Yesterday, The Food and Drug Administration 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.
"This 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
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