I am currently listening to an FDA stakeholder call on a new draft guidance for FDA advisory committee conflict of interest.
Rather than "in" or "out," the agency is suggesting three options:
(1) If an adcomm member has "some" conflicts, they can sit on the committee and participate in the meeting -- but cannot vote.
The FDA did not define what "some" means.
(2) If an adcomm member receives more than $50,000 compensation from a firm in front of an adcomm, they may not sit on the panal, participate in the debate, or vote.
It isn't clear (at least to me) in what period of time this money can be accrued (i.e., $50,000 in a calendar year, or in 12 months prior to the meeting, etc.).
(3) If a panel member has the "appearance" of a conflict they may be recused.
No definition of what "appearance" means. Perhaps this will be clarified in the actual draft guidance.
More as more develops.
Rather than "in" or "out," the agency is suggesting three options:
(1) If an adcomm member has "some" conflicts, they can sit on the committee and participate in the meeting -- but cannot vote.
The FDA did not define what "some" means.
(2) If an adcomm member receives more than $50,000 compensation from a firm in front of an adcomm, they may not sit on the panal, participate in the debate, or vote.
It isn't clear (at least to me) in what period of time this money can be accrued (i.e., $50,000 in a calendar year, or in 12 months prior to the meeting, etc.).
(3) If a panel member has the "appearance" of a conflict they may be recused.
No definition of what "appearance" means. Perhaps this will be clarified in the actual draft guidance.
More as more develops.
