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JAMA. 1998;279:645.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has announced the availability of a draft guidance for industry entitled, "Promoting Medical Products in a Changing Healthcare Environment: Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs)." This document provides guidance to the pharmaceutical industry and other sponsors of regulated medical products by describing circumstances in which they may be held responsible for promotional activities performed by health care organizations or PBMs.

The FDA regulates the promotional activities of medical product sponsors. Promotional materials disseminated to health care providers and patients may result in inappropriate medical decisions if the information is false, misleading, or promotes an unapproved use. For example, "switching" patients' prescriptions from one product to another could lead to serious health implications if such medical decisions are influenced by invalid medical product information.

The draft guidance proposes that manufacturers should be responsible for promotional activities performed by their subsidiaries. In addition, they . . . [Full Text of this Article]

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