FDA Redesigns PI Format to Improve Safety

ROCKVILLE, Maryland—A new format for use in writing package inserts (PIs) seeks to make prescribing and safety information clearer and more concise for health care professionals and patients. The design will apply to all future drugs FDA approves. All drugs approved within the past 5 years will be converted gradually to the new format. The agency said the new design for package inserts is an effort to better manage the risks of medication use and reduce medical errors.

The new design includes an opening Highlights section that provides a brief summary of such important topics as black-box warnings, indications, and usage. The drug sponsor must also include in Highlights all the substantive insert changes for the drug made within the last year. A new table of contents gives readers an easier way to find safety, efficacy, and other data. Several sections previously buried deep in the document, such as dosage, will be given more prominent display at the beginning of the Full Prescribing Information section.

New Patient Counseling Info

A new Patient Counseling Information section is designed to help doctors advise patients about the uses and important limitations of each product, and serve as a guide for discussions about potential risks of the medication and how to manage them. If FDA has approved a patient information sheet for a drug, it will appear immediately after the patient counseling material or will accompany the label so it can be handed to a patient.

In addition, companies must provide the date the product received its initial FDA approval, a requirement intended to allow readers to more easily determine how long it has been on the market. And the new format will also include a toll-free number and an Internet address for reporting suspected adverse events.