 |
FDA Announces the Final Rule on
the Requirements
for Prescribing Information for Drug and Biological
Products
January 18, 2006
Today's Action
The Food and Drug Administration (FDA) today published a final rule,
titled "Requirements on Content and Format of Labeling for Human
Prescription Drug and Biological Products," in an effort to better
manage the risks of medical product use and reduce medical errors
associated with the use of prescription drug products.
Final Rule
FDA is revising the regulations governing the content and format of
prescribing information for human prescription drug and biological
products (21 CFR 201.56 and 201.57). The final rule requires that
the prescribing information of new and recently approved products
include
-
highlights of the prescribing information
(Highlights)
-
a table of contents (Contents)
-
reordering and minor content changes
-
minimum graphical requirements
Benefits of the Revisions to the Prescribing Information
The final rule is part of FDA's strategic initiative to manage the
risks of medical product use and reduce adverse events involving the
products it regulates. The revisions will make it easier for
healthcare professionals to access and use information contained in
the prescribing information, thereby increasing the extent to which
they rely on it to obtain information. FDA believes the revisions to
content and format of the prescribing information will enhance the
safe and effective use of prescription drug products and, in turn,
reduce the number of adverse reactions resulting from medication
errors due to misunderstood or incorrectly applied drug information.
Revisions to the Prescribing Information
The
“Highlights” section will provide immediate access to the information that
healthcare professionals most commonly refer to and view as most
important. This summary typically will be one half page in length.
Additional innovations provided in Highlights include:
-
The date of approval of the original drug product
-
Recent Major Changes, a list of all substantive
changes made within the past year to the following sections of the
prescribing information: Boxed Warning, Indications and Usage,
Dosage and Administration, Contraindications, and Warnings and
Precautions. These changes will be identified in the full
prescribing information as well.
-
Adverse drug reaction reporting contact information
The
“Contents” section will serve as a navigational tool to reference all the
sections and subsections in the full prescribing information, some
of which will not be referenced in Highlights.
Reorganization and format changes to the prescribing information
include:
-
The information practitioners refer to most
frequently and consider most important (e.g. Boxed Warning,
Indications and Usage, Dosage and Administration, and Dosage Forms
and Strengths (separated from Storage and Handling)) will be located
at the front of the prescribing information.
-
Risk information will be consolidated. The Adverse
Reactions section will follow after the Warnings and Precautions
section, consolidating risk information in one location and helping
to put in context the relative seriousness of the adverse reactions
discussed.
-
Other information formerly found in the Precautions
section will be located in sections devoted to Use in Specific
Populations, Drug Interactions, and Patient Counseling Information.
-
A separate Patient Counseling Information section
will be added to the requirement that all FDA-approved patient
information be reprinted in or accompany the drug product's prescribing information.
The purpose of this change is to increase the prominence of patient
information. The rule regarding the inclusion of all FDA-approved
patient information applies also to older products not otherwise
subject to the new content and format requirements.
-
There will be standardized bolding, white space, and
established minimum font sizes to enhance communication of important
information.
Implementation Initiative
In coordination with the publication of the final rule, FDA today
published four guidance documents.
-
Labeling for Human Prescription Drug and Biological
Products -- Implementing the New Content and Format Requirements.
This draft guidance focuses on, among other things, how to determine
what information should be presented in Highlights.
-
Adverse Reactions Section of Labeling for Human
Prescription Drug and Biological Products - Content and Format. This
final guidance focuses on how to organize the large body of complex
information that is typically contained in the "Adverse Reactions"
section and discusses how to determine whether a reported adverse
event should be included in the "Adverse Reactions" section.
-
Clinical Studies Section of Labeling for Human
Prescription Drug and Biological Products - Content and Format. This
final guidance focuses on how to select the studies that are
appropriate for inclusion in the "Clinical Studies" section and what
information should be provided for those studies.
-
Warnings and Precautions, Contraindications, and
Boxed Warning Sections of Labeling for Human Prescription Drug and
Biological Products - Content and Format. This draft guidance
focuses on how to determine whether an adverse reaction should be
discussed in the "Warnings and Precautions," "Contraindications," or
"Boxed Warning" sections and what information should be provided for
the adverse reaction.
FDA also has developed several prototypes (or
examples) of prescribing information that illustrate approaches to
complying with the content and format requirements. These and other
educational materials will be posted in a dedicated area on the FDA
Web site. Furthermore, FDA plans to engage in external outreach and
training for industry, physicians, and interested consumers, in
addition to internal training programs for FDA reviewers.
The content and format revisions to the prescribing information are
a key component of FDA's initiatives designed to make prescribing
more error-free and better informed by using new information
technology. For example, on November 2, 2005, the FDA began
requiring drug manufacturers to submit prescription drug labeling
information to the FDA in a new electronic format. Using embedded
computer tags and standardized medical terminology, the new format
will enable physicians to quickly search and access specific
prescribing information and thereby help reduce medication errors.
The new electronic product labels will be the key element and
primary sources of medication information for "DailyMed," a new
interagency online health information clearing house created
cooperatively by the FDA and the National Library of Medicine (NLM)
for the benefit of patients and healthcare professionals. "DailyMed"
can be accessed for free at
http://dailymed.nlm.nih.gov.
 Back
to Top 
Prescription Drug
Labeling
Date created: January 18, 2006 |
|
