Thursday, August 10, 2006

FDA task force on how to communicate … among other things

The Food and Drug Administration has just formed an internal task force to help them develop a better understanding of recent developments in nanotech and of the regulatory issues surrounding the nanosize materials ... and, more as an afterthought, it seems, to develop strategies for successfully communicating with the public.
“Acting Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., today announced the formation of an internal FDA Nanotechnology Task Force. The new task force is charged with determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials.

The task force will identify and recommend ways to address any knowledge or policy gaps that exist so as to better enable the agency to evaluate possible adverse health effects from FDA-regulated products that use nanotechnology materials. FDA will continue to address product-specific nanotechnology-related issues on an ongoing basis.

‘As this exciting new area of science develops, FDA must be positioned to address both health promotion and protection challenges that it may present,’ said Dr. von Eschenbach. ‘Through this task force, we are leveraging our expertise and resources to guide the science and technology in the development of nanotechnology-based applications.’”

(click here for the full release; the first step will be a public hearing on October 10 of this year)

And the list of challenges that the task force is charged with includes virtually every issue surrounding the science of nanotechnology and its societal impacts. This is a step in the right direction, since it acknowledges that emerging technologies, such as nanotech, are increasingly debated as political rather than scientific issues.

But an exploratory internal committee like this only makes sense, if the FDA plans to appoint topic-specific advisory boards later on. These would obviously include advisory boards and task forces in the natural sciences. But they will also have to include expert panels from the social sciences on public attitudes and on successful communication with the general public.

Understanding the scientific implications or nanotechnology and having a functioning regulatory system in place is half of the battle. The other half is communicating successfully with the public about what regulations are needed and what kinds of research are being done. As I have argued before, public communication does not happen in a vacuum. It is a competition among interest groups, governmental agencies, scientific associations, and other players in the policy arena over limited space on the public agenda, and over which frames will dominate public discourse.

Let's hope the FDA task force will pay close attention to these issues. Communication researchers at places like Wisconsin or Cornell have been doing cutting-edge research for decades on public attitudes toward emerging technologies and on how to successfully communicate with various publics. To not capitalize on this expertise through specific task forces or committees would be shortsighted at the very least, especially given some of the communication debacles surrounding biotech, stem cell research, and the Intelligent Design debate.

Here’s the list of specific goals for the FDA task force ... including public communication, if you scroll all the way down:
  • Chair a public meeting to help FDA further its understanding of developments in nanotechnology materials that pertain to FDA-regulated products, including new and emerging scientific issues such as those pertaining to biological interactions that may lead to either beneficial or adverse health effects. This public meeting is scheduled for October 10.
  • Assess the current state of scientific knowledge pertaining to nanotechnology materials for purposes of carrying out FDA's mission.
  • Evaluate the effectiveness of the agency's regulatory approaches and authorities to meet any unique challenge that may be presented by the use of nanotechnology materials in FDA-regulated products.
  • Explore opportunities to foster innovation using nanotechnology materials to develop safe and effective drugs, biologics and devices, and to develop safe foods, feeds, and cosmetics.
  • Continue to strengthen FDA's collaborative relationships with other federal agencies, including the agencies participating in the National Nanotechnology Initiative such as the National Institutes of Health (NIH), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA), as well as with foreign government regulatory bodies, international organizations, healthcare professionals, industry, consumers, and other stakeholders to gather information regarding nanotechnology materials used or that could be used in FDA-regulated products.
  • Consider appropriate vehicles for communicating with the public about the use of nanotechnology materials in FDA-regulated products.
  • Submit its initial findings and recommendations to the Acting Commissioner within nine months of the public meeting.

0 comments: