The Committee advises the Commissioner of the Food and Drugs or designee on methods to effectively communicate risk associated with products regulated by the Food and Drug Administration and in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and any other product for which the Food and Drug Administration has regulatory responsibility. The Committee reviews and evaluates strategies and programs designed to communicate with the public about the risks and benefits of FDA-regulated products so as to facilitate optimal use of these products. It also reviews and evaluates research relevant to such communication to the public by both FDA and other entities, and facilities interactively sharing risk and benefit information with the public to enable people to make informed independent judgments about use of FDA-regulated products.
The Committee shall consist of a core of fifteen voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in fields such as social marketing, health literacy, and other relevant areas. Members will include experts on risk communication, experts on emerging post market drug risk and individuals knowledgeable about and experienced in the work of patient, consumer, and health professional organizations. Almost all non-Federal members of this committee serve as Special Government Employees. Some members will be selected to provide experiential insight on the communication needs of the various groups who use FDA-regulated products. The latter may include patients and patients' family members, health professionals, communicators in health, medicine and science, and persons affiliated with consumer, specific disease, or patient safety advocacy groups. The Commissioner or designee shall also have the authority to select from a group of individuals nominated by industry to serve temporarily as nonvoting members who are identified with industry interests. The number of temporary members selected for a particular meeting will depend on the meeting topic(s).
Designated Federal Officer
Ashlee Janusziewicz, PharmD
Advisory Committee Oversight and Management Staff
Office of the Chief Scientist
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Tel 301 796-7614
- FDA Advisory Committee Information Line
- (301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.