I will not speak to the specifics of the leak -- I will not give illegal and unethical behavior one inch of additional space -- nor will I spend any time or energy playing the "I wonder who the leaker is?"game. (Not that I don't have my own suspicions.)
What I do want to address is the growing trend within the FDA of "leaking" internal discussions to the media in order to try to force the agency's hand. If "politicizing" the agency is bad (and it is -- very much so) than it is bad writ large. The ends does not justify the means.
The FDA is an organization of health care professionals. An organization of many. Organizations have hierarchies. And organizations have rules. And rules are meant to be followed. The alternative is chaos -- a state into which the agency mustn't spin. When rogue employees choose to take the law into their own hands -- even when they believe their position is the correct one -- bad things ensue and stakeholder trust erodes. And, yes, one stakeholder is the pharmaceutical industry. Another is the American citizen.
Anonymous leaks are not the acts of whistleblowers -- they are the acts of cowards.
An "FDA of One" is one very bad idea.