Introduction to the New Prescription Drug Labeling by the FDA

Abstract and Introduction

Abstract

Purpose: The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described.
Summary: A new FDA final rule, "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," became effective in June 2006. The rule is part of FDA's initiative to manage the risks of medical product use and minimize adverse events. The new labeling reorders and reorganizes sections found in the previous labeling format. A label is now divided into highlights of prescribing information, contents of the full prescribing information (FPI), and the FPI. The highlights section is a half-page summary of the information that health care practitioners most commonly refer to and view as most important. This section contains cross-references to details in the FPI section. The contents section serves as a navigational tool that references all the sections in the FPI. The FPI section has been revised as to content, format, and order to make information clearer and more usable. FDA has instituted a flexible implementation schedule that phases in the new labeling requirements; more time to achieve compliance is provided for older products. The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA. The new requirements do not apply to nonprescription drug products.
Conclusion: FDA has designed new labeling to help health care practitioners easily find, read, and convey information important for the safe and effective use of prescription drugs.

Introduction

For the first time in over 25 years, the Food and Drug Administration (FDA) has revised the content and format of prescription drug labeling to give health care practitioners prescribing information that is clearer and more concise. Changing several features of the labeling makes it easier to read and draws attention to the most important drug information prior to prescribing. The initiative stems from a new FDA final rule," Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," which became effective on June 30, 2006.^[1,2,3] This final rule is part of FDA's strategic initiative to manage the risks of medical product use and minimize adverse events involving the products it regulates.

A prescription drug product label (also known as a professional label, package insert, direction circular, and package circular) is a compilation of information about a product written by the manufacturer and approved by FDA. Labeling is based on the agency's thorough analysis of the new drug application (NDA) or biological license application. The labeling, or prescribing information, is thus subject to FDA regulations and is a requirement for all approved drug and biological drug products. A label contains information necessary for safe and effective use and is written primarily for the health care practitioner.

FDA recognizes that prescribing information has become very long, detailed, and complex and that specific information is often difficult to locate. Confusing medical information maybe contributing to the approximately 300,000 preventable adverse events occurring each year in U. S. hospitals.^[3] Research has shown that these adverse events may be reduced by prioritizing the warning information on the label.

In redesigning prescription drug labeling, FDA developed prototypes and conducted surveys, convened focus groups, and held public meetings.^[1] Pharmaceutical industry and trade group representatives, health care professional organizations, consumer advocacy organizations, and individual practitioners submitted comments. The participants in this process expressed broad agreement that prescribing information could be more effective and overwhelmingly supported FDA's goal of improving labeling content and format.^[1] FDA identified the most common ways practitioners use prescription drug labeling and the prescribing information they consider most important and applied its findings to the revisions.

Cite this: Introduction to the New Prescription Drug Labeling by the Food and Drug Administration - Medscape - Dec 01, 2007.

Table 1. Implementation Schedule for New Labeling Requirements
Applications Required To Conform to New Requirements^a	Time by Which Conforming Labeling Must Be Submitted to FDA for Approval
Applications submitted on or after June 30, 2006	Time of submission
Applications pending on June 30, 2006, and applications approved 0-1 yr before June 30, 2006	June 30, 2009
Applications approved 1-2 yr before June 30, 2006	June 30, 2010
Applications approved 2-3 yr before June 30, 2006	June 30, 2011
Applications approved 3-4 yr before June 30, 2006	June 30, 2012
Applications approved 4-5 yr before June 30, 2006	June 30, 2013
Applications approved more than 5 yr before June 30, 2006	Voluntarily at any time

^aIncludes new drug applications, biological license applications, and efficacy supplements.

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