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Why Donald Trump's Putative FDA Pick Should Scare Pharma & Patients

Why Donald Trump's Putative FDA Pick Should Scare Pharma & Patients | Pharma Industry Regulation |

Yesterday, Bloomberg reported that Donald Trump is considering nominating venture capitalist and libertarian Jim O’Neill to head the Food and Drug Administration, and some in the pharmaceutical industry experienced an increasingly strong sense of nausea.

O’Neill, works at Mithral Capital, the firm founded by Paypal and Facebook backer Peter Thiel. That alone could normally serve to generate concerns about conflicts of interest with medical firms he helped to found. But O'Neill has also argued in the past that the lack of a functioning free market is the central fact that makes the current U.S. medical system overly expensive and wasteful. At a conference about creating new societies on ocean-rigged platforms, he argued that a better system would not involve government protections, that people should be able to pay others for organs used in transplants, and that the current system encourages bad health. “In a free market, you wouldn’t be forced to subsidize obesity,” he said in 2009.

But the quote that is causing the most unease is one about one of the FDA’s core missions: regulating drugs. In an August 2014 keynote at the Rejuvenation Biotechnology conference, O’Neill suggested: “We should reform FDA so there is approving drugs after their sponsors have demonstrated safety -- and let people start using them, at their own risk, but not much risk of safety. Let’s prove efficacy after they’ve been legalized.”

That quote betrays a lack of understanding of how drug approvals actually work, or a commitment to rolling back the clock 50 years.

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