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Executive Summary

Jim O'Neill, a Silicon Valley investment manager, would be an unusual choice to head US FDA, not just because he isn’t a physician, but because he’s favored substantially reducing FDA's role in assessing product effectiveness. While some experts are highly skeptical about O'Neill, who worked at HHS in the Bush administration, others suggest he could champion much-needed change at the agency.

 

US election_Pinksheet_Trump_FDA_Pharmaintelligence

 

A purported candidate to run FDA under the Trump administration would bring what some consider troubling views and experience to the commissioner post, but regulatory affairs stakeholders say Silicon Valley investor Jim O'Neill could be an interesting pick.

 

President-elect Donald Trump is reportedly considering replacing FDA Commissioner Robert Califf with O'Neill, an associate of the controversial Silicon Valley billionaire investor Peter Theil who backed Trump during his presidential bid.

 

Previous public statements by O'Neill suggest he favors a much reduced role for FDA. He has advocated reforming FDA so that products could go to market solely based on their safety profile and not require evidence of efficacy. In a 2014 speech, he said it should be up to patients to take the risks associated with an unproven drug and efficacy should be proven after product has been legalized.

 

The Trump transition team has not confirmed the report that O'Neill is under consideration. Another potential candidate whose name has been floated for the FDA commissioner post is Scott Gottlieb, a physician, American Enterprise Institute resident fellow, and former FDA and CMS official who recently joined Trump's transition team. (Also see "Will US FDA Wind Up With More Political Positions Under Trump?" - Pink Sheet, 4 Dec, 2016.)

 

Significantly, O'Neill is not a physician, typically considered a key qualification for an FDA chief. But he does have government experience. He began working at the US Department of Health and Human Services in December 2002, during the administration of George W. Bush, as a speech writer to the secretary on topics including the Medicare Modernization Act, Medicaid Reform, drug approvals and health information technology. In August 2005, he took on the role as an associate deputy secretary at HHS and served as a senior advisor to the deputy secretary.

 

 

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