FDA To Announce New Requirement That Drug Makers Submit Digital Labels for Medications

Drug makers will be required to submit all new or changed labels in a digital format, under a new drug label protocol FDA officials are expected to announce on Wednesday, the Wall Street Journal reports. Under the current label system, there is no central source with up-to-date label information, though most drug makers post labels on their Web sites and the information is included on the FDA Web site. In addition, consumers "rarely see the labels and even doctors often find them tough to navigate," the Journal reports. The new protocol, the first stage of FDA's larger effort to update drug labels, also will require drug makers to submit digital versions of all existing labels to the agency within the next year. The National Library of Medicine will compile the digital labels into an online public archive, called Daily Med, and FDA later this year will launch a Web site containing the drug label information, as well as information about medical devices and other products the agency regulates. Acting FDA Commissioner Andrew von Eschenbach said the aim of the new requirement is to provide labels in a "timely, user-friendly format." FDA later this year is expected to announce size and content changes for labels (Wilde Mathews, Wall Street Journal, 11/2).