Draft Guidance on Conflict of Interest for Advisory Committees Issued by FDA

The Food and Drug Administration today is scheduled to publish a Draft Guidance in the Federal Register entitled Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and DRug Administration Staff:  Public Availability of Advisory Committee Members’ Financial Interest Information and Waivers; Availability – The original draft guidance along these lines was issued in January, 2002.  The object, according to the Federal Register notice, is to "bring as much transparency as possible to FDA’s waiver process, and increase the consistency and clarity of the process." 

With that in mind, one must wonder why up till now, to get the waiver information, it has been announced at the beginning of advisory committee meetings that it would be necessary to file a Freedom of Information Act (FOIA) request rather than have it posted on-line for each meeting.   The FDA is now posting some conflicts of interest/waiver information on the Web page that contains information about meetings of FDA advisory committee meetings under the heading – Nature and Basis Statements of Conflict(s) of Interest

By way of background, members of advisory committees currently disclose their financial connections to industry and the FDA may grant waivers to those with perceived conflicts of interest if it is deemed in the best interests of the process to have the input of someone so conflicted at a meeting.  Waivers had been granted on a fairly routine basis. 

It is important to read this draft guidance in combination with one issued earlier this year called "Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees" to know when people will be disqualified, which replaced an earlier guidance in 2000.   

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