levels, from a variety of ethnic, racial, income, and health experience backgrounds.

The Food and Drug Administration The FDA regulates and provides information about drugs, biological products, medical and radiological devices, the food supply, and cosmetics. Three general areas of FDA activity related to health literacy are advertising, outreach, and labeling.

  • Advertising. Advertising for prescription drugs is regulated by the Code of Federal Regulations (21 CFR 202) and is enforced by the FDA. Criteria indicate that both print and broadcast advertisements must not be misleading, must provide balanced information about risks and benefits, must state the major risks, and, for print advertisements, must contain a brief summary statement of effectiveness. Broadcast advertisements also are required to include “adequate provision” for methods to obtain more detailed information, such as through a print ad, a toll-free telephone number, or by asking a health-care provider.

  • Outreach. Outreach to consumers and patients is a central activity for the FDA. The FDA develops public service campaigns and announcements, maintains web information for consumers, and carries out educational programs on specific topics. Challenges to successful consumer outreach at the FDA include: getting information to a wide variety of consumers with different needs, abilities, and desires; encouraging consumers to use the information; simplifying information without losing meaning or becoming too lengthy; and ensuring balance between risks and benefits (Lechter, 2002).

  • Labeling. The FDA approves and has legal jurisdiction over the content of labels for prescription and over-the-counter medications as well as biologics and medical devices. Aspects of medication labeling overseen by the FDA include medication guides, patient package inserts, and the standardized over-the-counter Drug Facts format. The FDA also performs research on label comprehension and the actual use of labels by consumers, monitors the prescription information provided to consumers by the private sector, carries out consumer outreach, and monitors prescription drug advertising.

An FDA regulation requires that over-the-counter medication labels be written: “… in such terms as to render them likely to be read and understood by the ordinary individual, including individuals of low comprehension, under customary conditions of purchase and use.”17 The sponsor or


21 CFR 330.10(a)(4)(v).

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