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Hello and Thank you for joining me for Andy’s Take.
Each year the US Food and Drug Administration expends considerable resources convening over 60 advisory committee meetings. This is part of our commitment to engage a wide range of scientific expertise to inform our regulatory decision making process. This is the right thing to do for we must keep up-to-date with the rapidly-changing world of science related to the products we regulate.
My take on this is that something so important deserves careful scrutiny to assure we are doing it the right way. Our Advisory Committee function is therefore one of my highest priorities in our Agency wide process-improvement effort.
Assuring that we draw from an extensive and rich talent pool of advisors and manage appropriately concerns regarding conflict of interest are two aspects of such a process. Our current efforts are also addressing such issues as how meetings are conducted, including having an open and transparent process for convening and scheduling such meetings.
Many of you may not be aware of the great lengths we at the FDA go to to ensure the integrity of our advisory committees—to assure that we get good information and advice. FDA carefully scrutinizes each committee member for potential conflicts of interest—we review who they work for, any contract work they’ve done, and even any investments and stock they or their family members hold. We weigh the potential for those financial holdings to bias their participation with the need for their expertise and determine whether they should participate, and issue a waiver if appropriate. When a waiver is granted, we then share this information publicly so that others know what conflict might exist.
As consumers and patients we all benefit when diverse groups of world-class scientific and medical experts consult with FDA and provide us with the best possible advice about emerging technologies and difficult regulatory decisions.
Looking forward to you joining me for my next “Andy’s Take!”
For more information on FDA's Advisory Committees please visit:
http://www.fda.gov/oc/advisory/default.htm
Andy
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
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