Margaret Hamburg has been the Commissioner of the Food and Drug Administration (FDA) since 2009. In the below entry, part 2 of 2, Dr. Hamburg discusses her experience as Commissioner, her perspective on the FDA, and her advice for future FDA Commissioners. The interview was conducted by Ryan Hohman, Managing Director, Policy & Public Affairs of Friends in the Commissioner’s Office in White Oak, Maryland. As always, if there’s anything you’d like to add to the conversation, we invite comments, contributions, and engagement. Be part of the conversation and pitch your ideas for future contributors on Twitter @CancerResrch using #EngageInnovation or email us at firstname.lastname@example.org.
What has been your greatest challenge in working with the FDA?
What’s challenging about the FDA is that we do have this broad set of responsibilities and different commodities and categories of product are regulated in different ways with different legal frameworks and of course the science and technology that underlies the different products that we regulate is immense and growing rapidly, so keeping up with everything, understanding the different frameworks, understanding the scientific opportunities is a huge challenge. And on top of that, the world has become increasingly globalized and the products that we regulate no longer are essentially domestic in nature. We’re looking at supply chains that go all around the globe. We’re looking at some three hundred thousand different facilities around the world that are manufacturing products or components of products that are used by American consumers and under our jurisdiction. So it’s just an enormous set of responsibilities that every day get bigger and I have to say that in terms of delivering on what we are mandated to do, we do an awfully good job protecting and promoting the health and safety of American consumers and we’re a terrific bargain in terms of the budget that we’re given to do this important job.
What do you feel has been a major success of your FDA tenure that the general public might not be aware of?
I think that in everything that I’ve done as Commissioner, a huge focus has been on really repositioning FDA for the twenty-first century. We’re a very old organization—we were founded back in 1906—and actually many of our authorities are grounded in a very different era. But in the modern era, where science and technology is exploding in such important ways and where globalization is now having such an impact, FDA really was at a critical juncture in terms of making sure that we were equipped and responsive to the demands of the modern era. And also FDA really needed to step out. We are a regulatory agency and that creates a special set of requirements and expectations on our work and how we do it. But we can only be successful if we work in partnership with others and truly engage and listen to our stakeholders, learn from our stakeholders, and work with our stakeholders, and so we put a huge emphasis on greater transparency and strategies to partner as well. And I think all of this has really made us a stronger, better organization and I think has positioned us for the challenges of the future as well.
The FDA has to respond to the needs of massive industries, small businesses, advocacy groups, and individual consumers. How do you manage demands from such disparate groups?
Well it is challenging. This is an organization that is crucially important to a vast array of constituents and stakeholders. The decisions we make really do matter. They matter to the lives of individuals, the opportunities for healthcare, and certainly to major companies and our overall economy. So it’s a job where what you do and say is scrutinized, often criticized, and where any given decision usually makes someone unhappy, so you have to develop a thick skin for one thing. But I think the most important thing that I want to emphasize is the importance of using science as our compass for decision-making. Everything we do has to be grounded in science. We have to use data to drive our decision-making. I think as long as we do that, as long as we’re committed to using the best possible science and we’re committed to our mission to promote and protect the health of the American people, I think that we will be on track, we will continue to make a difference, and we will continue to find great gratification in the work that we do.
Is there any particular event or policy that you are proudest of in your FDA tenure?
Given the vast array of roles and responsibilities of FDA and all the things that we’ve been accomplishing, it’s hard to really focus in on one particular program, policy, or activity that I am most proud of. But certainly, I am proud of the people that work here at FDA who are so dedicated every day to fulfilling the mission of FDA. I’m really proud of what we’ve accomplished to really advance biomedical product innovation and I think we’ve made great strides forward to really work, importantly in partnership with the broader scientific community and with all of our stakeholders, from patient groups to industry, to really make sure that we are delivering as efficiently and effectively as possible on the opportunities that exist in science and technology today. And I’m very proud of the fact that we have stepped up to the plate in terms of seeing the future and what needs to be done and recognizing that we have to move beyond doing things in silos. We have to work across disciplines, we have to work across sectors, we have to work across borders because at the end of the day, science is a global enterprise. At the end of the day, the healthcare medical needs of patients are what has to drive us and I think we’ve seen just enormous benefit and progress made from working in partnership with so many others.
What was the best advice you got before you became Commissioner?
I think that one of the things that I was told that was wrong was: “Don’t think that you will really be able to measure that much impact. Don’t think that you’re going be able to take a big lumbering agency like the FDA and really make a lot of change. Pick a couple of initiatives that you can get done in a short period time and focus on those.” I think where I’ve made the most difference, actually, has been to really look at institution-building and look at this process of repositioning to make sure that FDA is adequately equipped for the challenges before us and for the future. And I think by really putting a new emphasis on openness and engagement, partnership and transparency, we’ve moved the ball in significant ways by really focusing on strengthening science within the FDA, but also our engagement with the biomedical research community and science more broadly. We’ve really made a difference and we’re better positioned to deliver on the promise of that science because of that and by recognizing that we live in a globalized world and we have to reach out beyond our borders and partner as well and really think about the science and the regulatory oversight as a global challenge. We’re making a difference that will endure.
What advice would you leave to future FDA Commissioners?
I think my best advice is: have a good sense of humor, be flexible and don’t take things personally, but keep your eye on the mission and remember that science has to be the compass that decides our decisions.