A solution to the problems created by DTCA must
guarantee that the public is properly protected from
prescription drugs, and make certain that the limited
amount of information presented in the advertisements
results in a benefit to consumers, and does not interfere
with the patient-physician relationship.
DTCA currently leads to an excessive amount of
confusion between patients and physicians.[1]
A solution must reasonably guarantee that
DTC ads benefit consumers by providing them with
helpful, easy to understand, and comprehensive
information. If consumers are given a more
balanced presentation within DTC ads, then their
conversations with their physicians will be more
informed and beneficial. Listed below are four
potential solutions.
Solution
One: Keep the status quo including the requirements of
the 1997 "Draft Guidance for Industry and
FDA."
As stated before,
many believe that the 1997 interpretation was an
improvement from previous standards, and therefore
should not be altered.
Before 1997 reminder ads on television were
used much more frequently because the regulations were
not conducive to more informative product claim ads.
Reminder ads were extremely vague, stating a
drug's name with no additional information. These
advertisements did in fact create confusion between
physicians and patients.
For example, a president of a major drug
company remembers a gynecologist calling him reporting
that his patient had asked if she was a candidate for
Claritin, an allergy medication. The patient had
no idea what Claritin was for, because reminder ads
cannot give that information. She was hopeful that it
could solve her non-allergy related problem.[2]
Ads such as these provided consumers with
little to no helpful information.
The
1997 "Draft Guidance," however, permitted
for product claim advertisements to be broadcast on television.
These ads were able to divulge much more information
to consumers. Proponents of the current DTCA
guidelines claim that the pre-1997 standards led to
confusion on the part of consumers, and that the
current regulations have solved this problem and
allowed for the dissemination of beneficial
information.
Solution
Two: Create a mandatory testing policy for DTCA.
The
AMA and many public health groups, such as Public
Citizen, have endorsed various sets of voluntary
standards for DTCA of prescription drugs. One
such group is Ethicad. Ethicad is a non-profit
organization dedicated to improving DTCA of
prescription drugs. It is the organization's
belief that DTCA of prescription drugs can be
beneficial to consumers, physicians, and
pharmaceutical companies if some adjustments are
made. It recommends a series of tests to
guarantee the well being of the public. Among
these suggestions is the use of consumer and
physician focus groups that can be used to determine
how well a drug's benefits, uses, and side effects are
being both retained and understood.[3]
The
problems that DTCA of prescription drugs present can
largely be solved if the FDA creates a system of
mandatory testing based on these standards. This
could be done without increasing the size and responsibilities
of the FDA. The FDA's role could simply be to
create a set of research and testing criteria that all
prescription drug advertisements must pass. The
drug companies already direct large amounts of their
advertising budgets to research, after all they have
to be reasonably sure that the ads will result in an
increase in sales. This solution would just
force more of their research to be done according to
FDA standards. Insuring that all advertisements
adequately inform, rather than persuade, the public
will help maximize the informational benefit of DTCA.
Solution
Three: Create a more rigid and standard form for DTC
television ads.
The problems with
DTCA have evolved mainly from the dramatic increase in
television ads, which account for 70% of the
promotional money spent by the drug companies on
advertising.[4]
All ads are required by law to present
information about benefits and risks in a balanced
manner. The
"Draft Guidance" of 1997 permitted
advertisers to meet this standard by, “disclosing
the most serious and the most common risks associated
with the drug and giving out a toll-free number and or
Internet site for consumer access."
It did not, however, give any standard for time
requirements or percentages.
In other words, if an ad can present the most
serious and most common side effects in 10 seconds
then it has met the requirement.
It certainly is true that the whole list of a
drug’s side effects and precautions are unable to
fit into a 30 second advertisement.
But requiring advertisers to spend at least as
much time on risks as they do benefits would certainly
come closer to the balanced presentation requirement
in the law.
In order to assure
that consumers are being adequately informed of the
costs and benefits of a drug, the FDA should require
that 50% of an ad is dedicated to risks.
A study done by
the GAO showed that the amount of risk
information in a television ad recalled by a
consumer is directly related to the amount provided.
In other words, the more risk information presented
results in more retained information by the consumer.
If the information within a DTCA is to have an
overall benefit for the consumer, then the FDA must
change its guidelines to help increase the amount of
risk information obtained by the consumer.
Solution Four:
Change federal law to disallow DTCA.
The overall effect of DTCA may be
harmful to the public.
Rather than educating the public, DTC ads too
often persuade the public into asking for
prescription drugs that they may not have otherwise
have requested or been given.
Prescription drugs have very serious risks
associated with them.
The expertise of a physician is needed in
order to evaluate these risks for each individual
patient. DTC
advertisements are designed to sell products with a
series of complicated and technical guidelines, and
they are used to persuade non-professional consumers
who have little knowledge within the medical field.
Appealing to individual emotions to sell
products as technical and complicated as
prescription drugs is dangerous and poses a serious
threat to the well-being of consumers and the
prescription drug process.
For this reason, direct to consumer
advertising of prescription drugs should be made
illegal by an act of Congress. Next