2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
FDA Comment Number : EC5
Submitter : Ms. Susan Kleimann, Ph.D. Date & Time: 11/18/2005 02:11:20
Organization : Center for Plain Language
Category : Consumer Group
Issue Areas/Comments
As Director of the Center for Plain Language, a non-profit organization, I would like to speak to the need for clear and precise language. I examined the Patient Information Sheet which fails on a number of different levels in terms ot reaching potential audiences. The information is critical--the side effects of Adderall are serious, including sudden death, abuse, and even worsening mental illness. However, the opening page of the alert fails to highlight this information in such a way as to attract attention and, in fact, seemingly buries this critical information in a paragraph filled with long and technical words, such as "underlying cardiac abnormalities."

The critical nature of the information suggests that the currrent notice needs to be reordered, the language simplified, and the sentence structure further simplified. Restructuring or reordering of the informaiton would organize accoording to the questions a typical reader (or seeker) of this information, would have--with the most important information first. This question might be "why should I care about the informaiton on this page?" or "Why should I read this information?" The goal is to move the exigence of the notice to a more prominent place.

Words also need to be simplified, since few of the sentences on the front page are simple and direct. In addition, the document shifts the person to whom it is addressed. The first page seems to be a third person address, potentially to the parents of children, but the second page introduces the direct address form of "you." In addition, the document needs to be organized so that the reader can find informaiton without scrolling through the entire document. The use of a small listing of headings could provide that overview information that could orient a reader to the entire document. A solid redesign would look at how to organize the information so that a reader could skip to the portions that are central to his need.

Since consumers are the ultimate users of this document, I would strongly advocate testing the document with some of the intended audience. Withg relatively small numbers of readers, the format and template of a new design could be tested to ensure that the format, the content, and the design work in unison to help the reader pay attention to, comprehend, and use the information contained. Afterall,. the ultimate measure of the document's success is the reader.

All of these characteristrics of the document itself suggest that the use of plain language and the application of good document design principles would be able to make these docvuments more accessible to all--including those of low literacy--and testing could verify the point.

For the hearing, I would bring a rewrite of the document suggesting both an order and offering a simplification of the language,