The FDA’s brand-new commissioner Scott Gottlieb has been described as a “bright spot” inside current administration. He’s made allies in Big Pharma in addition to the technology sector by ushering along a variety of programs to reduce the cost in addition to complexity of bringing brand-new medical products to market.
Gottlieb is usually a former venture capitalist, a doctor in addition to a cancer survivor. Some of his major goals for his time in office are to speed up the approvals process, drive down the cost of prescription drugs in addition to do what he can to address the opiate crisis.
We caught up with Gottlieb earlier This kind of month to talk digital health, cybersecurity in addition to more. This kind of interview has been edited for brevity.
CNBC: Let’s jump in by talking about the digital medicine trend, which some view as the future of the health sector. How would certainly you regulate that will?
Scott Gottlieb: The industry has defined the term digital health in different ways. I think of that will as software applications, mostly digital tools in addition to medical apps. by a regulatory perspective, we are trying to take a risk-based approach. Some of these products are low risk in addition to we’ll think differently about them (than medical devices) in addition to take some out of pre-market review process. We see a lot of tools out there that will are enabling consumers to engage more with their wellness in addition to we want to give them access to their health information, without getting overly concerned if that will’s partially predictive (of a medical condition). that will’s what we’re trying to do with our pre-cert program.
CNBC: Speaking of the pre-cert program, which aims to provide a TSA pre-check of sorts for digital health software, some of the largest technology companies were selected for that will including Apple in addition to Samsung. How’s that will progressing?
SG: that will’s a highly iterative process. We know that will a lot of these apps will get constant software updates in addition to our traditional approach to regulating medical products isn’t well suited to that will. We know we need to think differently to ensure’s how we came up with This kind of approach. that will’s progressing well, in addition to we’re hoping to use that will as a broader platform for how we regulate. yet we’re taking our time to make sure that will works.
CNBC: How involved have you been in Apple’s heart study, which involves researching whether the Apple Watch can detect irregularities with the heart’s rhythm?
SG: I don’t want to talk about any specific product, yet I think that will in addition to similar concepts are examples of where a tool is usually engaging people in their health in addition to prompting them to think about activity more. that will could also clinically provide benefits if the companies follow certain guidelines. People who are engaged more in thinking about their health will make healthful decisions, I think. Just the act of being engaged is usually a public health benefit.
CNBC: Are you surprised that will big tech companies like Apple in addition to Alphabet are today doing such big moves into health?
SG: Frankly, I think health is usually such a big opportunity that will I’m surprised that will took them so long to take a concerted interest in that will. If you think about where people allocate resources in addition to tend to spend time thinking about getting access to information in addition to doing decisions in addition to purchasing consumer products to meet goals, that will’s a big market. I’m pleased to see the interest in addition to see a big, untapped opportunity for more consumer facing tools.