December 8, 2016
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Entrepreneur and Donald Trump supporter Peter Thiel has recommended Jim O’Neill, a longtime aide and investment partner, for a leadership position at the Department of Health and Human Services to helm the U.S. Food and Drug Administration in the Trump administration, according to news reports.
O’Neill currently serves as a managing director of Thiel’s Mithril Capital Management, Bloomberg reported this morning. He has had government experience, most recently serving as principal associate deputy secretary at the Department of Health and Human Services in the administration of President George W. Bush.
Although O’Neill has not been formally tapped for any role, he did land at the top of the FDA, Bloomberg said he would be the first in more than 50 years to head that agency without a scientific or medical background. If O’Neill was selected to helm the FDA, that could go along with plans Trump may have to disrupt the agency. While on the campaign Trail, Trump called the agency the “Food police,” regarding regulations placed on farmers and food inspections. But Trump has also called for more efficiency at the FDA when it comes to approving new drugs. In his 100 Day Plan, Trump said one FDA-specific reform he intends to undertake is to “cut the red tape at the FDA.” According to Trump’s plan, there are “over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.” Trump has also called for easing restrictions for drugs that have been approved by foreign regulatory agencies to be available in the United States, which would bypass the FDA’s regulatory authority over drugs available in the U.S.
O’Neill has also called for reforming the FDA. In a 2014 speech at Rejuvenation Biotechnology, O’Neill said the FDA should be reformed to allow for the approval of drugs “after their sponsors have demonstrated safety—and let people start using them, at their own risk, but not much risk of safety,” Bloomberg reported.
O’Neill also argued for a free-market approach to medication. In 2009, he said that kind of approach would drive drug prices lower and “allow innovation in cheaper delivery of care, both in terms of drugs and devices and better forms of delivery,” according to Bloomberg.
Not only has he argued for those kinds of reforms, O’Neill also condemned the FDA’s regulatory authority over companies like 23andMe. In the 2014 speech, Bloomberg said the FDA’s authority over that company’s proprietary algorithms that match genetic markers.
“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, according to Bloomberg. “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.”
If O’Neill is tapped for a role at HHS, he would serve under Obamacare opponent U.S. Rep. Tim Price, a Georgia Republican, who was selected as Trump’s choice for Secretary of Health and Human Services.
Trump takes office on Jan. 20. Neither the Trump camp nor O’Neill responded to Bloomberg or other news agencies for comment.