organizations. The advisory committee would advise CDER and other centers on communication issues related to efficacy, safety, and use during the lifecycle of drugs and other medical products, and it would support the centers in their mission to “help the public get the accurate, science-based information they need to use medicines and foods to improve their health.”


The proposed advisory committee should also have the role of developing and implementing a comprehensive consumer information program at FDA. The expertise needed on the advisory committee may include consumer and patient perspectives (adult, children, chronic conditions, new reader, consumer organizations, disease specific advocacy groups, and patient safety advocacy groups), risk communication, health literacy, social marketing expertise, public relations expertise, social sciences expertise with an emphasis on qualitative research and survey science, journalism, and ethics. The advisory committee could develop standards for effective communication of risk and benefit information, patient-provider communication, and patient participation in the generation of drug safety information and data, and apply available expertise and evidence to refine the structure and content of public health advisories, develop more robust standards for FDA’s assessment of DTC advertising. It would, like all other advisory committees, be based in the Office of the Commissioner, but it would work closely with the new CDER Office of Safety Policy and Communication.7

The scope of work for the new CDER Office of Safety Policy and Communication is still under development. Given the reactive, fragmentary, and short-lived nature of previous CDER initiatives and organizational changes, the committee believes that special attention and commitment will be required to allow the new office to succeed. It will be essential to have its scope and goals clearly defined, and for its work to be given a high priority in CDER.

6.2: The committee recommends that the new Office of Drug Safety Policy and Communication should develop a cohesive risk communication plan that includes, at a minimum, a review of all center risk communication activities, evaluation and revision of communication tools for clarity and consistency, and priority-setting to ensure efficient use of resources. The work of the office should be evaluated after one year.

7

The Advisory Committee Oversight and Management Staff in the Office of the Commissioner works in collaboration with FDA centers to ensure consistent development, implementation, and operations of the FDA advisory committees (FDA, 2003).



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