Gee whiz, is this going to be enough to stop FDA from loading AAFCO with PFI members directly
dependent on the pet food industry? I've seen too many waivers already issued to think this
will change the nature of this dangerous advisory committee. In addition to advisor Michael Floyd,
where are your other independent advisors?
http://www.fda.gov:80/bbs/topics/NEWS/2008/NEW01871.htmlFDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
Two of the guidance documents address FDA's processes for evaluating and disclosing information about potential conflicts of interest and FDA waivers allowing participation in advisory committee meetings. Prior to each meeting, advisory committee members are screened by FDA staff to determine whether they have a potential financial conflict of interest, such as grants, stock holdings and contracts with a company that would be affected by the committee’s recommendations. Today, FDA is instituting a cap of $50,000 as the maximum personal financial interest an advisor may have in all companies that may be affected by a particular meeting. If an advisor’s personal financial interest is greater than $50,000, he or she will not be allowed to participate in that meeting. If less than $50,000, FDA officials may, in certain situations, grant a waiver, but will do so only if they determine that there is an essential need for the advisor’s particular expertise. Waivers, which include a description of the advisor’s personal financial interest and why the need for the expertise was essential, will all be posted on the FDA’s web site in advance of the meeting. FDA intends to use new templates for waivers and financial interest disclosure that will make them clearer and more consistent.
Another improvement addresses the public availability of briefing materials, the background information provided to advisory committee members in advance of a meeting. As detailed in the final guidance on advisory committee briefing materials, FDA intends to post briefing materials given to advisory committee members prior to a meeting on the FDA’s web site at least 48 hours before the meeting is scheduled to occur. The guidance document provides details on preparing and submitting documents to FDA for inclusion in the briefing materials, and also recommends a timetable that sponsors should follow when submitting such documents.
The agency also issued recommendations addressing the way that advisory committees will vote on questions, so as to avoid even the perception of any manipulation of votes. It is recommended that advisory committees use a process of simultaneous voting, in which all members vote at once. Previously, advisory committees sometimes voted sequentially, with the committee chair calling on each member individually and asking them to announce their vote aloud. Simultaneous voting avoids “voting momentum” in which some voters may be influenced, even subconsciously, by the votes of those who precede them. The agency also recommends that the results of votes be announced immediately in the meeting, and FDA intends to post on the FDA website a list indicating how each member voted. Any posted list will be part of the permanent record of the meeting.
