Trump Is Considering Another Thiel Associate to Lead FDA

Updated on
  • Biotech exec may face anti-abortion dissent over fetal test
  • Srinivasan has called for ‘exit’ of tech community from U.S.

President-elect Donald Trump is considering former biotechnology industry executive Balaji Srinivasan to lead the Food and Drug Administration, according to people familiar with the matter, putting another candidate in the running who is aligned with venture capitalist Peter Thiel.

Srinivasan co-founded Counsyl Inc. and helped develop a pregnancy test to quickly detect Down syndrome and other severe, chromosome-related birth defects. That could put him at odds with Republicans, since such tests are used early in pregnancy to help couples make decisions about abortion.

Thiel, who’s advising Trump on science and technology in the new administration, is a libertarian who has advocated for disrupting society with technology in order to improve it. Srinivasan’s views about the U.S. government -- and the FDA in particular -- may create challenges in getting confirmed, if nominated. He’s called for letting Silicon Valley entrepreneurs secede from the U.S. and “build an opt-in society, ultimately outside the U.S., run by technology.”

Srinivasan was in Trump Tower in New York Thursday to meet with the president-elect’s team about leading the agency, said the people familiar with the matter, who asked not to be named because the talks were private. Srinivasan has pulled ahead of another Thiel associate, Jim O’Neill, for consideration to lead the FDA, according to one of the people. Scott Gottlieb, a former senior official at the FDA who’s now a resident fellow at the American Enterprise Institute, a conservative think tank, is also said to be in consideration.

Srinivasan and spokesmen for Trump didn’t respond to requests for comment.

Controversial Candidates

O’Neill, the first FDA candidate pushed by Thiel, proved controversial because of earlier comments suggesting that the FDA approve drugs based on safety data alone and let the market decide if they were effective. He has also advocated “seasteading” -- building separate societies at sea, outside the reach of government.

Srinivasan has engineering degrees from Stanford University and continues to lecture at the California institution. Counsyl launched in 2007, and its test is now used in about 4 percent of pregnancies in the U.S. each year. The testing company’s website says, “We help you make smart choices about your health, your family, and your future.” About 30 percent of fetuses with Down syndrome are aborted each year, according to a 2015 study in the American Journal of Medical Genetics.

“These tests must be ordered by a physician and are recognized by major medical societies,” Shivani Nazareth, Counsyl’s director of medical affairs said in an e-mail. “We support the right of patients and physicians to access this information and use it to make choices that are right for their personal circumstances.”

Srinivasan is no longer with the company, Counsyl said.

Not an FDA Fan

Trump has repeatedly expressed an anti-abortion stance, including plans to appoint a pro-life justice to the Supreme Court within two weeks of taking office. The Republican Party platform adopted before his election says that an “unborn child has a fundamental right to life which cannot be infringed.”

Srinivasan appears also not to be a huge fan of the agency he might run. In an August tweet, he said the FDA has slowed down the pace of scientific innovation.

“Before the FDA, scientists were able to take insulin from bench to bedside in two years,” he wrote. Last month, he bemoaned the agency’s move to curtail use of Scanadu’s Scout, an experimental device that detects heart rate and blood pressure.

“FDA bricks another device,” he tweeted on Dec. 18. “Part of their long war against new diagnostics.”

Then, in response to online criticism, he added: “You have to understand that much regulation is just safety theater. Has nothing to do w/ health.”

In his 2013 “Ultimate Exit” speech to the Y Combinator, a startup incubator, he touted a world run by software that could circumvent regulation, where it would be impossible to ban physical objects -- including medical devices. “You can 3D-print all these things,” he said, noting that there are “three-letter regulatory agencies” just devoted to banning goods.

Neither Srinivasan nor O’Neill has a significant medical background, and appointing either to head the FDA would be significant departure from tradition. For the past five decades, trained physicians or prominent scientific researchers have led the agency, widely considered to set the standard for ensuring the safety of medicines used to improve human health.

Tech Entrepreneur

Srinivasan is a proponent of personal responsibility and of the “quantified self,” a movement that uses technology to track different facets of an individual’s life and harness the resulting data to improve health and performance.

His record of founding and developing companies starts with Counsyl, which he says he helped dream up in a Stanford dorm room. He also founded and runs 21 Inc., a company backed by venture fund Andreessen Horowitz, Thiel and others, that allows users to earn bitcoin and create apps that use the alternative currency.

Along with Down syndrome, Counsyl says its Informed Pregnancy Screen can also be used to diagnose Edwards syndrome and Patau syndrome, rarer and more severe chromosomal defects that are often fatal in utero or the first year of life. The test can also determine a child’s gender and health issues that are linked to having too many or too few sex chromosomes.

— With assistance by Olga Kharif, and Drew Armstrong

(Adds Srinivasan’s comments on medical devices in the 13th and 14th paragraphs.)
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