It seems that president elect Donald Trump wants an investor as the next FDA commissioner, as Dr. Scott Gottlieb, a partner at one of the world's largest venture capital funds, is also now rumored by Reuters to be on his short-list for the top job.
This will likely be a relief for some as last week Jim O’Neill, the managing director at Peter Thiel’s tech investment firm Mithril, was also said to be a candidate by Bloomberg news.
But while libertarian O’Neill has no scientific or research background (and believes the FDA could do with some major reform), Dr. Gottlieb was formerly the deputy commissioner of the FDA, and a more traditional candidate.
He’s now a venture partner at New Enterprise Associates but given his background, would fit more easily into what would be expected at the FDA. As with many within the FDA over the years, Dr. Gottlieb's ties to biopharma run deep, given that he sits on the boards of a number of co's, consulting with others, such as GlaxoSmithKline.
The current commissioner, Dr. Robert Califf, will soon resign from his post given that there will be a new president next month.
Trump can decide to accept his resignation, and thus choose his own candidate, or reject it, keeping Dr. Califf in position. However, this is appearing increasingly unlikely, given the names being bandied about have not yet included his own.
O’Neill appears to dovetail more with Trump’s picks across other departments, such as Scott Pruitt, who is line to run the EPA despite being a climate change denier, and is set if confirmed to cause a radical shake up of its philosophy.
This is the tone already being set by Trump’s upcoming presidency, a man who won the election promising major change across the country and its departments.
O’Neill has previously stated that he would like to see faster approvals based predominately on safety, with efficacy sorted out after drugs have been approved. This would go against the fundamental principles of the FDA, and it remains to be see just how that would be implemented under its current rules.
The Cures Act, however, which was voted in last week is already edging toward this, with a new package deisgned to help speed up approvals for new drugs and medical devices. Trump too has already said in a brief update this he wants to “reform the FDA,” although how and when has not been made public as yet.