FDA Redesigns Prescription Drug Information Format

Good news: The FDA has revised the format for providing prescription drug information to present that information more clearly and concisely.

The package insert, redesigned for the first time in more than 25 years, will provide the most-up-to-date information in an easy-to-read format intended to quickly lead physicians and patients alike to the most important pieces of information. The new format is also designed to make information more accessible for physicians using electronic prescribing tools or electronic health records.

The most prominent change is the introduction of a new "Highlights" section that typically will be a half-page in length and provide a summary of information referenced in specific areas, including "Boxed Warning," "Indications and usage," and "Dosage and "Administration."

A new "Table of Contents" will direct readers to needed information, and a reorganized "Full Prescribing Information" section will highlight the most important and commonly referenced information.

According to the FDA, 300,000 preventable adverse drug events occur in U.S. hospitals each year, many resulting from confusing medical information. It is hoped that prioritizing important information via the redesigned package inserts can reduce these errors.

FDA officials stated they expect the small print that accompanies most print drug ads to disappear as a result of this redesign and that television ads might have to change how they discuss the safety risks of their medication.

Package inserts must be revised by June 30 for new prescription drugs (defined as those that reach the market after May 11) and within seven years for drugs between one and five years old.