Conflict of Interest Evidence Thread - C. Hinrichs in ODAC Meeting, page-4

https://www.fda.gov/media/87421/download

The FDA's own slide show at slide 8:

• 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.

The legislation required the FDA's pre-approval to serve in the Advisory Committee, otherwise that person CANNOT SERVE on the committee. This arguably means the FDA now has to nullify the Hinrich vote because it was invalid.