ABSTRACT
Introduction ....................................................................................................... 286 Regulation of the Advertising and Promotion of Prescription Drugs ............... 287 Promoting Prescription Drugs-General Policies ............................................ 288
Prior Approval and Preclearance of Promotional Materials ......................... 288 When Is Preclearance Required? ............................................................. 289 The “Fair Balance” Requirement ............................................................ 289
The Brief Summary Requirement for Prescription Drug Advertisements Directed to Physicians .................................................................................. 290 Advertisements Exempt from the Brief Summary Requirement ................. 290 Product Name and Placement ...................................................................... 291 Submission of Promotional Materials to OPDP........................................... 292 Product Claims for Prescription Drugs ........................................................ 292 Unapproved Products and Unapproved Uses for Approved Products .......... 292 Accelerated Approvals-Relationship to Advertising and Promotion ......... 293 Off-Label Promotion .................................................................................... 293
Public Request/Response ........................................................................ 295 Private Request/Response ....................................................................... 295
Comparative and Superiority Claims ........................................................... 295 Pharmacoeconomic Claims .......................................................................... 296 Quality-of-Life Claims ................................................................................. 296 “New” and “Now-Available” Claims ........................................................... 297 Promotion to Health-Care Professionals ...................................................... 297
The Food and Drug Administration (FDA) has been regulating food and drugs since 1906, when Congress enacted the Federal Food and Drugs Act. In 1938, the Federal Food, Drug, and Cosmetic (FD&C) Act was enacted and gave the FDA authority over the safety of drugs and food additives and established the enforcement processes now followed by the FDA.
