M e d i c i n e A ve 2 statements and claims made about prescription drugs, biotech products, and medical devices present truthful information about what a product will do, what its limitations are, and what unwanted effects may attend its use. Reference to unwanted effects in this context means any information that is known about adverse effects or risks of use, including contraindications, side effects, warnings or precautions, important notes, etc., that are contained in the labeling or prescribing information (PI) for a product. Advertising and Labeling The FD&C Act does not use the term promotion; the law only distinguishes advertising—ie, communications which appear in third-party paid media (eg, professional journals, magazines, other periodicals, and newspapers) and on the Internet (eg, third-party Web pages)—from labeling, which not only includes a product's label, but also all other communications that are not advertising, sometimes referred to as promotional labeling (eg, a book or booklet, a direct mail piece, a detail or sales aid, etc.) This distinction is important because the law requires for labeling a full description of a drug's wanted and unwanted effects, while the limitations of advertising media are recognized by FDA, and a lesser degree of disclosure is required. For print media, such disclosure is called a brief summary, while for broadcast media (which includes telephone communication systems) a major statement satisfies the regulatory requirements for "adequate dissemination" of full information—ie, leading a reader or listener to more comprehensive information by means of a toll-free number or a link to a Web site. It should be noted, however, that because the law is written broadly, it permits a wide range of regulatory discretion for interpretation and enforcement by FDA officials, 54
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