on. Providers develop their knowledge about prescription drugs through a variety of means, including journal articles, interactions with company sales representatives, continuing education, professional associations, communication or education provided by their practice, hospital, or health system, and communiqués from FDA (either direct for those who request FDA electronic communications, or through professional associations that subscribe to or relay FDA’s public health advisories).

FDA communicates to the public and to providers about drug safety concerns through public health advisories and warning. Some components of FDA’s risk communication are under development, as described in Appendix A. For example, the agency has established a Drug Watch Web site intended for timely communication of safety issues to the public, but concerns arose about communicating complex issues of scientific uncertainty, explaining complex data clearly and in a way that is useful to patients (FDA, 2005). At the time of this writing, the committee had not yet learned of a resolution of these issues.

FDA has historically focused most of its communication activities on health care providers who prescribe FDA-approved drugs and serve as the “learned intermediary” between drug production and regulation and patients. That is evident in the dense, technical language of prescription drug labeling rules. In recent years, FDA has acknowledged the importance of communicating with and to patients and the general public by including them in its mission, which calls for “advancing the public health by … helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” FDA has also reoriented some of its information and communication toward patients and the public, and has held several public hearings on issues related to communication and DTC advertising.

At least three types of the Center for Drug Evaluation and Research (CDER) regulatory activities involve communication-related activities pertinent to patients and the public. First, FDA has authority over prescription drug advertising developed and published or broadcast by sponsors, and CDER’s Division of Drug Marketing and Communication sends untitled letters2 and warning letters to sponsors whose advertisements do not convey a fair balance of risk and benefit information. Second, all of FDA’s advisory committees include consumer representatives. Those committees’ meetings are open to the public and routinely include opportunity for public comment on the issues under discussion. Some committee meetings may address risk communication issues. Third, FDA provides information about prescription drugs and other FDA-approved therapies on its Web site, and in print information about prescription drugs in general on a very small scale.


See Chapter 5 for explanation.

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