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wo critics of the Food and Drug Administration met with President-elect Donald Trump Thursday to discuss running the agency.
Silicon Valley insiders Jim O’Neill and Balaji Srinivasan have both called for major agency overhauls.
O’Neill’s candidacy for FDA commissioner was divulged last month. O’Neill is a managing director at Mithril Capital Management and a protégé of billionaire Peter Thiel, a key Trump transition adviser who initially proposed O’Neill for the job.
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Srinivasan, however, is a new name in the mix. Srinivasan, like O’Neill, is an investor in numerous tech startups and has worked closely with Thiel. He is also a board partner in Andreessen Horowitz, the major venture capital firm.
Srinivasan is best known as a founder of the lavishly funded bitcoin startup 21 Inc. In the health care sector, his most notable venture is Counsyl, a company he co-founded which makes prenatal genetic tests. He is no longer involved in the operations of the company, but his prior role as chief technical officer may hurt him with anti-abortion groups. Among its other products, Counsyl offers a blood test that allows screening of a fetus as early as 10 weeks for Down syndrome.
Both O’Neill and Srinivasan have been highly critical of current drug approval practices at FDA.
High on O’Neill’s recommendations for the FDA has been his call to permit companies to market new drugs without first proving that they work. Srinivasan, for his part, has claimed the FDA creates “catastrophes” to increase its funding and that drug development takes too long.
“Drug development prior to FDA shows that modern regimen is not necessary for safe innovation,” he tweeted last month.
“A drug fails, and the producer’s market cap deservedly drops by millions. A drug fails, and Congress increases the FDA’s budget by millions,” he wrote in August.
“Before the FDA, scientists were able to take insulin from bench to bedside in two years,” he wrote, also in August.
Both O’Neill and Srinivasan are also vocal advocates of developing sea-based communities, or “seasteading.” O’Neill has suggested these could be used for medical tourism, far from government reach. In a 2013 talk, Srinivasan said that one way to move toward a better future is to “create peaceful ways to exit and start new countries,” including by seasteading.
The other leading candidate for a position within FDA is Scott Gottlieb, a former FDA deputy commissioner and resident fellow at the American Enterprise Institute. Gottlieb has strong bipartisan support, and is well-known to many in Congress. His chief vulnerability in confirmation hearings would likely be his own role in the venture capital world and his work with numerous drug companies.
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