President-elect Donald Trump is considering Jim O’Neill for the position of Food and Drug Administration (FDA) commissioner. Mr. O’Neill is a staunch libertarian who has suggested eliminating the agency’s tradition of regulating new medicines regarding their efficacy before approving them to be put on the market.
“Let people start using them, at their own risk,” said O’Neill in a 2014 speech to a biotech group. O’Neill also suggested the practice of paying organ donors and setting up libertarian societies at sea. O’Neill also said he was” surprised to discover that FDA regulators actually enjoy science and like working to fight disease.”
Mr. O’Neill would be an unusual choice, since he doesn’t have a medical background. For the last five decades, the head of the FDA has either been a trained physician or a prominent scientific researcher.
Jim O’Neill’s Background
Jim O’Neill is a Silicon Valley investor and is close to billionaire Peter Thiel. O’Neill is a managing director at Thiel’s Mithril Capital Management. O’Neill is not well-known in Washington, but is a frequent speaker at biotech events, reports Scientific American.
Jim O’Neill graduated from Yale University, with a master’s degree from the University of Chicago. After a time as a speechwriter at the Department of Education under George W. Bush he went to work at the Department of Health and Human Services. He later became principal associate deputy secretary where he advised the HHS Secretary on policy, according to his LinkedIn page.
O’Neill later ran the Thiel Foundation and Breakout Labs, which funds early-stage companies in fields ranging from food science to biomedicine to clean energy. O’Neill is a promoter of anti-aging treatments and technology.
O’Neill is a board member of the Seasteading Institute, a Thiel-backed project to create new societies at sea away from existing governments, according to Bloomberg News. The Seasteading Institute is an organization whose goal it is to own sea-based floating communities, based on the theory that existing governments are ineffective. “Obsolete political systems conceived in previous centuries are ill-equipped to unleash the enormous opportunities in twenty-first century innovation,” notes the Seasteading website.
O’Neill has also said that organ donors should be permitted to be paid. “There are plenty of healthy spare kidneys walking around, unused,” O’Neill said in a speech at a 2009 Seasteading conference. In the same speech, O’Neill said, that “we can all wish that existing governments will somehow stumble into freedom, but if we want to achieve freedom, seasteads are by far the best prospect.”
O’Neill and the FDA
O’Neill is not well-known in Washington, but is a frequent speaker at biotech events, reports Scientific American. In an August 2014 conference called Rejuvenation Biotechnology, he referred to his time at HHS and expressed negativity regarding the FDA’s process. “As a libertarian, I was inclined to believe that the regulatory costs that the FDA impose kill a lot of people and provide a lot of harm to the economy, and I don’t deny that… but one thing that surprises me is that the actual human beings at the Food and Drug Administration like science; they like curing disease and they actually like approving drugs and devices and biologics.” The problem, according to what O’Neill told the gathering, is the overall structure and incentives of the regulatory system.
“Every time the FDA commissioner approves something and someone gets sick who used it, the commissioner is summoned to a congressional committee that also controls his budget and forced to testify under oath why he made this rash decision…It’s a miserable process,” O’Neill said.
O’Neill has suggested that the FDA only require companies to prove drugs are safe before they are sold, and not that they actually work, reports Scientific American.
An additional candidate for the FDA commissioner position is Dr. Scott Gottlieb. Dr. Gottlieb is a former FDA deputy commissioner. A resident fellow at the American Enterprise Institute, Gottlieb was a senior adviser to the presidential campaign of Wisconsin Governor Scott Walker. Gottlieb is a clinical assistant professor at the NYU School of Medicine, and is a venture partner at the venture capital firm New Enterprise Associates. He is also a senior principal at TR Winston, which is a healthcare focused merchant and investment bank. Gottlieb has testified 18 times before Congress on health and regulatory issues. Gottlieb was recently added to the transition team, according to Scientific American.
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