Trump Team Said to Consider Thiel Associate O’Neill for FDA

  • Jim O’Neill is a managing director at Thiel’s Mithril Capital
  • In speech, said FDA could approve drugs without efficacy data

Peter Thiel, co-founder of PayPal Inc., speaks during a news conference at the National Press Club in Washington on Oct. 31, 2016.

Photographer: Andrew Harrer/Bloomberg

President-elect Donald Trump’s transition team is considering a Silicon Valley investor close to billionaire Peter Thiel to head the Food and Drug Administration, according to people familiar with the matter.

Jim O’Neill, the Thiel associate, hasn’t been officially selected, according to the people, who asked to remain anonymous because the decision process is private, and the Trump team could still go in another direction.

O’Neill is a managing director at Thiel’s Mithril Capital Management, and last served in government during the George W. Bush administration as principal associate deputy secretary at the Department of Health and Human Services. He’s also a board member of the Seasteading Institute, a Thiel-backed venture to create new societies at sea, away from existing governments.

Thiel’s spokesman Jeremiah Hall said O’Neill is a good candidate. “Jim O’Neill has extensive experience in government and in Silicon Valley. He is a strong candidate for any of several key positions,” Hall said in an e-mail. Separately, Politico and CNBC reported that O’Neill could be under consideration for various positions.

Spokesmen for Trump didn’t respond to a request for comment. O’Neill also didn’t respond to requests for comment.

He would be an unconventional pick, since he doesn’t have a medical background. The head of the FDA for the last five decades has either been a trained physician or a prominent scientific researcher.

‘Reform FDA’

O’Neill also could push the agency in new directions. In a 2014 speech, he said he supported reforming FDA approval rules so that drugs could hit the market after they’ve been proven safe, but without any proof that they worked, something he called “progressive approval.”

“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,” O’Neill said in a speech at an August 2014 conference called Rejuvenation Biotechnology. “Let’s prove efficacy after they’ve been legalized.”

O’Neill has been a close associate of Thiel for nearly a decade. He first served as a managing director at Clarium Capital -- Thiel’s hedge fund that made a mint by correctly predicting the housing bubble and then crumbled -- and since 2012 has worked at Mithril Capital, Thiel’s late-stage venture firm, where he is a managing director. He also helped launch the Thiel Fellowship, which each year gives a small number of students $100,000 each to drop out of school and pursue entrepreneurial ideas.

Medical Tests

In the same 2014 speech, O’Neill said that when he was in the HHS he had opposed the FDA regulating some companies, such as 23andMe Inc., that perform complex laboratory-developed tests using mathematical algorithms.

“In order to regulate in this space, FDA had to argue that an algorithm, a series of numbers that match up to things, is a medical device,” he said. “I found that really astonishing -- astonishing that someone could say it with a straight face, and astonishing that someone could claim the ability to shut down companies that were never touching a patient but only accurately matching algorithms.”

At the same conference, he advocated anti-aging medicine, saying he believed it was scientifically possible to develop treatments that would reverse aging, though the drug industry’s approach to the idea was “long overdue for innovation.”

Broad Responsibilities

The FDA has some of the government’s broadest regulatory authority. Responsible for food, drugs, medical devices, dietary supplements, cosmetics and tobacco, it touches many aspects of what Americans consume. It’s also a key part of the pharmaceutical industry’s research efforts, responsible for overseeing clinical trials. In recent years, changes at the agency have been made to speed approval of new therapies in everything from cancer to hepatitis C.

In a talk at a 2009 conference, O’Neill touted the advantages of freer markets for a wide variety of health-care goods and services.

“Basically, because there’s not a free market in health care, people are suffering very significant health consequences that in a free market they would not suffer,” he said in a talk at the 2009 Seasteading Conference. Among other advantages, a free market in health care “would drive prices much lower and allow innovation in cheaper delivery of care, both in terms of drugs and devices and better forms of delivery,” he said.

Separately, Zenefits, the human resources startup, said its acting chief financial officer, Mark Woolway, will join Trump’s transition team. Woolway used to work for Thiel’s Clarium Capital and is another example of Thiel’s spreading influence.

“Mark will continue to serve as acting CFO at Zenefits while he helps out on the transition team,” said Jessica Hoffman, a spokeswoman at Zenefits.

Trump’s Plans

Trump himself has offered few specifics on what he wants the FDA to do. His transition website says the administration will “reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products” and advance research and development efforts in health care.

Trump also could go after drug prices. Time magazine published an interview Wednesday in which Trump, whose victory last month was greeted with a surge in pharmaceutical stocks, said he he’ll “bring down drug prices.” The Nasdaq Biotechnology Index dropped 2.9 percent at the New York close, after earlier falling 4.6 percent in the biggest intraday drop since June 24.

O’Neill did his undergraduate studies at Yale University, where he was a member of the concert band and played the horn, and has a masters degree from the University of Chicago, both in the humanities. He joined the Health and Human Services Department under Bush in 2002, first as a speechwriter, rising in the final years of the administration to head some policy functions, according to his resume on LinkedIn.

— With assistance by Eric Newcomer, and Lizette Chapman

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