The US Food and Drug Administration has announced changes to the way its advisory committees work in a bid to make the process for seeking advice from independent experts “as open, public, and transparent as possible”.
The FDA has issued a number of guidance documents and the one creating most interest refers to conflict of interest for panel members. The agency has now decided that if an individual, his/her spouse, or minor child has potentially conflicting financial interests totalling more than $50,000, he or she would not be allowed to participate in that meeting.
The guidance also specifies four scenarios where the conflict is significant and FDA does not intend to issue a waiver, even if the potential personal conflict is below $50,000. For example, the agency notes that if the advisor is the principal investigator of a clinical trial of a product about which a committee will be providing advice, the individual cannot participate in that meeting.
Also, before the FDA issues any waiver, “we will require a showing that the waiver is necessary to afford the committee essential expertise”, the agency states, noting that “we will limit the number of waivers we grant”.
It has also issued a final guidance on voting procedures at advisory committee meetings, saying that any question put to a vote must be “clearly and collectively understood by those voting”. The FDA adds that “a robust discussion of the issues at the heart of the question” needs to happen before voting takes place and recommends that votes be cast simultaneously rather than sequentially. This is intended to avoid ‘voting momentum,’ in which panel members “may be influenced, even subconsciously, by the votes of those who precede them”.
The FDA claims that this new set of rules makes its review of potential conflicts “more stringent than the legal requirements recently put in place by Congress”. It adds that these “new templates for waivers and financial interest disclosure will make them clearer and more consistent”.
