manufacturer of a medication is responsible for producing labels that comply with this requirement, and may conduct label comprehension studies that require the participants to apply the label information in hypothetical situations. The FDA reviews the results of these studies in order to strengthen the label, and to determine whether the medication can safely and effectively be used without professional guidance. Participants in the studies include individuals with “low comprehension” as required by the regulation mentioned above. Low comprehension is typically defined as having an eighth-grade reading level or below, and the Rapid Estimate of Adult Literacy in Medicine (REALM) is frequently used to make this determination.

The Centers for Disease Control and Prevention As the lead public health agency of the United States, the CDC has a central role in successfully communicating information on health and illness to all members of the public. The CDC identifies “Providing credible information to enhance health decisions” (CDC, 2003) as one of the central goals of its mission. Related to health literacy, the CDC’s focus has encompassed efforts around plain language including training, testing and pre-testing materials, surveys, and the provision of health information to TV shows, networks, writers, and producers. The CDC has addressed issues of culture in several of its programs. For example, the National Institute for Occupational Safety and Health added a Spanish-language section to its web site in 2001, and the National Immunization Program developed educational material for American Indians and Native Alaskans in 2003. Currently, CDC is redesigning its web site based on a CDC web evaluation completed in 2002. The evaluation showed that consumers looking for basic health information regarding disease and disease prevention are the largest segment of visitors to the CDC web site.

The National Institutes of Health The National Institutes of Health (NIH) play the crucial role of determining federal funding for health literacy research, and thus in large part set the research agenda on the topic in the United States. Figure 6-3 shows NIH funding of health literacy over the past 6 years.18 These data were derived from a search of the NIH CRISP database from 1993 to 2002 using the following operands: “health literacy,” “health and literacy,” “health and readability,” and “literacy and readability.” The grants retrieved were examined for relevance to the field


The committee thanks Patrick Weld and K. Visnawath, Ph.D., of the National Cancer Institute for their contributions to this section of the report. Mr. Weld and Dr. Viswanath performed this search and analysis of the CRISP database. An expanded description of the methods of their work can be found in Appendix A.

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