FDA Deputy Commissioner Gottlieb Addresses FDA/CDRH on Risk Communication
MedSun: Newsletter #10, December 2006

Food and Drug Administration (FDA) Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., opened the September 26, 2006, Center for Devices and Radiological Health (CDRH) Workshop on Risk Communication in North Bethesda, Maryland. Noting FDA’s fundamental role of information management, Dr. Gottlieb applauded FDA’s staff as world-class in collection and analysis of data, understanding the risks and benefits posed by medical products, and providing recommendations on appropriate product use. “But,” he added, “when it comes to providing the information needed to help consumers make everyday choices and decisions about the health care products that they use, our analysis is only as valuable as our ability to effectively communicate it.”

For too long, according to Dr. Gottlieb, attention was focused on improving the hard sciences without working to advance the social sciences, particularly as regards risk communication. In the case of devices, for example, FDA must rethink the recall language “…as the complexity of the products that we regulate increases and the nature of the incremental innovation inherent in medical devices becomes an even more iterative process.” “What is the best way to communicate this information to patients and providers so they can most effectively incorporate this fundamental nature of device complexity into their decisions to use a medical product?” he asked.

Dr. Gottlieb then reviewed FDA’s application of new resources and new approaches to risk communication, including increased accessibility of senior scientific and medical staff during important safety-related announcements, media conference calls, direct outreach to physician groups, and provision of regular public health advisories. The growing complexity of FDA’s work and the concomitant communication demands are a challenge for the agency, which is increasingly called upon to discuss issues that are still under investigation. Full information must be available for patients and care providers on medical products, so FDA will develop communication means that carefully “calibrate the language and the tools” used to discuss risks involved in products or information.

“Overwarning about risk can be as dangerous as underwarning, by discouraging the safe use of medical products that we know have proven benefits. The exercise of speaking about these interim risks and unsettled science requires the agency to constantly strike to achieve clarity, candor, and humility in all of its communications,” said Dr. Gottlieb.

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