Quite possible l@RhysD
https://www.fda.gov/media/87421/download
From the FDA's own take of its legislation, it certainly would have required pre-approval (upon being told of this conflict):
• If a particular matter will not have a “direct and predictable effect” on a SGE’s financial interests, the SGE, absent any “appearance” concerns*, can serve on the FDA Advisory Committee for that particular matter.
• If a particular matter will have a “direct and predictable effect” on a SGE’s financial interests, the SGE, absent the provisions outlined in 18 U.S.C. 208(b), cannot serve on the FDA Advisory Committee for that particular matter.
So the argument, post ODAC meeting now, might be stronger in that the vote should be nullified because a condition precedent to it being a valid vote has not been satisfied.
Quite possible...
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