The FDA today announced a Strategic Plan for Risk Communication that establishes a framework for communicating meaningful health information with the public about FDA-regulated products. Part of the plan also includes providing information about FDA-
regulated products to health care professionals, patients and consumers.
Margaret A. Hamburg, M.D., Commissioner of the FDA asserted that this plan will “communicate frequently and clearly the risks and benefits of certain products, and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health and well-being.”
According to their press release, the FDA plan has three key areas–FDA’s science base, its operational capacity and its policy and processes. The plan also identifies over 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 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;
- Developing an expert model to characterize tobacco-use related
consumer decision-making and better understand the likely impact of
FDA oversight of tobacco products;
- Developing a “library” of multi-media communications on safe
food practices for general education purposes and for use with crisis
communications concerning food contamination episodes;
- Posting pictures of FDA- regulated products affected by Class I
or high-priority Class II recalls as part of recall notices/information; and
- Developing detailed action plans at the agency and center
levels for implementing and achieving the proposed action steps,
including timelines, responsibilities and resource needs
The announcement of this plan seems strategically in place with a previously announced hearing on the Internet and Web 2.0 regarding how information about drugs and products are being conveyed to the public. Such a strategic plan is important for industry, physicians and patients because it will give health care providers more critical information about the products they use, it will help industry convey the risks associated with their products, and it will allow patients to make more educated decisions.