E-DRUG: GAO: FDA needs to improve oversight of Direct to Consumer
Advertising
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[The United States Government Accountability Office (GAO, see www.gao.gov)
is the Congress "watchdog" of government. In a new report GAO criticizes the
Food and Drug Administration (FDA) for being too lax in controlling Direct
to Consumer Advertising (DTCA). The USA is one of the few countries that
still allows DTCA. Below the one-page extract; the full report is available
at: http://www.gao.gov/new.items/d0754.pdf Wilbert Bannenberg, E-drug
moderator]
Why GAO Did This Study
The Food and Drug Administration (FDA) is responsible for overseeing
direct-to-consumer (DTC) advertising of prescription drugs. If FDA
identifies a violation of laws or regulations in a DTC advertising material,
the agency may issue a regulatory letter asking the drug company to take
specific actions. GAO was asked to discuss (1) trends in drug company
spending on DTC advertising and other activities; (2) what is known about
the relationship between DTC advertising and drug spending and utilization;
(3) the DTC advertising materials FDA reviews; (4) the number of regulatory
letters that cited DTC materials and FDA's process for issuing those
letters; and (5) the effectiveness of these letters at limiting the
dissemination of violative DTC advertising. GAO reviewed research
literature, analyzed FDA's processes, and examined FDA documentation.
What GAO Found
Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising
Drug company spending on DTC advertising-such as that on television and in
magazines-of prescription drugs increased twice as fast from 1997 through
2005 as spending on promotion to physicians or on research and development.
Over this period, drug companies spent less each year on DTC advertising
($4.2 billion in 2005) than on promotion to physicians ($7.2 billion in
2005) or research and development ($31.4 billion in 2005).
Studies GAO reviewed suggest that DTC advertising has contributed to
increases in drug spending and utilization, for example, by prompting
consumers to request the advertised drugs from their physicians, who are
generally responsive to these requests. Evidence suggests that the effect of
DTC advertising on consumers can be both positive, such as encouraging them
to talk to their doctors, and negative, such as increased use of advertised
drugs when alternatives may be more appropriate.
FDA reviews a small portion of the DTC materials it receives. To identify
materials that have the greatest potential to impact public health, FDA has
informal criteria to prioritize materials for review. However, FDA has not
documented these criteria, does not apply them systematically to all of the
materials it receives, and does not track information on its reviews. As a
result, the agency cannot ensure that it is identifying or reviewing those
materials that it would consider to be the highest priority.
FDA has taken longer to draft and review regulatory letters and the agency
has issued fewer letters per year since 2002, when legal review of all draft
regulatory letters was first required. From 2002 through 2005, from the time
FDA began drafting a regulatory letter for a violative DTC material, it took
the agency an average of 4 months to issue a regulatory letter, compared
with an average of 2 weeks from 1997 through 2001. FDA has issued about half
as many regulatory letters per year since the 2002 policy change.
The effectiveness of FDA's regulatory letters at halting the dissemination
of violative DTC materials has been limited. The 19 regulatory letters FDA
issued in 2004 and 2005 were issued an average of 8 months after the
materials were first disseminated. By the time FDA issued these letters,
companies had already discontinued use of more than half of the violative
materials. When the cited materials were still being disseminated, drug
companies complied with FDA's requests to remove the materials, and
identified and removed other materials with similar claims. FDA's issuance
of regulatory letters did not always prevent drug companies from later
disseminating similar violative materials for the same drugs. These issues
are not new. In 2002, GAO reported that, by delaying the issuance of
regulatory letters, the 2002 policy change had adversely affected FDA's
ability to enforce compliance. At that time, GAO recommended, and FDA
agreed, that letters be issued more quickly. GAO continues to believe this
is necessary in order to limit consumers' exposure to false or misleading
advertising.
What GAO Recommends
GAO recommends that FDA:
(1) document criteria for prioritizing DTC materials for review,
(2) systematically apply its criteria to materials it receives, and
(3) track which materials it reviews.
In its comments on a draft of this report, HHS disagreed with the
recommendations, stating that they would require vastly increased staff. GAO
believes that FDA already has most of the information that would be required
to establish a systematic process for screening DTC materials.
The full report is available at: