Former US FDA Commissioner is joining the health-technology firm Verily, a Google spin off. In a podcast interview he discusses his new advisory role with the company and expresses his hope that new FDA Commissioner Scott Gottlieb would stand up to any 'whimsical directives' from President Trump.
Former US FDA Commissioner Robert Califf is joining digital health and medical device company Verily Life Sciences LLC as an advisor, but his move to the corporate side of healthcare does not appear to have reduced his appetite for public policy pronouncements.
In an interview with the Pink Sheet's sister publication Medtech Insight, he spoke about the new position, and also discussed the new FDA Commissioner Scott Gottlieb. Califf says Gottlieb was clearly the most qualified candidate but hopes he will be ready to push back against any unreasonable demands from President Trump.
Califf's new job with Verily will allow him to maintain his professorship at Duke University while also joining Stanford University as an adjunct professor. He says he hopes to use the new position to help bridge the gap between technology and health-care services.
Listen to the entire interview via the podcast player below or click here
Podcast: Califf on Verily, Gottlieb, Trump
The news that Califf would be joining the company formerly known as Google Life Sciences was first reported by CNBC on May 16. The former FDA commissioner confirmed it in a blogpost on Verily's website.
"Although we are in the midst of an explosion of capability in the worlds of computing and information, we are still learning how to translate this capacity into better health and health care," Califf wrote. "Bridging this gap has been a recurring theme of my career, and it’s at the heart of what I hope to accomplish at [Verily and Duke]."
In our podcast interview, Califf says he'll be able to bring a strong regulatory background to the company.
"The amount of information that you ingest as FDA commissioner and the expert way in which you get briefings that inform you about entire areas of science and industry are just phenomenal. I'm hoping – Verily is involved in a lot of different things – as I help out I'm expecting that things that I learned along the way will be very helpful."
Verily is engaged in a broad range of projects and partnerships with device, drug and technology firms, including miniaturized continuous glucose monitors, surgical robotics, population health tools and precision medicine databases.
Califf is very optimistic about the progress made in the 21st Century Cures legislation and the user fee reauthorization bills that are moving through Congress for approval now. He says the medical products industries should pay particularly close attention to the inspection staff reorganization and review process changes FDA is currently undertaking.
While he already misses his colleagues at FDA, Califf says he's confident in Gottlieb.
"Scott is clearly the best candidate of the pool of candidates; he's well-prepared," said Califf. "He's worked with the FDA before, he's a doc so he understands the medical products side quite well, people like him at the FDA who worked with him before, and his experience the last few years in product selection, at GSK for example, has given him I would guess a lot of insight into the issues that come up in technology development and I think that will be important.
If the president makes any unreasonable demands of FDA, Califf says he hopes the new commissioner will take a stand.
"I hope that he'll be able to stand up if there are any whimsical directives from the president, which [could be] like a tweet in the middle of the night or something like that, who knows what might happen there," he said. "And I think if that happens he'll need to be strong."
Gottlieb pledged during his confirmation hearing to maintain FDA's scientific independence, even if faced with political pressure. (Also see "Gottlieb's Confirmation: He's Willing To Disagree With Trump, Sec. Price" - Pink Sheet, 5 Apr, 2017.)
And while Califf doesn't seem to think much of after-hours tweeting, he's no stranger to kicking up 140-character controversies. The day before the Verily news was announced, for example, Califf's tweets addressed several hot button issues. He argued that "we need a serious national discussion about regulation of dietary supplements" and that "opioids have valid medical use; but corp. boards making $$ need to take social responsibility to deal with downstream harms."
In the podcast interview, Califf also talked about the digital health industry in general, stating while he expects a majority of digital health companies to fail, he is also confident that a significant number of them will bring products to market that will change the health-care landscape.