committee devoted to advising the agency (and CDER specifically) on public communication issues that arise during the lifecycle of drugs.

The committee remains perplexed about the tasks of the new DSB, and how they relate to the center’s other plans for improving communication. The DSB, discussed in Chapter 3, has the dual purpose of addressing disagreements among CDER offices or divisions and assisting the center in communicating about drug safety issues to patients (Meadows, 2006; Throckmorton, 2006). As the committee noted in Chapter 3, assigning the two functions to the same internal body may not be effective. Both sets of activities require substantial expertise and resources, and from a management point of view, it seemed unusual that the two functions would be assigned to the same group. Although the committee realizes that the appearance of internal CDER conflict over how drug safety issues are identified, defined, and addressed became associated in the press with poor and delayed communication to the public about those drug safety issues, the committee believes that these two areas should be managed separately. Also, the DSB does not possess substantial expertise in the area of risk communication and consumer or patient behavior. For these reasons, the committee believes that a separate, external entity is needed to advise the agency on the diverse communication needs of the public and patients and on the best evidence on risk communication tools and strategies.

Several FDA centers, including CDER, the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH), share similar communication challenges. An advisory committee on consumer and patient communication issues could have a dual function, serving as a conduit for public input into FDA’s decision making (for example, through surveys), and an advisor to the agency on a range of communication issues. Other government agencies have advisory committees that involve consumers and patients (see Box 6-5).

The presence of consumer representatives in FDA’s advisory committee process is limited to one member per committee, and communication issues understandably constitute just a small component of advisory committees’ work. We believe that the agency, and especially CDER, would benefit from having a new advisory committee focused entirely on communication with the public, including risk communication. Public communication issues cut across CDER, CBER, and CDRH such as when and how to warn, how and what to communicate, so the proposed committee should serve all relevant centers.

6.1: The committee recommends that Congress enact legislation establishing a new FDA advisory committee on communication with patients and consumers. The committee would be composed of members who represent consumer and patient perspectives and



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