which on occasion has caused misunderstandings and conflicts with industry. In the absence of specific regulations for prescription drug advertising directed at consumers, the regulations for professionals have been extended to direct- to-consumer (DTC) advertising. Promotional and Certified CME In pharmaceutical regulation, the terms advertising and promotional labeling collectively are referred to as promotion, despite the fact that the FD&C Act does not use such a term. More recently, use of the term promotion has been expanded to distinguish commercially sponsored continuing medical education (CME), or promotional CME, from certified CME produced by professionally approved providers (ACCME) with or without commercial support. The FDA has provided Guidances, and the industry some self-regulation, on the appropriate use of such media. Objectives and General Requirements of Federal Regulation All regulation of prescription drug communications is intended to limit claims to those supported by the drug label or package insert; to discourage the concealment, subordination, or de-emphasis of important side effects and contraindications; and to require the disclosure of such information as a part of the total promotional message. The FD&C Act and its regulations establish basic requirements for prescription drug promotion: • Full disclosure (with Brief Summary exception for advertising) • Fair Balance • Consistency with approved labeling • Other miscellaneous requirements
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