sponsors were left wanting more specificity about their products in the ads. The FDA Guidance document, while falling short of being a formal regulation, suggested alternatives to the brief summary requirement that a manufacturer might use as a means of meeting the disclosure requirements for broadcast advertisements, with the implied understanding that a manufacturer who followed these principles most likely would not be subjected to an enforcement proceeding. Under the Guidance, a sponsor may meet the adequate provision requirement by including the following four elements in any commercial: 1) A toll-free call-in number, 2) a statement that additional product information may be found in print ads appearing in magazines or newspapers that normally would be available to the intended audience, or that such information is available in doctors' offices, public libraries, etc, 3) an admonition to contact a physician or other healthcare professional for additional information, and 4) the address of a Web site with more information. Despite these extensive consumer protection provisions, in 1997 DTC immediately became the focus of intense, ongoing attacks by Congressional critics, some professional organizations, and consumer activists. These criticisms have continued unabated to the present day. The largely unsubstantiated attacks generally have focused on the alleged misleading nature of such advertising, or unproven charges that such advertising contributes to higher prescription drug prices. As use of the new advertising media increased, FDA used its traditional enforcement tools to guide the industry into compliance with its suggestions, sending enforcement letters to companies protesting certain promotional statements and practices. Leading FDA concerns about DTC claims include the overstatement of
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