Exclusive Interview: FDA Commissioner Talks Drug Pricing, Expanded Access, and Tobacco

Subscribe to the ASCO in Action Podcast through iTunes and Google Play. "Welcome to this ASCO In Action podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we take care of, people with cancer. My name is Clifford Hudis, and I am the CEO of ASCO as well as the host of the ASCO In Action podcast series. For today's podcast, I am delighted to have as my guest Dr. Scott Gottlieb, the commissioner of the United States Food and Drug Administration.

The FDA of course plays a critical role in the delivery of high quality cancer care by reviewing and approving cancer treatments. This continues to generate discussions about the pace of scientific advances, and indeed the regulatory role of the FDA. Given that, we are really lucky to be able to talk today with Dr. Gottlieb about the FDA's efforts to increase overall efficiency by updating or modernizing aspects of our clinical trials conduct and expediting the end to end drug development process.

I will admit that I'm going to take advantage of this opportunity to also ask how his agency is tackling the issue of tobacco control for the next generation of tobacco products, another area of deep concern from our community and others. Dr. Gottlieb, welcome and thank you for joining me today.

Thanks for having me here.

Great. Now as a professional society, we are very focused on the intersection of science and society. Given that, and noting that you've been at the FDA for more than a year following a long career in public service and in private industry, I have to start by asking, for you, has your current experience changed or evolved your view of the FDA's role or functions, and if so, how.

I've been at the agency three previous times. I had a good sense of what the agency's public health mandate was and what its mission was. I think that the nature of the market and the science that we're grappling with has certainly forced or compelled the agency's mandate to evolve. I think what we're seeing right now is, I feel like we're at the inflection point with respect to a lot of new opportunities from technology.

We look at things like gene therapy and cell-based regenerative medicine. Those fields largely didn't exist last time I was at the agency, and now we're an inflection point where we're going to see gene therapies approved to the market, and we saw three CAR-T's approved already, that are going to fundamentally transform the treatment of disease.

When I was last here, we were talking about the ability to advance genomically derived drugs and have more targeted approach to the treatment of patients where you can get the right drug to the right patient at the right time with sort of a drug diagnostic system, yet seeing some early examples of that. But now that is a much more routine development pathway.

With respect even to tobacco, you mentioned tobacco at the beginning, we're at a point right now where we have the opportunity to use new technology potentially to help currently addicted adult smokers transition away from combustible tobacco products onto products that we presume don't have all the same risks associated with them. And so using new authorities we have to regulate tobacco, including regulate nicotine levels in combustible cigarettes to render them minimally and not addictive, and allowing for a regulatory pathway that puts some of the new technologies like e-cigarettes through an appropriate series of regulatory gates, we have the opportunity to transition adult smokers off of combustible tobacco with all their morbidity and mortality associated with combustible tobacco use more rapidly than we did in the past. And so across the board, I think we're seeing technological inflection points. Digital health tools are another example that are not only creating significant new opportunities, but I think compelling the agency to rethink its t