New FDA committee to address risk communication

Jun 5 2007

The U.S. Food and Drug Administration (FDA) today announced a new advisory committee designed to counsel the agency on how to strengthen the communication of risks and benefits of FDA-regulated products to the public.

The Risk Communication Advisory Committee will;

• help FDA better understand the communication needs and priorities of the general public;
• advise FDA on the development of strategic plans to communicate product risks and benefits; and
• make recommendations to FDA on what current research suggests about crafting risk and benefit messages, as well as how to most effectively communicate specific product information to vulnerable audiences.

“Communicating the risks and benefits associated with FDA-regulated products is essential to help consumers and health care professionals make informed decisions,” said Randall Lutter, Ph.D., FDA's acting deputy commissioner for policy. “The Risk Communication Advisory Committee will bring together a broad range of experts and views to help improve FDA's communication of the science-based information about product risks and benefits that the public needs to make informed decisions.”

Establishment of the new Risk Communication Advisory Committee stems from the Institute of Medicine's (IOM) 2006 report, The Future of Drug Safety: Promoting and Protecting the Health of the Public. The report recommended that Congress enact legislation establishing a new advisory committee to address how FDA communicates information about the efficacy, safety and use of drugs and other FDA-regulated medical products. FDA agreed with the value of such a committee and acted promptly to establish it through more speedy administrative procedures. FDA also expanded the scope of the committee to cover communication of risks and benefits of all products regulated by the agency.

The advisory committee will be made up of 15 voting members that include experts and public members who are not affiliated with the FDA. Experts will include authorities knowledgeable in the fields of risk communication, social marketing, health literacy, cultural competency, journalism, bioethics, and other relevant behavioral and social sciences. Public members will include those who can provide the perspective of users of FDA-regulated products, such as consumers, patients, caregivers and health professionals.

Two related Federal Register notices are being published, one announcing the establishment of the new advisory committee and the other requesting nominations for members to serve on the committee. For information: http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.

Nominations for advisory committee members received on or before 45 days after the Federal Register publication will be given first consideration for membership.

For more information:

An overview of FDA advisory committees
www.fda.gov/oc/advisory/default.htm

FDA's full response to the IOM report
www.fda.gov/oc/reports/iom013007.html