New Rx product labels a step in the right direction

January 19, 2006

The AMA applauded the Food and Drug Administration (FDA) for releasing new product label guidelines this week.

"The AMA has long encouraged the FDA to update the prescription drug package insert to make information more useful and user-friendly to physicians," said AMA Trustee Edward L. Langston, MD. "We look forward to reviewing the final rule and the new format of the package insert."

The new labels are intended to emphasize information most useful to physicians and patients while paring down the small-print legal disclaimers. Legal warnings and diagrams of each drug's chemical structure have been replaced with more up-to-date and easy-to-read information, including a box with "highlights" intended to clearly spell out a drug's risks and benefits. The labeling information also will include new changes such as a table of contents.

"We hope that the new prescription drug information format will help physicians better access and communicate important drug information to their patients," said Dr. Langston. "A new highlights section should make it easier for physicians to review the most important drug information as they make prescribing decisions for patients."