Promotion of FDA-Regulated Medical Products 13
As introduced in Chapter 1, FDA approves both the
label and certain types of labeling for a new prescription
drug or biological product. While a layperson may not
be aware of the semantic difference between the terms,
“label” and “labeling” have distinct definitions under
the law and regulations governing prescription drugs
and biological products. The same is true for medical
devices, for which the device labels and Instructions for
Use (IFU) are reviewed and vetted by the agency as part
of the premarket approval or clearance process.
In general, all drug, biologic and medical device
labeling must not be “false or misleading,” must disclose
“material facts” and must include adequate warnings.
Table 2-1 provides a list of the most generally applica-
ble regulations for the labeling of prescription drugs
similar regulations have been codified for biological
products at 21 CFR Part 610 (General Biological
Standards), Subpart G (610.60-610.68). A list of
selected medical device labeling regulations is provided
in Table 2-2.
“Label” vs. “Labeling”
The FD& C Act defines “label” as “a display of writ-
ten, printed, or graphic matter upon the immediate
container of any article.”1 However, the container label
is only a subset of the broader legal concept of “label-
ing,” which is defined in the act as “all labels and other
written, printed, or graphic matters (1) upon any article
or any of its containers or wrappers, or (2) accompa-
nying such article.”2 In 1948, the US Supreme Court
interpreted that what Congress meant when it drafted
the phrase “accompanying such article” was meant to
be very broad, and that interpretation still is used today.
The Supreme Court found, “[o]ne article or thing
is accompanied by another when it supplements or
explains it, in the manner that a committee report of the
Congress accompanies a bill. No physical attachment
one to the other is necessary. It is the textual relationship
that is significant,” Kordel v. United States, 335 U.S. 345,
350 (1948). In practice, therefore, product materials
developed and disseminated by the product’s manufac-
turer or distributor are nearly always considered by FDA
to be “labeling” subject to the act and its implementing
regulations.
Prescription drugs and biologics are exempt from a
general requirement that drug labeling provide “ade-
quate directions for use” by a layperson, as long as the
labeling provides “adequate information for its use,
including indications, effects, dosages, routes, methods,
and frequency and duration of administration, and
any relevant hazards, contraindications, side effects,
and precautions under which practitioners licensed by
law to administer the drug can use the drug safely and
for the purposes for which it is intended, including all
purposes for which it is advertised or represented.”3
For prescription drugs, this requirement to provide
“adequate information” for the prescriber is met by the
inclusion of the FDA-approved PI, which always must
be included in or within the package from which the
drug is dispensed or administered.4
Importantly, because certain OTC drugs are
approved for marketing via the NDA pathway as
opposed to the more typical OTC Monograph pathway,
2
Fundamental Principles for Labeling and
Promotion of Prescription Medical Products
Part
I
Part
II
Part
III
Chapter
1
Chapter
4
Chapter
7
Chapter
2
Chapter
5
Chapter
3
Chapter
6
As introduced in Chapter 1, FDA approves both the
label and certain types of labeling for a new prescription
drug or biological product. While a layperson may not
be aware of the semantic difference between the terms,
“label” and “labeling” have distinct definitions under
the law and regulations governing prescription drugs
and biological products. The same is true for medical
devices, for which the device labels and Instructions for
Use (IFU) are reviewed and vetted by the agency as part
of the premarket approval or clearance process.
In general, all drug, biologic and medical device
labeling must not be “false or misleading,” must disclose
“material facts” and must include adequate warnings.
Table 2-1 provides a list of the most generally applica-
ble regulations for the labeling of prescription drugs
similar regulations have been codified for biological
products at 21 CFR Part 610 (General Biological
Standards), Subpart G (610.60-610.68). A list of
selected medical device labeling regulations is provided
in Table 2-2.
“Label” vs. “Labeling”
The FD& C Act defines “label” as “a display of writ-
ten, printed, or graphic matter upon the immediate
container of any article.”1 However, the container label
is only a subset of the broader legal concept of “label-
ing,” which is defined in the act as “all labels and other
written, printed, or graphic matters (1) upon any article
or any of its containers or wrappers, or (2) accompa-
nying such article.”2 In 1948, the US Supreme Court
interpreted that what Congress meant when it drafted
the phrase “accompanying such article” was meant to
be very broad, and that interpretation still is used today.
The Supreme Court found, “[o]ne article or thing
is accompanied by another when it supplements or
explains it, in the manner that a committee report of the
Congress accompanies a bill. No physical attachment
one to the other is necessary. It is the textual relationship
that is significant,” Kordel v. United States, 335 U.S. 345,
350 (1948). In practice, therefore, product materials
developed and disseminated by the product’s manufac-
turer or distributor are nearly always considered by FDA
to be “labeling” subject to the act and its implementing
regulations.
Prescription drugs and biologics are exempt from a
general requirement that drug labeling provide “ade-
quate directions for use” by a layperson, as long as the
labeling provides “adequate information for its use,
including indications, effects, dosages, routes, methods,
and frequency and duration of administration, and
any relevant hazards, contraindications, side effects,
and precautions under which practitioners licensed by
law to administer the drug can use the drug safely and
for the purposes for which it is intended, including all
purposes for which it is advertised or represented.”3
For prescription drugs, this requirement to provide
“adequate information” for the prescriber is met by the
inclusion of the FDA-approved PI, which always must
be included in or within the package from which the
drug is dispensed or administered.4
Importantly, because certain OTC drugs are
approved for marketing via the NDA pathway as
opposed to the more typical OTC Monograph pathway,
2
Fundamental Principles for Labeling and
Promotion of Prescription Medical Products
Part
I
Part
II
Part
III
Chapter
1
Chapter
4
Chapter
7
Chapter
2
Chapter
5
Chapter
3
Chapter
6