FDA outlines new risk communication plan

The FDA has issued its strategic plan for risk communication, which outlines the agency’s efforts to lay out a framework to provide information about FDA-regulated products to healthcare professionals, patients and consumers.

The plan defines three areas: science base, operational capacity and policy and processes, in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies more than 70 specific actions for the FDA to take over the next five years, including 14 that the agency commits to accomplishing over the next year.

They include:

• Designing surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products;
• Producing a research agenda for public dissemination;
• Creating and maintaining an accessible internal database of FDA and other relevant risk-communication research;
• Posting pictures of FDA-regulated products affected by Class I or high-priority Class II recalls as part of recall notices/information; and
• Developing action plans at the agency and center levels for achieving the action steps, including timelines, responsibilities and resource needs.

The agency said that the plan reflects its “belief that risk communications must be adapted to the needs of different audiences and should be evaluated to ensure effectiveness.” The plan also focuses on improving two-way communication through enhanced partnerships with government and non-government organizations.