The agenda, transcripts, and presentations from this meeting
are available at www.fda.gov/cder/ddmac/DTCmeeting2003.html
(13 April 2004).
2. S. Allison-Ottey, “DTC and the AA Physician and Patient,”
Presentation at FDA public meeting on direct-to-consumer promotion, Washington,
D.C., 22–23 September 2003,
www.fda.gov/cder/
ddmac/P1AllisonOttey/index.htm (13 April 2004); and J.S. Weissman, “Consumer
and Physician Reports on the Health Effects of DTCA,” Presentation at FDA
public meeting, Washington, D.C., 22–23 September 2003, www.fda.gov/cder/ddmac/P1weissman/index.htm
(13 April 2004).
3. N. Masia, “Economic Impact of DTC Advertising,”
Presentation at FDA public meeting, Washington, D.C., 22–23 September 2003,
www.fda.gov/cder/ddmac/p4masia/index.htm
(13 April 2004).
4. K.J. Aikin, “The Impact of Direct-to-Consumer Prescription
Drug Advertising on the Physician-Patient Relationship,” Presentation at
FDA public meeting, Washington, D.C., 22–23 September 2003, www.fda.gov/cder/ddmac/aikin/index.htm
(13 April 2004).
5. Ibid.
6. U.S. Food and Drug Administration, “New FDA Draft Guidances
Aim to Improve Health Information (P04-12),” 4 February 2004, www.fda.gov/bbs/topics/NEWS/2004/NEW01016.html
(17 March 2004).
7. T. Pugh, “Print Ads for Prescription Drugs Need to Be
Simplified, FDA Says,” Knight-Ridder, 28 January 2004.
Read related papers by Joel
Weissman et al., Steven
Woloshin et al., Pat
Kelly, David
Riggs et al., James
Jeffords, and Henry
Waxman.
Peter Pitts (peterpitts{at}fda.gov) is
associate commissioner of the U.S. Food and Drug Administration in Rockville,
Maryland.
DOI: 10.1377/hlthaff.W4.259
©2004 Project HOPE–The People-to-People Health Foundation, Inc.
|
