Dear Colleagues --
Midday today the news wires lit up with the announcement that FDA Commissioner, Scott Gottlieb, will resign sometime next month. This comes out of the blue. I attach both his resignation letter, dated today, and a Washington Post article that provides good insight and background on his tenure as commissioner. You will note comments from Dr. Pieter Cohen with respect to dietary supplements.
Speaking of which, of interest to us will be the status of the two big issues announced by Commissioner Gottlieb, specifically, advancing a regulatory pathway toward CBD and an April public hearing to that end, and the announcement of FDA's intention to seek DSHEA amendments in Congress with a May public meeting to be scheduled.
We will keep you informed as we have a sense of where these two issues are going. Our current view is FDA's intentions on both issues are clear, and that the commissioner's decision to resign apparently was made several months ago, meaning his two major announcements were apparently made after he had decided to resign. Can we conclude that these two announcements are institutional views at the agency, and therefore they will proceed?
More to come.