Editor’s Notes:

The FDA has effected what may turn out to be one of its most important safety innovations in decades: labeling changes that make it easier for doctors and patients to read and understand the clinical benefits (and risks) of FDA-approved medicines. The new labeling format replaces an arcane system that was burdened with complicated jargon and buried critical information in pages of minutiae.

For the first time in more than 25 years, the Food and Drug Administration is revamping the format of prescription-drug labels, a move designed to make it easier for physicians and consumers to get clear information about medications. Drug labels -- sometimes called the package inserts -- are notoriously complicated documents, printed in tiny script that can stretch on for dozens of pages. Written primarily for doctors, they contain FDA-approved information on dosage and side effects. But patients and doctors alike have complained that the inserts are confusing, and there is evidence that physicians don't always follow the labels' recommendations. The new label rule, which has been in the works for several years, reorganizes the inserts into a more easy-to-follow, standardized format. The plan also includes a government database that will ultimately allow people to search for the information online at dailymed.nlm.nih.gov. …

The biggest change to the labels will be a new summary at the beginning called "Highlights." Like the nutrition box that appears on food packages, the new highlights section is designed to telegraph the most important information at a glance, using a standardized format. It will summarize the major uses and side effects of the drug, as well as dosing.

The labeling change has taken years to implement, but is an important signal that the agency is serious about making drug information more consumer friendly. Much remains to be done to empower consumers and physicians to make better treatment choices, but Acting Commissioner Von Eschenbach should be commended for this initiative.