FDA Unveils New Package Insert Format

Final rule calls for 6- and 8-point type.

David Vaczek
Senior Editor


Five years after first proposing a new format for the prescription drug package insert (PI), FDA on January 18 issued a final rule (docket number 2000N-1269). The rule represents a “major revision” of the drug labeling and the first overhaul of the PI in more than 25 years.

The rule calls for two different font sizes for different PI uses. For what FDA terms “trade labeling,” a font size of 6 points is required. Trade labeling refers to “labeling on or within the package from which a prescription drug is to be dispensed.” When PIs are used for other purposes, such as accompanying promotional materials, the rule stipulates an 8-point font.

The agency notes that the font-size requirement is balancing the demands of some consumers and health groups with the concerns of manufacturers. The agency says that prescribing information is generally published in 6- or 7-point type, but sometimes runs smaller. Some advocacy groups were calling for 10- or 12-point type.

Expecting a larger-sized insert, drug firms have worked with printers and labelers to test alternatives to accommodate larger formats. They have also investigated options in expanded labels or outserts. Industry had prepared for an 8-point type requirement.

FDA says it determined that using the two different font sizes “best achieves the agency’s objective of ensuring an acceptable base level of readability for prescription drug labels, while at the same time minimizing cost to manufacturers.”

The agency says that the 8-point size in PIs used promotionally will substantially improve readability. “Even though a larger font size may improve readability, the agency believes that an 8-point minimum type size, combined with other graphical elements, is adequate for drug labeling disseminated in settings where it is likely to be referred to by prescribers (e.g., labeling that accompanies promotional material),” it writes. But the agency agrees that there should be an exception for trade labeling, where it says that 6-point type is satisfactory.

The new format includes a highlights section that will provide immediate access to the most important prescription risks and benefits. Other features include a table of contents, the date of initial product approval, and the inclusion of a toll-free number and Internet reporting information “to encourage more widespread reporting of suspected side effects.”

Drug firms have expressed concern that the highlight box feature exposes them to liability if certain information were not to be included. Revising the proposed rule, FDA in the final rule puts a highlights limitation statement at the beginning of the box. “It is important to emphasize to prescribers that the highlight box does not include all the information needed for safe and effective use,” it says.

But the final rule resists proposed revisions to highlighted limitation-statement language. The limitation statement says: “These highlights do not include all the information needed to prescribe (name of drug) safely and effectively.” Also, the highlight box will be limited to no more than one-half page, which the agency believes is adequate for providing the “introductory” information. “Limiting the length of the box is critical to preserving its usefulness,” it said.

“The newly designed package insert will provide the most up to date information in an easy-to-read format that draws physician and patient attention to the most important pieces of drug information before a product is prescribed. The new format will also make prescription information more accessible for use with electronic prescribing tools and other electronic information resources,” the agency said while announcing the rule.

“By improving the package insert to make it more useful for healthcare providers in their day-to-day clinical practice, we are making it easier for them to explain the benefits and risks of medications to their patients,” adds Department of Health and Human Services secretary Mike Leavitt.


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