Medicine Ave 2

labeling, generally can be used in place of the more technical brief summary used in professional advertising, so long as it complies with the regulations. Patient labeling that is primarily intended as instructions for use or that focuses on a single warning is too narrow to substitute for an approved brief summary. Broadcast Advertisements A special comment is warranted on radio, TV, telephone, and Internet communications—ie, broadcast advertisements. In July 1997, FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) provided Draft Guidance for industry on consumer- directed broadcast advertisements. Hundreds of comments were received by FDA before the guidance was finalized, with little change, on August 6, 1999. The clash between regulatory requirements and the nature of broadcast/electronic communications quickly became evident as sponsors struggled to satisfy the regulators while using the new media to their greatest effect. The time and cost of scrolling a lengthy brief summary on television or reading it on the radio or telephone forced advertisers to request discussions with FDA to improve utilization of these media. In the meantime, drug manufacturers experimented with reminder ads—ads that call attention to the nature of the drug product only, and do not include indications for use or dosage recommendations— and help-seeking ads, which include a description of a disease or condition and the admonition to "see your doctor" to learn about available treatments, but nothing about the potential treatment itself. Surprisingly, these ads aroused substantial interest, prompting patients to visit doctors for more information, and led to earlier disease diagnoses. From a marketing perspective, however,

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