E-drug: Poor DTC ad enforcement
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Testimony of Sidney M. Wolfe, MD
Director, Public Citizen's Health Research Group
Senate Commerce Committee
Subcommittee on Consumer Affairs
Hearing on Direct-to-Consumer (DTC) Advertising
July 24, 2001
Because of the strong First Amendment in the U.S constitution,
there is no way that DTC prescription drug advertising could ever
be banned in this country. Having said that, however, there is an
urgent need for more fine-tuned, better-staffed and much tougher
government regulation of its content. There is little doubt that false
and misleading advertising to patients and physicians can result in
prescriptions being written for drugs that are more dangerous
and/or less effective than perceived by either the doctor or the
patient. This can then lead to a subsequent toll of deaths and
injuries that would not have occurred had safer, more effective
drugs been prescribed.
The more than 500 prescription drug advertisements that have been
found by the FDA to violate federal laws and regulations from 1997
through the present include approximately 90 DTC ads. These
numbers would be significantly larger if FDA�s DDMAC (Division of
Drug Marketing Advertising and Communication) had more staff to
investigate the rapidly expanding area of DTC drug promotion. Such
advertising has more than tripled in dollar volume from $791 million
in 1996 to $2.5 billion in 2000. But the number of FDA staff
assigned to reviewing and investigating all of prescription drug
advertising, during the same interval, has only increased from 11 in
1996 to 14 at present. I have been informed that there is, or will
shortly be, an increase in DDMAC staff to monitor such advertising
and it comes none too soon. Even this may well not be adequate.
There has been a sharp and steady decrease during the last three
years in the number of FDA warning letters and notices of violation
of FDA laws and regulations to drug companies concerning
prescription drug advertising. From a peak of 84 such enforcement
actions during the first six months of 1998, the number has fallen
steadily to 36 FDA actions during the last six months of 2000 and
an estimated 38 actions during the first six months of 2001.
For the last year (mid-2000 through mid-2001) the total number of
DDMAC advertising enforcement actions�74�was less than
one-half (47%) of the 158 enforcement actions taken three years
ago (mid-1997 through mid-1998). There is no evidence of an
advertising/pharmaceutical industry epiphany, resulting in fewer
illegal advertisements for prescription drugs. Therefore, the only
plausible explanation for this dangerous decrease is that the police
force---DDMAC--- has not been strong enough in numbers of
investigators along with a lack of adequate pro-enforcement
leadership from the top officials in FDA. That this latter explanation,
inadequate enforcement, is correct will be seen when the FDA, with
the urging and support of your committee, begins to increase the
number of actions taken against these violative ads. Until then,
Americans---both physicians and patients---will be harmed by
prescribing decisions about which drugs to use based on
all-too-frequently false and misleading information from
advertisements which are much less likely to be stopped because of
poorer enforcement by the FDA.
In addition to more staff, there is a dire need for DTC-specific
regulations since, other than the late 1990�s guidance concerning
TV advertising---which is a guidance not a regulation---there are no
regulations specifically written for DTC advertising. The FDA has
been using the regulations promulgated after the 1962
Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act
that were clearly intended for prescription drug advertising directed
at health professionals such as doctors and pharmacists. We have
been urging the agency since the mid-1980s to propose and finalize
such consumer specific DTC regulations that would make it easier
to evaluate the ads in the context of patient, not health
professional, comprehension. Beyond more staff and DTC-specific
regulations there is a need for much more enforcement power. At
present, the FDA is limited to a Notice of Violation or Warning
Letter to companies found to violate the law or regulations.
Theoretically, in the face of multiple warnings to the same
company, criminal prosecution is a possible tool. This latter power
has only been used a handful of times in the past 35 years. To our
knowledge, criminal prosecution has never been used in the context
of DTC advertising, despite, for example, a series of 11 illegal ads
for Claritin (8 DTC), 14 illegal ads for Flonase/Flovent (8 DTC).
(Flonase and Flovent are the same drug in two versions, one used
for allergy, the other for asthma). There have also been five illegal
ads for Celebrex (1 DTC).
The ability to assess drug companies large civil monetary penalties
for advertising violations might actually serve as a deterrent for
companies who now just stop the violative ad, when requested by
the FDA, then create and massively disseminate a new one shortly
thereafter. The FDA currently lacks the authority to impose any civil
penalties for drug advertising or, in fact, for any other illegal drug
industry activity concerning prescription drugs. It is long overdue
that the Congress give the FDA this authority.
A search of the peer-reviewed, published medical studies
concerning DTC advertising yields findings that, for the most part,
are also quite worrisome:
- In one study, researchers found that consumers rated the safety
and appeal of drugs described with an incomplete risk statement
significantly more positively than those whose risks were
described more completely.[1] (This has significant implications
since so many DTC ads understate the safety of drugs.)
- Another study found that consumer beliefs that there was prior
scrutiny of DTC ads by the FDA and that they were held to
higher standards than other ads were generally wrong. A
substantial proportion believed that only the safest and most
effective drugs could be advertised DTC and that the FDA
required prior review of ads. DTC ads led one-fifth of people to
request a prescription.[2]
- A study on the educational content of DTC ads found that while
many ads provided information about the name and symptoms of
the disease for which the drug was being promoted, few
educated the patients about the success rate of the drug, how
long you had to use the drug, alternative treatments including
behavioral changes which could improve their health, or
misconceptions about the disease. The authors concluded that
the ads provided only a minimal amount of educational
information.[3]
- One study asked patients what they would do if a doctor refused
to prescribe a drug that the patient wanted as a result of a DTC
ad. One-fourth of patients said they would seek a prescription
elsewhere and 15% said they would consider terminating their
relationship with their physician. The patients with these
attitudes were ones who had a more favorable evaluation of DTC
advertising and who possessed more faith in the current
government regulation of DTC drug ads.[4]
In summary, FDA resources and specific regulatory authority to
monitor the accuracy of drug safety and effectiveness portrayed in
DTC ads are dangerously inadequate and many patients�
perceptions of the ads and their subsequent response to the
�information� therein is similarly dangerous. The present situation
concerning DTC advertising is unacceptable and it is our hope that
your committee will initiate actions to remedy these serious
problems.
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[1] J Health Communic 2000 Oct-Dec;5:349-69.
[2] J Gen Int Med 1999;14:651-7.
[3] J Fam Pract 2000;49:1092-8.
[4] J Fam Pract 1999;48:446-52.
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