However we at FDA knew even prior to approval that this drug would kill people if released and that the labeling and plans to address it were nonexistant. Reviewers who raised concerns prior to the initial approval were removed from disccusions and backchannal discussions with Glaxo occurred then too.

With all due respect, the timing (alone — even without anything else) of her recusal, raises a fair question about cause and effect. It cannot be plausibly said that she was unaware that the letter was coming.

So, it is easy to infer a quid pro quo here: “recuse yourself, and we’ll indicate we find no conflict.” This sort of governing was an everyday occurence in the two Bush administrations.

And what of the choice to have a discussion with the press, BEFORE discussion with the involved companies (as a regulator charged with oversight)?

That seems strange — even in the most charitable soft candle-light I am able to muster.

So — on balance — I think these are fair questions. Please explain why any of the above is unfair, as a matter of inductive reasoning.

Namaste