Promotion of FDA-Regulated Medical Products Part I Part II Part III Chapter 1 Chapter 4 Chapter 7 Chapter 2 Chapter 5 Chapter 3 Chapter 6 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
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