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Diane Publishing Books
Prescription Drugs: Improvements Needed in FDA’s Oversight of Direct-to-Consumer Advertising
Marcia Crosse (au)
The 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 co. to take specific actions. This report discusses: (1) trends in drug co. spending on DTC advertising & other activities; (2) what is known about the relationship between DTC advertising & drug spending & utilization; (3) the DTC advertising materials FDA reviews; (4) the number of regulatory letters that cited DTC materials & FDA’s process for issuing those letters; & (5) the effectiveness of these letters at limiting the dissemination of violative DTC advertising. The author reviewed research lit. & analyzed FDA’s processes.
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