Scott Gottlieb Nominated for FDA Commissioner


First of all, this is not a political blog.  Second, I am certain that someone will still think it is.  Third, in this case, I do not care as I am an ex-FDAer that truly believes in the Agency and wants to see it succeed.  I was rooting for Scott’s nomination for many reasons, some of which are outlined below:

  1. I have worked with Scott from the industry side while he was at FDA as Deputy Commissioner and found him not only reasonable and thoughtful, but also a good listener. While he did not always agree with the position or the issues I was supporting, he gave it a true and honest hearing.
  2. I have been on panels with Scott and presented on the same stage with him. I find his points of view refreshing and thought-provoking; again, while we do not always agree, he makes his points with fact, humor, and at times, a bit of biting wit.
  3. He values the concept of both safety and efficacy in the drug product approval process. I have written about my views on this subject in several posts (including the one cited in Item 4 below) here , and here.
  4. He fits all the criteria I listed in my post “Who Is Going to Be the New Boss at FDA?” (here) that I feel are required for the job. Not that my views matter, but I have lived through a number of commissioners in my 40+ year career.

Now let us hope his nomination sails through the Congress, so he can get on with the business of using his talents to move the Agency forward.