GAO Report: Prescription Drugs - Trends in FDA’s Oversight of Direct-to-Consumer Advertising
What GAO Found
WASHINGTON, May 8, 2008-Since 1999, FDA has
received a steadily increasing number of advertising materials
directed to consumers. In 2006, GAO found that FDA reviewed a small
portion of the DTC materials it received, and the agency could not
ensure that it was identifying for review the materials it
considered to be highest priority.
While FDA officials told GAO that the agency prioritized the review
of materials that had the greatest potential to negatively affect
public health, the agency had not documented criteria to make this
prioritization. GAO recommended that FDA document and
systematically apply criteria for prioritizing its reviews of DTC
advertising materials. In May 2008, FDA indicated that it had
documented criteria to prioritize reviews. However, FDA still does
not systematically apply its criteria to all of the DTC materials
it receives. Furthermore, GAO noted in its 2006 report that FDA
could not determine whether a particular material had been
reviewed. GAO recommended in that report that the agency track
which DTC materials had been reviewed. FDA officials indicated to
GAO in May 2008 that the agency still did not track this
information. As a result, the agency cannot ensure that it is
identifying and reviewing the highest-priority materials.
GAO found in 2006 that, since a 2002 policy change requiring legal review of all draft regulatory letters, FDA’s process for drafting and issuing letters was taking longer and the agency was issuing fewer letters per year. FDA officials told GAO that the policy change contributed to the lengthened review.
In 2006, GAO found that the effectiveness of FDA’s regulatory letters at halting the dissemination of violative DTC materials had been limited. By the time the agency issued regulatory letters, drug companies had already discontinued use of more than half of the violative advertising materials identified in each letter. In addition, FDA’s issuance of regulatory letters had not always prevented drug companies from later disseminating similar violative materials for the same drugs.
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