M edi Kenneth R Berkowitz, Esq The saying "the more things change, the more they stay the same" is to a great extent a fitting description of the US Food & Drug Administration's regulation of advertising and promotion of prescription drugs and biologicals (collectively referred to as "prescription drugs" in this chapter). While major changes have occurred in the regulation of direct-to- consumer advertising (DTC) and off-label communications since 1990, and challenges remain on how best to regulate Internet communications, the basic tenets of regulatory requirements and their focus have remained essentially the same since the passage of the 1962 Drug Amendments. One of the major changes that has occurred during the last two decades is the entry of other federal regulatory agencies, state legislative and regulatory activities, and increased plaintiff's actions into areas formerly thought to be the exclusive province of FDA. The issue of whether FDA's decisions should trump any 52
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