Upfront

Too often the Food and Drug Administration's announcements on the safety of Americans' food and medicines miss their mark, says psychologist and risk communication expert Baruch Fischhoff, PhD, of Carnegie Mellon University in Pittsburgh.

As chair of FDA's Risk Communication Advisory Committee, Fischhoff and two other psychologists, Ellen Peters, PhD, of Decision Research, in Eugene, Ore., and Craig Andrews, of Marquette University in Milwaukee, are answering the agency's call to update its communication strategy, making messages more useful and comprehensible. FDA has now drafted a new strategic plan with input from the committee's recommendations.

In the past, Congress's Government Accountability Office, the Institute of Medicine and others have criticized FDA for not explaining its decisions clearly enough for the public to make informed decisions about foods and drugs. FDA's communications are "accurate, [but] not as useful as they should be in order to take full advantage of FDA's great scientific expertise," Fischhoff says.

"We have the psychological science needed to communicate better," he says. "We are grateful that FDA is turning to us for help."

For example, many consumers are confused by what it means when FDA announces a recall. Most recalls are voluntary, Fischhoff explains. FDA only rarely orders a recall. Consumers also know little about FDA's resources for making inspections or how well manufacturers cooperate with its recommendations.

One topic that needs particular attention is communicating the degree of risks and benefits of different products, he says. For example, FDA recently decided that the smoking cessation drugs Chantix and Zyban should carry a label warning customers about side effects such as depression and suicidal thoughts. Fischhoff says that's valuable information, but isn't precise enough for consumers to properly weigh the risks and benefits.

In 2007, FDA created the 15-member communication committee, which includes three psychologists, as well as physicians, health researchers, communications experts and consumer advocates. So far, the committee has recommended that FDA:

• Develop the scientific work force needed to ensure effective communications.

• Provide a "drug facts box" for all prescription drugs, similar to the standard nutritional facts box required on food products.

• Evaluate the effectiveness of its communications, which include recalls, notices about potential complications, and licensing decisions.

• Work to address the needs of populations that might need supplemental information to the standard document, such older people or non-English speakers.

In April, FDA issued a draft of its updated "Strategic Plan for Risk Communication." Although full implementation of the committee's recommendations will be a slow process, Fischhoff says he's encouraged by the progress successes so far. He invites the public to follow his committee's advancements at its Web site.

—M. Price