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Can FDA's New Plan Better Communicate Risk to Patients?

FDA has issued a Strategic Plan for Risk Communication, outlining the agency’s efforts to release more-meaningful public health information. The plan lays out a framework for  FDA to provide information about products to healthcare professionals, patients, and consumers. It also outlines how the agency oversees industry communications. The agenda involves 70 specific actions for the FDA to take over the next five years. The agency commits to accomplishing 14 of them over the next year.

Some of these immediate items relevant to medical devices include the following:

  • Designing a series of 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 a useful, easily 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.
  • Developing detailed action plans at the agency and center levels for implementing and achieving the proposed action steps, including timelines, responsibilities, and resource needs.
According to the press release, the plan reflects FDA's belief that risk communications must be adapted to the needs of different audiences and should be evaluated to ensure effectiveness.
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