FDA Announces Digital Prescription Drug Label Requirement
As expected, FDA officials on Wednesday announced that the agency will require pharmaceutical companies to submit new or revised prescription drug labels in a digital format, Reuters reports (Reuters, 11/2). Under the current system, no central source for revised prescription drug label information exists, although most pharmaceutical companies post labels on their Web sites and the information appears on the FDA Web site (Wilde Mathews, Wall Street Journal, 11/2).
According to FDA officials, under the new system, revisions to prescription drug labels will appear on the Daily Med Web site operated by the National Library of Medicine within one business day of approval (USA Today, 11/3).
FDA expects to have labels for most of the estimated 9,000 available prescription drugs posted on the Daily Med Web site within one year (Reuters, 11/2). Prescription drug labels, which in most cases are pamphlets printed in small type that are packaged with medications, include information on the benefits, risks and chemistry of treatments (USA Today, 11/3).
In addition, prescription drug labels in some cases include safety warnings against use in certain individuals or under certain conditions. According to FDA spokesperson Kristen Neese, the agency later plans to require digital labels for vaccines, medical devices, veterinary medications and some food products (Reuters, 11/2).
APM's "Marketplace" on Wednesday reported on the new prescription drug label requirement. The segment includes comments from Edward Langston, a member of the American Medical Association Board of Trustees, and Arthur Levin, director of the Center for Medical Consumers (Palmer, "Marketplace," APM, 11/2). The complete segment is available online in RealPlayer.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.