The belief that the FDA is to undergo a major shift in thinking was given further credence as another curveball was thrown into the mix. Balaji Srinivasan, CEO of bitcoin startup 21.co, is now being considered for the agency’s top job.
Srinivasan, alongside tech capitalist Jim O'Neill, was said to have met with President-elect Donald Trump on Thursday afternoon.
Both “are being considered for positions in the FDA,” incoming White House press secretary Sean Spicer said on Thursday, as quoted by CNBC.
A month ago, Dr. Scott Gottlieb, a partner at one of the world's largest venture capital funds, was also rumored by Reuters to be on the short list for the top job at the FDA.
That news was likely a relief after O’Neill’s name first surfaced. O'Neill, who is also managing director at Peter Thiel’s tech investment firm Mithril (Thiel is also very close to Trump), was also said to be a candidate by Bloomberg news.
But while libertarian O’Neill has no scientific or research background (and believes the FDA could do with some major reform), Dr. Gottlieb was formerly the deputy commissioner of the FDA and a more traditional candidate.
There was no mention, however, of Dr. Gottlieb meeting with Trump yesterday. Srinivasan could prove a radical choice, or at least one far removed from commissioners of old.
Srinivasan is a vocal critic of the FDA, using Twitter a number of times to decry its work, saying recently: “big bad pharma does exist, but is only half the story. FDA sets the incentives.”
Another recent Tweet reads: “Why care about the FDA so much? Well, whether you want a new drug or to get to transhumanism they are the man to beat—or escape, via exit.” He also believes digital tech could trump the FDA in the regulation stakes.
The takeaway from these potential picks appears to be the desire from the incoming administration to lower regulatory barriers for new meds and med devices, with an inherent belief that the FDA is dampening innovation.
However, not all biopharma CEOs believe this, and this week Ionis CEO Stanley Crooke told FierceBiotech that the industry as a whole is suffering from low productivity and could be guilty of not being innovative enough.
Crooke believes this is one reason behind the need for many to bump up their drug prices; something Trump also this week said he would tackle in a brief update that could involve a “bidding process.”
Trump's comments, coming amid the annual J.P. Morgan biopharma investor event in San Francisco this week, sent biotech shares plummeting.
The FDA has been led by Dr. Robert Califf, but as a new administration comes in he must formally resign from his post.
Trump can decide to accept his resignation, and thus choose his own candidate, or reject it, keeping Dr. Califf in the position.