Instrument or Impediment?

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Abstract
At least one type of publication becomes important in some way to most writers involved with prescription drugs. I have in mind the monographs addressed to physicians and inserted into drug packages by manufacturers. These documents are technically part of the "labeling" of the respective drugs, and as such, their content is subject to regulation by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. Their purported mission is to inform physicians about the properties of the drugs and thus to lead to judicious prescribing practices. During the past decade, they have acquired a mystique that I propose to examine. In addition to labeling, these publications are variously spoken of as "package inserts," "package stuffers," or "full-disclosure statements." I think the termregulatory monographis a better designation, for reasons to be mentioned. However, that expression could be misleading unless there is an understanding about

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