
The FDA has unveiled a major revision to its prescription druginformation format, commonly called the package insert. The changesinclude the following: Highlights, a section that will provideimmediate access to the most important prescribing informationabout benefits and risks; Table of Contents, for easy reference todetailed safety and efficacy information; the date of initialproduct approval; and a toll-free number and Internet reportinginformation for suspected adverse events. Commenting on the plan,Consumers Union said the proposal will make existing drug safetyand risk information clearer to physicians, but the new plan fallsshort of dramatically improving drug safety for consumers becauseit does not require better safety measures from drugmakers.