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Trump Meets With Two US FDA Commissioner Candidates .pdf

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Trump Meets With Two US FDA
Commissioner Candidates; Third Still
12 Jan 2017

Derrick Gingery @dgingery derrick.gingery@informa.com

Executive Summary
O'Neill and Srinivasan head to Trump Tower, but Gottlieb has not been eliminated.
President-elect Donald Trump interviewed what appear to be two unconventional
candidates for FDA commissioner, but at least one other potential selection remains
among those that could receive the nomination.
The transition team indicated that Trump met with Jim O'Neill, managing director of
Mithril Capital Management, and Balaji Srinivasan, who is a founder of a direct-toconsumer genetic testing company, as well as a partner at Andreessen Horowitz and
CEO of 21.co, on Jan. 12 at Trump Tower in New York. Both have ties to Silicon
Valley billionaire Peter Thiel, who also was seen entering Trump Tower on that day,
according to press pool reports.
If O'Neill and Srinivasan are being considered for FDA commissioner, they would
represent a departure from the typical qualifications for the job, namely that the
commissioner be a physician.
O'Neill, who has held several positions at HHS in the past, already has been floated as
a potential commissioner candidate. Public statements indicate he prefers that FDA
allow marketing approval of products based only on their safety profile, without proof
of efficacy. (Also see "Possible Trump FDA Commish Candidate Favors (Much)
Lighter Touch" - Medtech Insight, 8 Dec, 2016.)

Srinivasan Has DTC Screening Ties
Srinivasan is a new name, but also is in the technology business. His LinkedIn profile
indicates he is "broadly interested in new technology, with a particular focus on 'real
world' applications where digital bits interface with physical atoms and substantive
problems, such as quantified self (health care), MOOCs/edtech (education), Bitcoin
(finance), drones, and 3D printing."
As CEO and cofounder of 21.co, a company funded by Andreessen Horowitz, Thiel
and others, he works on software and hardware for bitcoin micropayments, according
to the profile. He also teaches bitcoin engineering at Stanford University.
In addition, Srinivasan co-founded Counsyl, a DNA screening company, and has been
published in the New England Journal of Medicine, Nature Biotechnology and Nature
Reviews Genetics.
He received a PhD from Stanford in electrical engineering. The profile states his
research focused on genetic circuits, systems biology, microbial genomics and
interaction networks.
Like O'Neill, Srinivasan also seems interested in cutting back on FDA regulation.
Srinivasan could prove an interesting leader of FDA, especially for the device arena,
given his experience in genetic testing.
Silicon Valley stakeholders have pushed back hard against the agency's moves to
regulate DTC genetic testing. The most prominent debate addressed 23andMe's
offerings. That firm has come into alignment with FDA, and was granted its first
marketing authorization in 2015. (Also see "FDA, 23andMe Open Up Market
Pathway For DTC Genetics" - Medtech Insight, 20 Feb, 2015.)

Gottlieb Still In The Running
A source close to the transition said that Scott Gottlieb also remains in the mix for the
commissioner post, although he has yet to schedule a meeting with Trump.
Gottlieb, a physician, American Enterprise Institute fellow, well-known FDA and
health-care pundit and former FDA and CMS official, was named part of Trump's
HHS landing team in December.
He was thought to be a potential front-runner given his credentials, federal
government and frequent appearances at events with ideas for agency improvements.

(Also see "Gottlieb Joins HHS Transition Team; Will Next Stop Be FDA?" - Pink
Sheet, 1 Dec, 2016.)
That he remains a candidate should soothe the fears of some stakeholders, who worry
Trump's FDA pick could drastically alter agency policy and operations.
Concerns inside the agency about the upcoming change were serious enough that
Center for Drug Evaluation and Research Director Janet Woodcock produced a video
for staff suggesting they keep their heads down and focus on their work and mission
rather than the uncertainty associated with the presidential transition. (Also see
"Woodcock Tries To Calm US FDA Staff Fears About Trump" - Pink Sheet, 21 Dec,

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