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Regulatory Changes in Direct-To-Consumer Marketing of Pharmaceuticals

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Direct-to-consumer (DTC) marketing of pharmaceuticals has grown increasingly in the past decade. The American public views prescription drug advertising for a wide range of medical conditions, including high cholesterol, depression, allergies, and erectile dysfunction. The Federal Food and Drug Administration (FDA) regulates the content of these advertisements. Critics also have taken the position that the advertisements garner unearned trust from the public, are misleading, and promote unnecessary use of prescription drugs for common problems associated with aging. Proponents counter that DTC ads help eliminate stigmas associated with certain medical conditions, give patients an active role in their health care management, and …show more content…

The third and most common type is the “product claim ad,” which mentions the product and its indication and includes efficacy or safety claims.” (Ventola, Toxic par 3). These types of ads proved to be confusing and misleading for consumers. As Greene describes in “Hidden in Plain Sight”, “Over the course of the 1990s, resulting television and radio advertisements took on a surreal, disconnected quality, exemplified by the division of marketing for Schering-Plough's nonsedating antihistamine Claritin (loratidine): one set of advertisements praised promising new developments in antiallergy remedies but did not mention Claritin, while others featured the pill and its logo and promised “blue skies” without explaining what, in therapeutic terms, that might mean.”The FDA reacted to concerns over confusing DTC prescription drug ads by issuing final guidance in 1999, which relaxed previous regulations and redefined “adequate provision” of risks and benefits to include reference to a toll-free number or web site. (Greene, Hidden, par 34). The result of the relaxed regulations was an explosion of DTC pharmaceutical advertising in broadcast media. DTC rulings would be relaxed yet again in 2004, which saw the removal of the requirement to include complete prescribing information, instead requiring only a “simplified brief summary.” Ventola says “this change allowed pharmaceutical companies to present

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