Essentials of Healthcare Product Labeling
35
safe and effective use.17 To preserve the condition
of not being false or misleading, as stipulated
in the FD&C Act, labeling must be updated
whenever new information becomes available.18
It is important to appreciate that a product’s
prescribing information does not set the standard
of care for its indications and is only one resource
available to guide prescribers in their medical
practice. Further, once a prescription medicine is
approved for one or more indications, prescribers
sometimes use it for other, unapproved indica-
tions not included in the labeling, also referred to
as off-label use.19
The target readership of prescribing informa-
tion is healthcare professionals. However, it also is
closely read by others for a variety of reasons.
• Health authorities – In addition to the FDA,
labeling approved in the US serves as a ref-
erence for regulatory submissions elsewhere
in the world and may influence the content
of prescribing information in other regions.
• Pharmacovigilance professionals – Current
prescribing information is used as a refer-
ence in safety reporting to determine if an
adverse event is “labeled” or “unlabeled.”20
• Marketing – As the basis of promotional
activities, it will be used in the development
of marketing strategy.
• Competitors – Approved labeling will be
scrutinized for commercial purposes and
may be used as a starting point in the devel-
opment of labeling for new products.
• Liability attorneys – Labeling attracts the
close attention of liability attorneys both
within and outside the company.
While medical professionals’ needs should be the
primary focus when drafting prescribing infor-
mation, consideration of other audiences for this
document may influence decisions about content
and specific wording.
Preparing for Submission
Labeling content is developed by a cross-
functional team of professionals responsible for
various aspects of the product’s research, devel-
opment, marketing, and regulatory compliance.
Specifically, drafting the prescribing information
requires input from individuals who can speak
to underlying data from all research and devel-
opment stages. Marketing professionals will
identify key commercial messages based on brand
strategy. A team may need to involve a liability
attorney to ensure careful wording of certain text,
such as a particular warning, or provide other
legal guidance related to informing healthcare
professionals about the product. Medical affairs
professionals may be recruited in later labeling
development stages to suggest edits to wording
or expand content details to prevent confusion
for healthcare professionals unfamiliar with the
drug that otherwise would prompt questions to
the company. Finally, those directly responsible
for drafting the labeling manuscripts may be
individuals responsible for regulatory activities
supporting the product’s registration in the US,
such as US regulatory professionals, or they may
be dedicated labeling specialists, if a company has
such a department.
The team needs to carefully plan labeling
text development based on the expected avail-
ability of mature drafts of source documents.
Overviews and summaries are used most often as
source documents to support labeling statements,
as they synthesize information from individual
study reports written well before labeling text is
being finalized. Discrete study reports are used
when integrated documents do not support a
particular claim or statement in the prescribing
information. (All content must be scrupulously
annotated to sources that support the labeling
text. It is critical that the team collaborate closely
to ensure precise annotation to supporting
documents to substantiate every statement in the
prescribing information.)
The formal review process for prescribing
information (and any patient labeling the spon-
sor submits to the FDA) often involves senior
management from each functional area. Team
members should communicate their labeling
strategies to their functional management and
inform them about the status of supporting data
to ensure final labeling documents are aligned
with development objectives.
Reviews may be scheduled after labeling
sections are completed (e.g., nonclinical, clinical
35
safe and effective use.17 To preserve the condition
of not being false or misleading, as stipulated
in the FD&C Act, labeling must be updated
whenever new information becomes available.18
It is important to appreciate that a product’s
prescribing information does not set the standard
of care for its indications and is only one resource
available to guide prescribers in their medical
practice. Further, once a prescription medicine is
approved for one or more indications, prescribers
sometimes use it for other, unapproved indica-
tions not included in the labeling, also referred to
as off-label use.19
The target readership of prescribing informa-
tion is healthcare professionals. However, it also is
closely read by others for a variety of reasons.
• Health authorities – In addition to the FDA,
labeling approved in the US serves as a ref-
erence for regulatory submissions elsewhere
in the world and may influence the content
of prescribing information in other regions.
• Pharmacovigilance professionals – Current
prescribing information is used as a refer-
ence in safety reporting to determine if an
adverse event is “labeled” or “unlabeled.”20
• Marketing – As the basis of promotional
activities, it will be used in the development
of marketing strategy.
• Competitors – Approved labeling will be
scrutinized for commercial purposes and
may be used as a starting point in the devel-
opment of labeling for new products.
• Liability attorneys – Labeling attracts the
close attention of liability attorneys both
within and outside the company.
While medical professionals’ needs should be the
primary focus when drafting prescribing infor-
mation, consideration of other audiences for this
document may influence decisions about content
and specific wording.
Preparing for Submission
Labeling content is developed by a cross-
functional team of professionals responsible for
various aspects of the product’s research, devel-
opment, marketing, and regulatory compliance.
Specifically, drafting the prescribing information
requires input from individuals who can speak
to underlying data from all research and devel-
opment stages. Marketing professionals will
identify key commercial messages based on brand
strategy. A team may need to involve a liability
attorney to ensure careful wording of certain text,
such as a particular warning, or provide other
legal guidance related to informing healthcare
professionals about the product. Medical affairs
professionals may be recruited in later labeling
development stages to suggest edits to wording
or expand content details to prevent confusion
for healthcare professionals unfamiliar with the
drug that otherwise would prompt questions to
the company. Finally, those directly responsible
for drafting the labeling manuscripts may be
individuals responsible for regulatory activities
supporting the product’s registration in the US,
such as US regulatory professionals, or they may
be dedicated labeling specialists, if a company has
such a department.
The team needs to carefully plan labeling
text development based on the expected avail-
ability of mature drafts of source documents.
Overviews and summaries are used most often as
source documents to support labeling statements,
as they synthesize information from individual
study reports written well before labeling text is
being finalized. Discrete study reports are used
when integrated documents do not support a
particular claim or statement in the prescribing
information. (All content must be scrupulously
annotated to sources that support the labeling
text. It is critical that the team collaborate closely
to ensure precise annotation to supporting
documents to substantiate every statement in the
prescribing information.)
The formal review process for prescribing
information (and any patient labeling the spon-
sor submits to the FDA) often involves senior
management from each functional area. Team
members should communicate their labeling
strategies to their functional management and
inform them about the status of supporting data
to ensure final labeling documents are aligned
with development objectives.
Reviews may be scheduled after labeling
sections are completed (e.g., nonclinical, clinical