M e d i c i n e A ve 2 John Kamp, Esq. and Wayne L. Fines For most of the history of medical advertising, the main government regulatory agencies that advertisers needed to focus on were the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA). A major transition took place with enactment of the 1962 Drug Amendments, which gave FDA the authority to regulate prescription drug advertising, a responsibility previously exercised by the FTC. For the next half century, advertisers and their agencies navigated FDA's regulations, guidances, podium pronouncements, and enforcement actions with varying degrees of success, as many of these set new policies. The main sanctions for alleged violations ranged from "Dear Doctor" or "Dear Healthcare Professional" letters to mandates for corrective advertising, with the underlying threat that the product could be seized or be the target of an injunction if the company failed to comply. Enforcement letters sometimes were accompanied by public announcements—announcements which not only created negative publicity for the company, but also 42
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