FDA Appoints Risk Communication Advisory Committee

Spurred on by concerns from Congress, the Institute of Medicine (IOM), the pharmaceutical industry, physicians and patients, the Food and Drug Administration (FDA)has named an expert panel to advise it on developing better strategies and programs for communicating with providers and the public about the risks and benefits of regulated products, reports the Food and Drug Institute in an Insighter article on its website www.fdli.org.

The 15-member panel, chosen from a pool of more than 225 nominees, will be chaired by Baruch Fischhoff, Ph.D., Howard Heinz University Professor of Social and Decision Sciences at Carnegie Mellon University, writes freelance reporter Beryl Benderly. The committee is now in an organizational phase, and will be holding its first meetings in early 2008, sources tell the Food and Drug Law Institute (FDLI).

For several years, risk communication has presented FDA with vexing policy issues. During pubic hearings in late 2005 and early 2006, the comments criticizing its handling of risk communication issues. Then, in 2007, notes the Insighter piece, the IOM issued two reports that found fault with aspects of FDA's risk communications plan. "Current methods for generating and communicating information about medications are inadequate and contribute to the incidence of errors," stated the IOM's Preventing Medication Errors.

With the formation of this advisory committee, FDA has begun its formal response to its risk communication critics, experts say. "Ensuring effective communication about the risks and benefits of the products we regulate is one of our central responsibilities," says Randall Lutter, Ph.D., FDA's Deputy Commissioner for Policy and Planning. "While the IOM report focused on drugs and other medical products, we thought the value of an FDA Risk Communication Advisory Committee was so high. We expanded its scope to include communication regarding all regulated products," he tells FDLI.

The complete list of committee members is found in the Insighter article at www.fdli.org

FDLI is sponsoring a colloquium on risk communication, Communication Risk/Safety Information: How FDA Is Meeting the Challenge, Dec. 6 in Washington, D.C. At the meeting, key FDA officials, including Lutter and Deputy Commissioner and Chief Medical Officer Janet Woodcock will make presentations and engage in interactive dialogue with panelists from industry and law as well as attendees.

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Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal; the bimonthly magazine Update; FDA Directory; and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field.

SOURCE: Food & Drug Law Institute