information can make no medical claims, but only comprise an analysis that "identifies, measures or compares the economic consequences" of the product, including the costs of health outcomes or the use of the drug compared to another drug, to another health intervention, or to no intervention. The economic information can address only approved claims, not off-lahel uses. Direct-to-Consumer Advertising (DTC) In 1997, FDA announced a shift in its policies regarding the use of mass consumer media for the promotion of prescription drugs. Although technically such advertising had been permitted under the law for years, as the result of a "gentlemen's agreement" in the 1980s, DTC was the subject of a moratorium— a voluntary suspension of an otherwise legal activity. When a change in direction was signaled by FDA in 1997, pharmaceutical manufacturers vigorously took to the new medium. If specific prescription drugs are advertised, the ad must state that the products are only available by prescription from a healthcare professional authorized to prescribe the product. Furthermore, all of the legal and regulatory requirements for prescription drug advertising directed to healthcare professionals must be adhered to. In print advertising, fair balance must be clearly shown, and a brief summary of contraindications, warnings, precautions, and side effects must accompany the ad. In the case of broadcast advertising, a major statement which includes disclosure of a product's major risks must be provided, usually by a voiceover or text shown on the screen, along with either a brief summary or adequate provision for the dissemination of the package insert. For other promotional material directed to consumers, complete prescribing information is required, as is fair balance. A new category of disclosure, approved patient
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