If President-elect Donald Trump is to “reform” the FDA as he's promised, he might start with an outsider pick to lead the agency. According to Bloomberg’s sources, the incoming administration is considering one far outside the usual box in tech capitalist Jim O’Neill.
O’Neill is an associate of steadfast Trump supporter Peter Thiel, the billionaire entrepreneur and venture capitalist who co-founded PayPal and invested early on in Facebook. O'Neill has no scientific background and little healthcare-related experience. He works as a managing director at Thiel’s tech investment firm Mithril and serves as a board member at Seasteading Institute, an organization seeking to create futuristic communities at sea.
The talks are not final and Trump’s team could select another candidate to head the FDA, Bloomberg’s sources said. How O’Neill would run the agency if appointed remains unclear, but the report that he’s being considered signals a major departure from conventions.
For one, in a 2014 speech, O’Neill advocated for the idea of “progressive approval.” He said that “we should reform FDA so it is approving drugs after their sponsors have demonstrated safety and let people start using them. … Let’s prove efficacy after they’ve been legalized.”
Needless to say, this would be a huge change from the FDA's current mission and the biopharma industry's research methods, which rely on clinical trials that test whether a treatment actually works. O'Neill said such a change would streamline the regulatory process and reduce development costs.
In response to that on Wednesday, Bloomberg Gadfly's Max Nisen tweeted that that quote alone should be "immediately disqualifying."
That one quote should be IMMEDIATELY disqualifying. https://t.co/MVnEcO7pGP— Max Nisen (@MaxNisen) December 7, 2016
O'Neill's only experience in health-related administration was a stint as a speechwriter and then policy adviser in the Department of Health and Human Services, according to his LinkedIn profile.
Trump’s transition site says the president-elect intends to “reform” the FDA “to put greater focus on the need of patients for new and innovative medical products.” His final pick would be subject to Senate hearings and a confirmation.
After his HHS positions, most recently as a principal associate deputy secretary, O'Neill was a managing director at Clarium Capital Management for nearly four years, according to LinkedIn. He's been at Mithril since June 2012.
Trump’s search for an FDA commissioner comes less than a year into the tenure of current FDA head Robert Califf, who was nominated after President Barack Obama’s former pick, Margaret Hamburg, resigned.
Califf is expected to soon turn in a letter of resignation, standard protocol during an administration change, but some backers say Trump should keep him around. Dr. Clyde Yancy, a former president of the American Heart Association, recently told Reuters that the agency was “evolving” under Califf. "We should allow that experiment to continue because the return on that investment could be enormous,” Yancy said.