Failure to satisfy the FDA's requirements and requests for specific wording and cautionary statements can delay a product's approval and launch into the market, and this delay can translate into a tremendous finacial loss to a pharmaceutical manufacturer. A package insert, as currently written, is usually viewed by the lay public as little more than a folded piece of paper found in the box containing a drug. Few members of the public can understand, without the aid of a medical dictionary, the abstruse information concerning pharmacology and pathology that is contained in the package insert. Even physicians have found the package insert a literary conundrum. The medical writer, however, should view the package insert as a synopsis of the key physicochemical, pharmacological, clinical efficacy, and clinical safety properties of the prescription drug, a synopsis that has the potential to be highly readable, consistent with the requirement of the FDA, and helpful to clinicians who wish to search the document for specific information.
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