Direct to consumer (DTC) prescription drug advertising is
once again becoming highly controversial. For decades DTC advertising was severely restricted due to the belief
that somehow it interfered with the doctor-patient relationship. Once the Food and Drug Administration (FDA) eased its broadcast restrictions
in 1997, however, it rapidly grew to a more than $4.3 billion advertising
category.
More importantly, substantial data suggests that DTC
advertising is providing major health benefits to the public.
* Surveys carried out by the FDA and Prevention Magazine
found that more than 23 million Americans went to their doctors to discuss a
health condition for the first time after seeing a DTC ad.
* The National Medical Association (NMA), the association
representing African- American physicians, stated in a press release
accompanying its survey of attitudes regarding DTC that: “A majority of
respondents believe that DTC ads promote increased communication between
physicians and patients." The NMA further
called on the pharmaceutical industry “to place more ads in traditionally
African-American media outlets…" (Emphasis added)
* The president of the National Consumers League (NCL),
Linda Golodner, in a response to a survey of NCL members noted that: “With DTC
ads, large numbers of consumers are made aware of medical conditions and
treatments that they may otherwise not know exist.” Golodner in addition
pointed out that, “Often [DTC] ads help destigmatize conditions that may have
otherwise gone untreated due to patient embarrassment and limited medical
knowledge.”
* A survey of physicians by the FDA, while somewhat more equivocal in its findings regarding
the value of DTC, still concluded that a majority of doctors believed that DTC
advertising can “play a positive role in their interactions with their
patients.” The FDA survey, for example,
found that 89% of the doctors surveyed believed that DTC advertising made
patients more involved in their health care, and 85% felt their patients were
more likely to use their prescriptions properly because of the ads. In addition, 69% of the doctors felt the ads
encouraged the hard-to-reach patients to come to them, and 78% said they
thought patients sought treatment for potentially serious conditions because of
DTC advertising.
In fact, one of the most serious health problems facing
the United States is that tens of millions of Americans suffer from serious
undiagnosed or untreated health conditions including diabetes, high blood
pressure, high cholesterol, arthritis and serious psychological disorders, that
would respond to existing prescription drug therapies. For example, the Center for Disease Control
has estimated that 6 million Americans suffer from undiagnosed cases of
diabetes alone. This number is dwarfed by the estimated 18 million Americans
with high blood pressure who are unaware they have this silent killer. DTC advertising is an important way to reach
these high- risk groups.
Despite these facts, there is once again a growing chorus
of critics demanding DTC advertising restrictions. These critics argue that the recent problems
with medications such as Vioxx, Celebrex, and Bextra require far more stringent
regulation of DTC advertising by the FDA. They claim that even after a drug receives marketing approval by the
Food and Drug Administration, incipient dangers still may only become apparent
once these products become widely available. The best way to protect against such dangers these critics argue is to
impose an advertising moratorium on new drugs. Even Advertising Age, in a Viewpoint editorial in this week’s edition,
claims that, “A one or two year moratorium on DTC advertising of new drugs is a
good step to take now.”
The FDA in fact recently has placed advertising moratoria
on two new drugs: Symilin, a diabetes medication, and Palladone, an
analgesic. In the first instance, the
FDA moratorium for medical journal and consumer advertising was mandated for
one year; in the latter case, the restrictions were imposed for six months.
Now to place this debate in context, it must be
remembered that prescription drug advertising regulation is more rigorous than
for any other product in the United States. The FDA controls whether a drug product can
be marketed and has enormous power to penalize any false or deceptive
advertising. Consumers cannot obtain
these products without a doctor’s prescription. In addition, the FDA can require so-called “black box” warnings on drug
labels for products that appear particularly dangerous, and it can provide
detailed prescribing recommendations to physicians. Also, the FDA is tightening its post
clearance screening and information gathering procedures, and it has shown a
willingness to ban or severely restrict the sale of products if new information
raising health concerns become available.
So, despite these facts, what are the critics
demanding? Simply, a sweeping
across-the-board ban or restriction on the advertising of new prescription drug
products. These bans or restrictions
would be imposed on products that have passed through the gauntlet of the
rigorous FDA approval process, and that have health benefits, strictly based on
hypothetical fears of non-quantifiable health risks.
Former Federal Trade Commission chairman, Timothy Muris,
rightly expressed his severe skepticism about this approach in a speech at
ANA’s Legal Affairs conference in January. Muris noted that:
Critics are already trying to link the Vioxx problems
with DTC advertising.
Fewer people
would have been at risk from the unknown side effects of a
new drug, they
contend, if there had been less marketing to consumers.
Pressed to the
extreme, this is an argument that says new drugs are fine,
as long as
consumers don’t know about them!
The critics contend that the knowledge consumers need to
obtain about prescription drugs, however, still will be available from
doctors. Unfortunately, this simply
ignores the fact that information about many important prescription medications
only will be easily accessible to those who have the resources and the
inclination to be in frequent contact with their doctors. If past trends are any guide, however,
millions of Americans from minority and lower income categories will fail to
receive key medical information on a timely basis unless and until some
incipient and potentially highly dangerous condition becomes so acute as to
force them to seek medical assistance.
Certain critics have argued that while these facts may be
accurate concerning some prescription drugs, this type of analysis should not
be applied to so-called “life-style” drugs such as Viagra, Cialis and
Levitra. In fact, Congressman Jim Moran
(D-VA) has introduced legislation that would ban these ads on the broadcast
media from six in the morning until ten o’clock at night on so-called decency grounds.
Ad Age argues that: “Consumers still would have access to
deep information on the Internet and to media coverage about cures. Advantage
would go to the best treatments, not those with the biggest ad budgets.” Medical information on the Internet, however,
is generally unregulated for accuracy. Consumers, therefore, would have to fend for themselves without the
protections that the FDA now provides over DTC prescription drug
advertising. Also, it would be the
poorest and least educated consumers, with the most limited access to the
Internet and other sources of health information in our society, which would be
most adversely impacted by bans or restrictions on DTC prescription drug
advertising.
There is an enormous danger that the recent problems with
some prescription drugs will stampede us blindly into speech restrictions that
will severely damage the many benefits that DTC ads have been providing to the
public. There may be a small number of
circumstances where major known risks may militate against allowing a certain
prescription drug product to be immediately advertised. There are strong reasons, however, to believe
that blanket ad bans would be found to be unconstitutional by the courts. As Supreme Court Justice Sandra Day O’Connor
stated in a recent prescription drug advertising case: “If the First Amendment
means anything, it means that regulating speech must be a last – not first –
resort.” This edict should ring
particularly true in the prescription drug area where censoring information
could severely undermine efforts by consumers to protect their own health.
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