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 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 “labeling,” 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) accompanying 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 supple- ments or explains it, in the manner that a committee report of the Congress accompanies a bill. No physi- cal 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 manufacturer 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
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