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.

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.

Status Legend:

Review Pending-GAO has not yet assessed implementation status.

Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.

Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.

Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.

• Review Pending
• Open
• Closed - implemented
• Closed - not implemented

Recommendations for Executive Action

Recommendation: 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.

Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

Status: Closed - Implemented

Comments: 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.

Recommendation: 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.

Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

Status: Closed - Not Implemented

Comments: 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.

Recommendation: 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.

Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

Status: Closed - Not Implemented

Comments: 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.