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Does It Really Require 15 People to Communicate?
FDA this week announced the formation of a 15-member committee to advise it on how to improve communication regarding risks and benefits of medical devices and other products the agency regulates.
June 6, 2007
1 Min Read
FDA this week announced the formation of a 15-member committee to advise it on how to improve communication regarding risks and benefits of medical devices and other products the agency regulates. The committee is based on a recommendation from the Institute of Medicine.There's no question that the agency needs to do a better job in this regard. The public has mistakenly come to understand that a product with FDA approval should have zero risk. This perception is part of why the agency has taken such heat over products that have proven too risky after approval.The question is whether the goal of clear, concise, consistent, and contextual communication can be achieved by a committee of 15 people. To quote the FDA release: "The advisory committee will be made up of 15 voting members that include experts and public members who are not affiliated with the FDA. Experts will include authorities knowledgeable in the fields of risk communication, social marketing, health literacy, cultural competency, journalism, bioethics, and other relevant behavioral and social sciences. Public members will include those who can provide the perspective of users of FDA-regulated products, such as consumers, patients, caregivers and health professionals."That's a lot of voices, all with different agendas. This has the potential to be "committee hell." I foresee a group of people that aren't going to be able to agree on anything, which wouldn't make FDA's message any less muddy than it is today. The idea is a good one, but a large and unwieldy committee will make execution difficult.
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