United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2006-11-16 monographic deposited born digital 52 p. GA 1.13:GAO-07-54 https://www.govinfo.gov/app/details/GAOREPORTS-GAO-07-54 P0b002ee180378eae f:d0754 DGPO 2010-08-12 2011-03-23 GAOREPORTS-GAO-07-54 machine generated eng fdlp REPORT GAOREPORTS-GAO-07-54 GAO-07-54 Advertising Consumer protection Cost analysis Pharmaceutical industry Policy evaluation Prescription drugs Regulatory agencies Sales promotion Surveys Evaluation criteria Public health Policies and procedures Other Written Product A63508 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. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-07-54/html/GAOREPORTS-GAO-07-54.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-07-54/pdf/GAOREPORTS-GAO-07-54.pdf GAO-07-54 https://www.govinfo.gov/app/details/GAOREPORTS-GAO-07-54 Other Written Product GAO-07-54; Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising; Advertising Consumer protection Cost analysis Pharmaceutical industry Policy evaluation Prescription drugs Regulatory agencies Sales promotion Surveys Evaluation criteria Public health Policies and procedures