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Shake up at the FDA: Califf is out as Trump eyes buddy of NJOY investor Peter Thiel

Posted by Matt Rowland on

In what could be a critical cabinet appointment for the U.S. vaping industry, rumor has it that Donald Trump is considering a former associate of PayPal founder and NJOY investor Peter Thiel to replace Robert Califf at the FDA. 

Jim O’Neill is the current managing director the Thiel-owned Mithril Capital Management and has publicly stated on several occasions his belief that the current FDA approval process for new drugs is far too laborious and complex.  This viewpoint is also a common complaint of the vaping industry regarding the newly announced FDA deeming regulations of last May that threaten to wipe out the entire industry by 2018.

Considered a staunch Libertarian, Jim O’Neill is not only allegedly pro-vaping, he is also said to be pro-cannabis, too.  O’Neill has served under the George W. Bush Administration as the Deputy Secretary for the Department of Health and Human Services.  Trump has already tapped Georgia Congressman Tom Price to fill this key cabinet slot, pending confirmation by Congress.

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When asked by Bloomberg news about a possible O’Neill appointment, Peter Thiel said that his associate “has extensive experience in government and in Silicon Valley. He is a strong candidate for any of several key positions”. 

Jim O’Neill and Peter Thiel: Pro-vaping advocates

Thiel was one of the early major investors in the e-cig company NJOY along with singer-songwriter Bruno Mars and Sean Parker of Napster fame.  NJOY made vaping history by filing and winning a lawsuit against the FDA in 2009, Sottera Inc. v. U.S. Food and Drug Administration.  The pioneering vaping company has since filed for bankruptcy protection.

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Many in the vaping community consider O’Neill’s strong ties to billionaire Peter Thiel as a positive sign that the FDA deeming regulations might be successfully repealed once Trump enters office on January 20.  O’Neill has publicly supported previous proposals to do away with the FDA’s current requirements for Phase 2 and 3 trials of new prescription medications. 

Vaping and its relationship with Robert Califf

While the current FDA administration headed by Robert Califf argues that delaying the approval process could possibly save lives by preventing patients from receiving drugs that are not proven to be 100% safe, O’Neill counters that delaying the approval process is perhaps even more deadly.  If patients are denied access to unapproved but likely effective medications, millions more lives could be lost.

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This is a similar stance long held by the U.S. vaping industry.  The current FDA deeming regulations under Califf’s guidance are based on the premise that vaping has not yet been proven to be 100% safer than smoking, even though several international public health organizations like the UK’s Royal College of Physicians say otherwise. 

If O’Neill applies his same logical reasoning strategies to e-cig regulations as he has for prescription medications approval, then the FDA deeming regulations might very well be repealed once and for all. While Jim O’Neill has not yet been officially selected by Donald Trump, and anything could happen, his appearance on the President-Elect’s short list as a possible Robert Califf replacement gives the U.S. vaping industry another small, collective glimmer of hope.

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