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FDA seeks advice on risk communication

Device Regulation Alert: Safety, Compliance and Reimbursement News, June 18, 2007

The FDA wants help improving risk communication. On June 4, the agency announced the formation of a new Risk Communication Advisory Committee charged with helping the FDA:

• Understand what the public needs from risk communications
• Develop "strategic plans to communicate product risks and benefits"
• Consider what research says about how to create risk/benefit communications
• Determine how to best explain risks and benefits to "vulnerable audiences"

An FDA press release attributes the committee's formation to recommendations included in an Institute of Medicine 2006 report "The Future of Drug Safety: Promoting and Protecting the Health of the Public."

The FDA defines the committee's mission to include not only drugs, but also all FDA-regulated products.

Federal Register notices will announce the committee's formation and seek nominations for membership. The group of 15 voting members will include patients, health care professionals, and consumers, as well as experts in the areas of risk communication, journalism, bioethics, and other related fields.

Nominees must provide a curriculum vitae and indicate that they have no conflicts of interest. FDA will examine nominees' financial interests, employment records, and other sources of potential conflicts of interest.

To read the release, click here.

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