Earlier this year, the FDA announced the formation of a new advisory committee – the Risk Communication Advisory Committee and put out a call for nominations for potential members. They have now filled the roster and it is worth taking a moment to look at it for some hints as to what is hoped for this committee. Note, unlike other advisory committees, none of the members CVs are yet available for public examination on line.
There are experts on risk communication and perception, health literacy, behavioral medicine and even someone from Good Morning America. It will be interesting to watch the committee work and how the FDA uses them to advise on RiskMaps and risk reduction during advisory committee meetings. Companies with products in pipeline for next year would be well advised to analyze developments with this committee closely.
Here, by the way, is the mandate of the Risk Communication Advisory Committee according to its charter.
The Committee advises the Commissioner and designees on strategies and programs designed to communicate with the public about the risks and benefits of FDA-regulated products so as to facilitate optimal use of these products. The Committee also reviews and evaluates research relevant to such communication to the public by both FDA and other entities. It also facilitates interactively sharing risk and benefit information with the public to enable people to make informed independent judgments about use of FDA-regulated products. (emphasis added)
Here is the mandate of the pre-existing Drug Safety and Risk Management Committee according to its charter:
The Committee advises the Commissioner of Food and Drugs on risk management, risk communication, and quantitative evaluation of spontaneous reports for drugs for human use and for any other product for which the Food and Drug Administration has regulatory responsibility. The Committee also advises the Commissioner of Food and Drugs regarding the scientific and medical evaluation of all information gathered by the Department of Health and Human Services and the Department of Justice with regard to safety, efficacy, and abuse potential of drugs or other substances, and recommends actions to be taken by the Department of Health and Human Services with regard to the marketing, investigation, and control of such drugs or other substances. (emphasis added)
It would appear that the new committee will be going more into depth on the science of risk communications than the Drug Safety Risk Management Advisory Committee. Or, it could be that where one committee is good, two are better.
How many committees do we need to explain risk? Which, in turn, leaves the question these days, whether or not we need a committee to communicate benefit – just to balance things out a bit.
