BOX 6-4

Criteria for Useful Consumer Medication Information

Written prescription medicine information should be

  1. scientifically accurate

  2. unbiased in content and tone

  3. sufficiently specific and comprehensive

  4. presented in an understandable and legible format that is readily comprehensible to consumers

  5. timely and up-to-date

  6. useful

SOURCE: Steering Committee for the Collaborative Development of a Long-Range Action Plan for the Provision of Useful Prescription Medicine Information (1996).

One function of the DSB (described in more detail in Chapter 3), now located in the Office of Safety Policy and Communication, is to produce patient information sheets for every drug, to be posted on the FDA/CDER Web site. The sheets are intended to provide safety alerts and other emerging information to consumers about specific drugs. However, a footnote to the Drug Watch guidance developed by CDER seems to suggest that the center’s long-term goal is to develop patient information sheets (and provider sheets) for every drug on the market (FDA, 2005; Galson, 2005; confirmed by S. Galson, personal communication, February 22, 2006).

Improving Communication with the Public

CDER uses the expertise of 17 advisory committees (and the Drug Safety and Risk Management advisory committee) charged with advising FDA and the center on issues related to broad classes of drugs (such as oncologic, cardiovascular, and renal). Although communication issues related to specific drugs may emerge in the committees’ work, the existing committees are chartered to review and evaluate safety and efficacy data (on marketed or investigational human drug products) and to make recommendations to the agency.6 The committee has found a 1996 reference to an FDA Committee on Patient Education (1996). To our knowledge, there is no advisory


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