FDA designs reader-friendly package inserts

January 29, 2006

Prescription information for new and recently approved products will meet specific graphic requirements and critical information will be reorganized so that physicians can find the information quickly.

Prescription information for new and recently approved products will meet specific graphic requirements and critical information will be reorganized so that physicians can find the information quickly.

Changes include:

•  Highlights, a concise summary of information about specific areas including Boxed Warning, Indications and Usage, and Dosage and Administration.

•  Table of Contents, referring readers to detailed information located in the label.

•  Patient Counseling Information section, helping doctors advise patients about the potential risks involved in a specific treatment and steps for managing those risks.

•  Date of initial product approval to determine how long the product has been on the market.

•  Toll-free number and Internet reporting information to encourage more widespread reporting of suspected adverse events.

"This redesigned label is a big step in our commitment to giving health professionals the tools and information they need to optimize their clinical practice and choose among the growing number of effective treatments to make more personalized prescribing decisions for their patients," said FDA Acting Commissioner of Food and Drugs Andrew von Eschenbach, MD. "This revised prescription information format, in combination with new requirements for electronic labels [announced last month] and requirements for barcodes on drugs, will dramatically improve the way health-care professionals and consumers obtain information about prescription drugs."