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 encourages the doctor/patient relationship. There have been calls for bans on DTC pharmaceutical advertising, but the practice is protected under a business’s right to free speech. Regulation changes, particularly requiring the FDA to pre-approve marketing campaigns before they are released to the public, may be one way to appease opponents, while protecting the rights of pharmaceutical manufacturers to advertise to the average American consumer.
The FDA was given the authority to approve pharmaceutical products for marketing in the U.S. as a result of the Federal Food, Drug, and Cosmetic Act, passed in 1938 (FDA par 2). In 1960’s, the agency issued final regulations for prescription drug advertising, which stipulated that these ads must not be false or misleading, present a “fair balance” of information describing both the risks and benefits of a drug, include facts that are “material” to the product’s advertised uses, and include a “brief summary” that mentions every risk described in the product’s ...

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