Physician Labeling Proposal

The Food and Drug Administration today proposed a new format for prescription drug labeling that will help reduce medical errors, which according to the National Academy of Sciences may be responsible for as many as 98,000 U.S. deaths annually. FDA believes that this new, user- friendly format will reduce errors in drug prescribing.

"Today's proposal is FDA's latest initiative to improve the labeling of the products it regulates," said Dr. Jane E. Henney, FDA Commissioner. "This proposal is particularly valuable because it will make important information available in a clear, consistent, and readable format that is essential to proper prescribing practices."

Prescription drug product labeling, also known as the package insert, represents a primary means of providing critical information about drugs to practitioners. As part of the drug review process, FDA reviews and approves drug product labeling that is initially proposed by manufacturers.

An FDA study showed that practitioners found drug product labeling to be lengthy, complex, and hard to use. The proposed new format would provide user-friendly labeling that would allow practitioners to quickly find the most important information about the product. One major change is inclusion of a new introductory "Highlights" section of bulleted prescribing information. This section would include the information that practitioners most commonly refer to and view as most important, and it would provide the location of further details elsewhere in the labeling.

The proposed new labeling is expected to reduce practitioners' time spent looking for information, decrease the number of preventable medical errors, and improve treatment effectiveness. The information will be easier to find, read and use, and it should also enhance the safe and effective use of prescription drugs and reduce medical errors caused by inadequate communication. Because these labeling revisions represent considerable effort and are most critical for newer and less familiar drugs, the proposal will apply only to relatively new prescription drug products.