Promotion of FDA-Regulated Medical Products 3
The first step toward understanding the requirements
for prescription drug and device labeling is having
some knowledge of the agencies involved in regulat-
ing those products. Although the US Food and Drug
Administration (FDA) is the most important, and cer-
tainly most prominent, regulator of prescription drugs
and devices, other federal agencies support and assist
FDA’s efforts to ensure the safety of patients who use
these products. This chapter provides a brief overview
of the regulatory agencies responsible for regulating
prescription drug and device labeling and enforcing
those requirements.
FDA: Primary Regulator of Prescription
Drugs and Devices
FDA is one of the executive agencies within the US
Department of Health and Human Services (HHS). It
is headed by a commissioner appointed by the presi-
dent, and reports to the HHS secretary. With respect to
medical products, FDA’s mission has multiple elements,
including: 1) ensuring the safety, efficacy and security of
drug, biologic and device products to protect the public
health 2) advancing public health by helping medical
product innovations get to market sooner and 3) giving
the public access to accurate scientific information nec-
essary to use medical products safely and effectively.1
The Federal Food, Drug, and Cosmetic Act (FD&C
Act), with its periodic amendments, is the primary
source of FDA’s authority, and grants the agency
broad jurisdiction over prescription drugs and medical
devices. Under the FD&C Act, a “drug” is defined as:
articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in
man or other animals...articles (other than food)
intended to affect the structure or any function of
the body of man or other animals [and any com-
ponents thereof]2
and a “device” is defined as:
an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other
similar or related article, including any compo-
nent, part, or accessory, which is...intended for use
in the diagnosis of disease or other conditions, or
in the cure, mitigation, treatment, or prevention of
disease, in man or other animals, or...intended to
affect the structure or any function of the body of
man or other animals, and which does not achieve
its primary intended purposes through chemical
action...and which is not dependent on being
metabolized for the achievement of its primary
intended purposes.3
FDA’s rulemaking authority extends to many aspects
of the drug and device industries, including, but not
limited to, manufacturing, distribution, labeling, pro-
motion and moving medical products or components
into or out of the US. This authority allows FDA to set
standards and requirements for operations relating to
drugs4 and devices,5 which are recorded in Title 21 of
the US Code of Federal Regulations (see Sidebar 1-1).
The FD&C Act enables FDA to inspect compa-
nies with drug, biologic and device operations and
1
Introduction to the Agencies Involved in
Prescription Drug and Device Labeling
Part
I
Part
II
Part
III
Chapter
1
Chapter
4
Chapter
7
Chapter
2
Chapter
5
Chapter
3
Chapter
6
The first step toward understanding the requirements
for prescription drug and device labeling is having
some knowledge of the agencies involved in regulat-
ing those products. Although the US Food and Drug
Administration (FDA) is the most important, and cer-
tainly most prominent, regulator of prescription drugs
and devices, other federal agencies support and assist
FDA’s efforts to ensure the safety of patients who use
these products. This chapter provides a brief overview
of the regulatory agencies responsible for regulating
prescription drug and device labeling and enforcing
those requirements.
FDA: Primary Regulator of Prescription
Drugs and Devices
FDA is one of the executive agencies within the US
Department of Health and Human Services (HHS). It
is headed by a commissioner appointed by the presi-
dent, and reports to the HHS secretary. With respect to
medical products, FDA’s mission has multiple elements,
including: 1) ensuring the safety, efficacy and security of
drug, biologic and device products to protect the public
health 2) advancing public health by helping medical
product innovations get to market sooner and 3) giving
the public access to accurate scientific information nec-
essary to use medical products safely and effectively.1
The Federal Food, Drug, and Cosmetic Act (FD&C
Act), with its periodic amendments, is the primary
source of FDA’s authority, and grants the agency
broad jurisdiction over prescription drugs and medical
devices. Under the FD&C Act, a “drug” is defined as:
articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in
man or other animals...articles (other than food)
intended to affect the structure or any function of
the body of man or other animals [and any com-
ponents thereof]2
and a “device” is defined as:
an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other
similar or related article, including any compo-
nent, part, or accessory, which is...intended for use
in the diagnosis of disease or other conditions, or
in the cure, mitigation, treatment, or prevention of
disease, in man or other animals, or...intended to
affect the structure or any function of the body of
man or other animals, and which does not achieve
its primary intended purposes through chemical
action...and which is not dependent on being
metabolized for the achievement of its primary
intended purposes.3
FDA’s rulemaking authority extends to many aspects
of the drug and device industries, including, but not
limited to, manufacturing, distribution, labeling, pro-
motion and moving medical products or components
into or out of the US. This authority allows FDA to set
standards and requirements for operations relating to
drugs4 and devices,5 which are recorded in Title 21 of
the US Code of Federal Regulations (see Sidebar 1-1).
The FD&C Act enables FDA to inspect compa-
nies with drug, biologic and device operations and
1
Introduction to the Agencies Involved in
Prescription Drug and Device Labeling
Part
I
Part
II
Part
III
Chapter
1
Chapter
4
Chapter
7
Chapter
2
Chapter
5
Chapter
3
Chapter
6