FDA Outlines New Rx Labeling

By Gebhart, Fred | Drug Topics, April 2009 | Go to article overview

FDA Outlines New Rx Labeling


Gebhart, Fred, Drug Topics


The new label has specific requirements for both content and appearance.

Not sure how to use or even read the new label format for prescription drugs? Plenty of other healthcare professionals are having the same problem. As a result, the U.S. Food and Drug Administration (FDA) is explaining the changes at professional association meetings nationwide.

"[The] drugs that the Food and Drug Administration [approves] are getting more complex," Denise Cook, MD, senior reviewer in the Division of Dermatology and Dental Products (DDDP) at FDA's Center for Drug Evaluation and Research, told participants at the American Academy of Diabetes annual meeting held in San Francisco. "That is why drug labeling was getting more complex and harder to use. We had a mandate to make labeling more informative, more accessible, and easier to use."

Authority for a new product label format is part of the Food and Drug Administration Amendments Act of 2007 (FDAAA), said DDDP chief Susan Walker, MD. The new label is the latest step in the evolution of FDA responsibility and authority that began when drug safety requirements were introduced in 1938. FDAAA gave the agency new mandates to improve drug safety, including changes to labeling.

One of the key changes is responsibility for label content. Under the old rules, manufacturers wrote drug labels and FDA approved the content. FDA reviewers could request changes, but drugmakers were under no compulsion to comply. "If changes were necessary, we had to negotiate with manufacturers to get the best wording possible," Walker said. "Now we can require labeling changes to be made, and we can require the form those changes wiD take." One of those required changes is a standard format. The familiar oldstyle package insert contains different subject headings that can appear in a different order on each product. Labeling information is typically printed in small font that can be difficult to read without magnification, Cook said.

The new label has specific requirements for both content and appearance. Text in the main body of the label must be in at least 8-point font with specific layout and white space rules to make reading easier. There are also requirements for the order in which topics appear. New-style package inserts begin with a highlights section, followed by a table of contents and full prescribing information. Topics must be addressed in a specific order within each section. FDA wants to reduce the number of medication errors related to drug information that is misunderstood or incorrectly applied. …

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