The FDA is responsible for overseeing direct-to-consumer (DTC) advertising (ad) of prescription drugs, which includes TV, magazines, and the Internet. If FDA identifies a violation of laws or regAis. in a DTC ad material, the agency may issue a regulatory letter (RL) asking the drug co. to take specific actions. In 2002, there were delays in FDAAis issuance of these RL. This testimony discusses trends in FDAAis oversight of DTC ad and the actions FDA has taken when it identifies violations. This statement discusses the: (1) DTC ad materials FDA reviews; (2) FDAAis process for issuing RL citing DTC ad materials and the number of RL issued; and (3) the effectiveness of FDAAis RL at limiting the dissemination of false or misleading DTC ad. Charts and tables.We found that the number of final DTC materials FDA received each year had almost doubled from 2002 through 2005. Since 2006, the number of materials received by FDA has continued to increase. While FDA officials told us that theanbsp;...
|Title||:||Prescription Drugs: Trends in FDA's Oversight of Direct-to-Consumer Advertising|
|Publisher||:||DIANE Publishing - 2008-10|