FDA Unveils New Prescription Drug Information Format

In an effort to manage the risks of medication use and reduce medical errors, the US Food and Drug Administration (Rockville, MD, www.fda.gov) has revised the prescription drug information format, commonly known as the package insert. The new label design is the first revision in 25 years.

The format will require that the prescription information for new and recently approved products meet specific graphical requirements and includes the reorganization of critical information. Significant changes include:

• a “highlights” section that summarizes the most important prescribing information about benefits and risks;

• a table of contents that facilitates reference to detailed safety and efficacy information;

• the date of initial product approval, which makes it easier to determine how long a product has been on the market;

• a toll-free number and Internet reporting instructions to encourage more widespread reporting of suspected side effects.

The agency is encouraging pharmaceutical manufacturers to consider complying with the new labeling requirements on a voluntary basis at first. All drugs approved within the past five years are included and will be converted gradually to the new format.