In a document released this Fall, the FDA laid out its Strategic Plan for Risk Communication. As noted in a posting last week, the plan states plainly the need for the FDA to move beyond its traditional parameters because of the fact that the speed and scope of the Internet demand a new paradigm.
As promising as that sounds, the road there is rather arduous. The FDA lays out three buckets in which they have piled 14 strategies. Those buckets are
- Strengthen the Science
- Expand FDA Capaicty
- Optimize FDA Policies
In addition to the 14 strategies contained within these buckets, the FDA has also identified over 70 actions that the agency plans over the coming few years to improve risk communications, 14 of which the agency is planning to accomplish over the next 12 months.
Strengthen the Science
- Produce research agenda for public dissemination and provide technical assistance and other support to facilitate research
- Develop an expert model to characterize tobacco-use related consumer decision-making and better understand the likely impact of FDA oversight of tobacco products
- Design the first of a series of surveys of the general public to assess their understanding of, and satisfaction with, FDA communications about medical products, to provide a template for regularly surveying significant FDA target audiences
- Create and maintain a useful, easily accessible internal database of FDA and other relevant risk communication research
Expand FDA Capacity
- Develop templates for FDA press releases about regularly occurring events (e.g., approvals, recalls, public health advisories/notifications
- Establish a significant new data collection mechanism to measure consumer reaction to food recalls and outbreaks on a just-in-time basis to adjust messages during the emergency for the greatest effectiveness
- Develop a "library" of multi-media communications on safe food practices for general education purposes, and for use in conjunction with crisis communications concerning food contamination episodes (e.g., safe handling of produce, food safety during power outages)
- Establish an internal network to test messages informally with FDA employees
- Improve procedures and mechanisms that enable FDA to conduct timely testing of public risk/benefit communications
- Develop FDA guidelines specifying roles and responsibilities of different FDA experts in communications development
- Post pictures of FDA regulated products affected by class I or high priority class II recalls as part of recall notices/information
Optimize FDA Policies
- Identify outcomes and develop measures for assessing progress toward goals and strategies
- Develop detailed action plans at agency and Center levels for implementing the strategies and achieving the proposed action steps, including timelines, responsibilities, and resource needs
- Harmonize across FDA on appropriate criteria, titles , content and format for public notifications of emerging risks of medical products (drugs, biologics and devices)
In addition, there are 56 other actions that will unfold over the next five years. What is surprising in this list of 14 is how many of these the FDA is not doing already – one would have thought that some of these were basic to operations now. In any case, it is notable how many of these are directed at food and how the regulation of food, in concert with so many changes on a broad scale, is about to change dramatically. Also, this is a good check list to come back to in a year to see how successful the agency is in implementing these 14 actions. The countdown begins.