Silicon Valley Figures May Play Role in New FDA

Jim O’Neill and Balaji Srinivasan, both of whom have made controversial statements on regulation, met with President-Elect Trump last week.

Current Food and Drug Administration Commissioner Robert Califf told the Washington Post in a December 29th interview that he had not had any contact with the incoming administration. “Here we are in a time when everything is digitized, we have scads of information, but as a society we haven't been so good at turning that information into knowledge, particularly in the medical arena,” he expressed in that exchange.

Still, Califf defended the FDA’s current mindset, believing the public to still desire that a drug’s effectiveness be proven: “Almost 90 percent of drugs that get into Phase One don't make it to market because of toxicity or they actually don’t work or they can’t be manufactured on a scale that’s needed…so that means if you are not demonstrating that a drug has a benefit, most of what they take won’t work.”

That organizational mindset may soon change fundamentally.

Fresh off of his own comments regarding pharma industry priceing practices that sent stocks running, Donald Trump met last week with two potential picks for FDA jobs, neither of whom is a stranger to unconventional suggestions for the industry.

Jim O’Neill and Balaji Srinivasan are two very different personalities with a common channel to Trump: both are connected to Peter Thiel, the Paypal billionaire playing a large role in the president-elect’s transition efforts. O’Neill has experience in the federal government’s health apparatus, as a former principal associate deputy secretary at the Department of Health and Human Services under George W. Bush. Currently, he’s an investor at Mithril Capital Management, the fund run by Thiel and Ajay Royan.

Srinivasan first rose to prominence by co-founding Counsyl with his brother and other graduate student colleagues at Stanford. The genome-sequencing company tests prospective parents for genes that may cause inherited diseases in offspring, and has serviced over a half-million patients to date. Since leaving the company, he’s worked for Andreessen Horowitz, the Silicon Valley investment firm, and launched a Bitcoin infrastructure company called 21, Inc., which Thiel has invested in.

The Hill, which initially reported the meetings, pointed to a string of tweets from Srinivasan criticizing the FDA’s status quo, seemingly favoring a more streamlined, technologically savvy approach to drug approval and availability. “Dallas Buyers Club was a good start, but it’ll take a Snowden-level event to change public opinion enough for Apple to stand up to the FDA,” he wrote shortly after the Apple Watch’s health-monitoring features were dropped to avoid requiring FDA oversight. Those tweets have since been deleted.

O’Neill has been far more vocal, and controversial, on the FDA’s role. He’s directly called for the organization to shift to only examining a drug’s safety, and not requiring efficacy to be proven, describing the organization’s current plight as “a miserable process.” “Every time the FDA commissioner approves something and someone gets sick who used it, the commissioner is summoned to a Congressional committee that also controls his budget and forced to testify under oath, why he made this rash decision,” he said in 2014.

Neither Srinivasan nor O’Neill has clinical experience, though O’Neill, who is rumored to be a potential choice to head the Administration, has aforementioned experience in HHS.