GAO-07-54 Published: Nov 16, 2006. Publicly Released: Dec 14, 2006.
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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
| 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. |
Full Report
The concept of a stringent regulatory authority or SRA was developed by the WHO Secretariat and the Global Fund to Fight AIDS, Tuberculosis and Malaria to guide medicine procurement decisions and is now widely recognized by the international regulatory and procurement community. WHO prequalification procedures and several other WHO guidance documents relating to the quality of medicines provide mechanisms to rely on SRAs. However, ICH has undergone structural changes and has expanded its reach to include organizations and associations at the global level. In view of these developments the WHO Secretariat proposed an interim definition of an SRA. The interim definition of an SRA includes the same elements as the current definition, each qualified by the wording “as before 23 October 2015”, as follows:
“A regulatory authority which is:
- a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [ICH], being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency [as before 23 October 2015]; or
- an ICH observer, being the European Free Trade Association, as represented by Swissmedic, and Health Canada [as before 23 October 2015]; or
- a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement, including Australia, Iceland, Liechtenstein and Norway [as before 23 October 2015].”
List of Stringent Regulatory Authorities [SRAs]
WHO Technical Report Series 1003
Based on the above interim definition, the following is the list of the countries whose NRAs are designated as SRAs.
Australia
Austria
Belgium
Bulgaria
Canada
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Japan
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
Switzerland
United Kingdom
United States of America
Norway