Pretty sure the Genzyme exec was David Meeker. I do not recall if the scenario was AA rules.
Also worth a note is Senator Rubio's speech from the Senate floor virtually assures Dr. Califf will be identified with this decision. A beautiful job of big picture maneuvering. (I suspect the O'Neill lobbying firm may have had a role.)
Drs. Bastings, Dunn, and Alexander were all part of Genzyme's multiple sclerosis drug Lemtrada Adcom emotional drama in 2013.
This sound familiar?
(Retrieved from Medscape). Voting "no," Caleb Alexander, MD, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, said, "If the clinical trials are not adequate or well controlled, I can't see how you can say there is adequate evidence of effectiveness." *
This etep decision is being played out way above Dr. Farkas. Dr. Woodcock has set up a policy battle for the future of the FDA. It's Dr. Califf's call to make.
*Reportedly infuriated, the Genzyme CEO dogged the FDA until it reversed itself and approved Lemtrada a year later.