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Highlights

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.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration To improve FDA's processes for identifying and reviewing final and draft DTC advertising materials, the Acting Commissioner of the Food and Drug Administration should document criteria for prioritizing materials that it receives for review.
Closed - Implemented
No follow up information was provided by agency in November 2007. No follow up information was provided by agency in July 2009. Here is the text of FDA's Sept. 2011 follow up: FDA implemented this recommendation. FDA, like other regulatory agencies, exercises enforcement discretion to focus resources on enforcement actions that will have the greatest impact on public health. The Division of Drug Marketing Advertising and Communications (DDMAC) has identified criteria that it systematically applies to identify workload priorities for review of both draft and final direct-to-consumer materials that have the greatest impact on public health. These criteria are listed below: promotions that contain egregious violations, labeling review and risk information updates, first TV ad for a product or indication and Subpart H launches, initial core pieces, non-Subpart H launches, initial core pieces, other TV ads and other Subpart H launches and non launches, other launches and advisories The DDMAC management team, and in particular the DTC group leaders, work with all DTC reviewers to ensure that these criteria are consistently applied. DDMAC continually reevaluates workload in light of these priorities, contingent on emerging scientific and regulatory events.
Food and Drug Administration To improve FDA's processes for identifying and reviewing final and draft DTC advertising materials, the Acting Commissioner of the Food and Drug Administration should systematically apply its documented criteria to all of the materials it receives.
Closed - Not Implemented
No follow up information was provided by agency in November 2007. No follow up information was provided by agency in July 2009. Text of Sept. 2011 FDA follow up: As stated above, FDA believes its approach identified above makes the best use of FDA resources and assures review of the most important DTC promotional materials. We do not anticipate that we will be able to implement the GAO recommendation for all the DTC material we receive. In 2010, FDA received 15,930 DTC submissions.
Food and Drug Administration To improve FDA's processes for identifying and reviewing final and draft DTC advertising materials, the Acting Commissioner of the Food and Drug Administration should track which materials have been reviewed.
Closed - Not Implemented
No follow up information was provided by agency in November 2007. No follow up information was provided by agency in July 2009. Text of Sept. 2011 FDA follow-up: FDA has partially implemented this recommendation. Although it would require a state-of-the-art tracking system to track the review of all DTC advertising materials, FDA has put into place the tracking of certain high priority reviews. FDA tracks the review of draft DTC television advertisements and the review of draft core launch materials (i.e., the draft introductory materials for newly approved products or indications containing the key promotional messages and the initial presentation of risk information for the product or indication). FDA does not anticipate being able to take additional steps to implement this recommendation.

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