The Woman in Charge: Margaret Hamburg
Dr. Margaret A. Hamburg has served as the 21st commissioner of the U.S. Food and Drug Administration since May 2009. She graduated from Harvard Medical School and previously worked as the assistant secretary for policy and evaluation in the U.S. Department of Health and Human Services.
My interest in medicine evolved very early. I had two parents who were physicians, both professors at Stanford Medical School. I grew up right on the Stanford campus, and the parents of many of my friends were either physicians or scientists or in related fields. It looked like interesting and important work to me. When I started college, I began to realize that there were many other things I could do, but I always found myself coming back to medicine, and ultimately decided that was what I really wanted to do.
But I hadn’t really contemplated a career in public service until medical school, when I was very much influenced by the emergence of the AIDS epidemic. When I started medical school, nobody was aware of this new disease. In fact, when I was a freshman, I was taught that the era of infectious disease threats was over with the advent of antibiotics and vaccines and good sanitation practices–and that the future of medicine was chronic disease–and then watched this initially mysterious and devastating disease emerge, with no one knowing the cause, what to call it or how to treat it.
As I went on to do internal medicine training in NYC, I saw a lot of AIDS patients but I wasn’t able to offer them anything. I also saw how this medical disease was causing so much disruption in a variety of social, legal, and political issues. That’s when I decided I wanted to work at the intersection of medicine and social and public policy. I decided to go down to Washington and learn about health policy, and I have been engaged in some aspect or another of public health and health policy ever since.The Politic: Where do you think lies the line between the FDA doing its job to regulate and the FDA overstepping its boundaries?
This is a very interesting time to be in this kind of regulatory position. Certainly it is reasonable to ask questions about the appropriate role of government and the level of regulation needed to protect the health and well-being of the public, though sometimes the discussions can get surprisingly divisive.If you step back and look at the vital and unique work of the FDA—at all of the many, important products we regulate, and how much they matter to people–I think that there is a necessary and appropriate level of government regulation. Sound, smart regulation by the FDA not only promotes and protects the health and safety of the public, but it supports industry by ensuring clear standards and a level playing field, promoting meaningful innovation, and enhancing trust and confidence in the products it produces.
There is a constant need for balance in almost every aspect of our work, but there is an unmistakable benefit that comes from our responsibility to assure critical aspects of safety, efficacy, and quality of important products that people use and count on. Regardless of your political stripe, you want a certain level of oversight and certainty that you’re getting what you think you’re getting, and that it will help you and not hurt you.
There are different ways to approach our tasks under different circumstances. Oftentimes [the FDA] works with industry to encourage them to move in important directions, to identify the important goals that we can move toward, and to identify things they should do. But in some instances, it is important for us to assert our regulatory authority and simply take action.
For example, one area of concern is nutrition policy, and the question of whether we should be requiring industry to reduce sodium or trans fat in their products to address serious problems of public health. To be effective, we need to understand the concerns of industry, work with them towards reasonable goals, and set up reasonable timeframes for action. But if it’s in the interest of public health, we need to keep them moving in the right direction. Sometimes that will require mandating certain things.
The Politic: A lot of people have said that you’ve focused on tobacco products more than anything—you’ve sent over a thousand warning letters to tobacco product makers in 2011 alone. Why this focus on tobacco?
Tobacco is the leading cause of preventable disease and death in this country and around the world, so it has a very serious medical and public health toll. It’s a product that, through routine use, not only harms the individual who chooses to smoke, but potentially harms others as well. It’s an issue we have to take seriously from a public health perspective, and Congress passed legislation that the President signed into law in June 2009, which gave the FDA the authority to regulate tobacco products.
One of the clear areas of responsibility was to address the problems of marketing–since it is against the law to sell cigarettes to underage youth, part of our responsibility is to make sure that retailers understand that they should not be selling to young people, and to enforce the law when retailers continue to sell to them.
The Politic: How far do you see this regulation on tobacco products going? Do you ultimately see a ban on cigarettes in general?
The law was very explicit: it did not ban cigarettes. That might have been an option. Instead, they did ask us to look seriously at ways that we could achieve a couple of critical goals: to reduce smoking by young people, to encourage the cessation of smoking, and to try to reduce the harm of cigarettes and other tobacco products. We’re working on those different areas, and our goal is to find ways to better understand the underlying science of cigarettes in terms of what’s in these products and the damage that results. There may be ways to remove some of the harmful constituents and make the product less harmful to users. We are also trying to find ways to impact rates of smoking and to make sure that we are overseeing the appropriate manufacture and production of products [so as to not further compromise health by unsafe manufacturing practices].
So there’s a constellation of things that we are currently doing that will benefit health. We are striving to encourage cessation of smoking and encouraging young people not to start up smoking. And for those who need to smoke [cigarettes], we are trying to reduce the inherent health impact of those products as well.
The Politic: Let’s move on to the recent meningitis outbreak. Was the FDA in this case supposed to have prevented the outbreak, or was the role of the FDA more in the response portion?
Sadly, the current regulatory framework for these so-called compounding pharmacies is inadequate and ambiguous as to the state role and the federal role, and we need to address that concern. I hope we can work with Congress to craft new legislation that will strengthen and clarify existing law. Within the existing legal framework, we are in a much more reactive posture rather than a preventive one.
As a public health official and the head of the FDA, I would really like to be able to see a system that could help us prevent this type of tragedy going forward. As we’ve seen the industry and healthcare system evolve, I think what has always been a concern about a lack of clarity between state and federal responsibilities has gotten more pronounced and more dangerous. More and more health care systems are relying on sort of hybrid compounding pharmacy/manufacturer in order to produce products they need. These facilities are in a gray area in between state and FDA regulations. They’re not a drug manufacturer like Pfizer or GlaxoSmithKline, but they’re not a compounding pharmacy per se either. So we need new legislation that recognizes and responds the current state of the health care system and that addresses the fact that there are ambiguities in the law–for example, we currently have a circuit court [system] that causes different laws to apply differently in different states. That clearly doesn’t serve anyone well.
To my mind, this is really a critical moment for us to step up to the plate and recognize that we have a situation that does not serve the public well. We need to put in place the kind of regulatory framework, based in statute, that can enable us to do a better job for the American people.
The Politic: How big of a role does politics play in the work that you do?
I am very committed to running an agency where science and data drive our decision-making. But we are, of course, operating in a world where there are many issues and concerns swirling around us, and where the decisions we make have very significant ramifications. We work closely with many stakeholders, including Congress. It is always a challenge to make sure that the best possible science is the one guiding our work—but that is a challenge we must meet.
Policymaking is a complex process, and a lot of what we do involves addressing all kinds of issues that come into play. But at the end of the day, our regulatory decisions have to meet a certain scientific standard–that’s a great challenge, but it’s also the fundamental principle driving what we do.
The Politic: What’s your proudest achievement as FDA commissioner?
I think that I came onboard at a very interesting and important time for the FDA. I came at a time when there had been a lot of transition and turnovers, which created a certain amount of instability at the agency. It’s an agency that, for many years, has been under-resourced for the tasks that it is asked to do, as well as an agency that has both been buffeted about in the media and been target of criticism on the Hill and elsewhere. I came on board when there was a need to address morale issues and reaffirm the FDA in its unique and essential role.
I also came on at a time when there had been an explosion of science and technological advances that very much affected the work that we did and the products that we regulated; a time when there was a need to ensure that the FDA was scientifically positioned for the 21st century. I also came on at a time when the world had really transformed, requiring the FDA to become a global agency in both focus and in action, [since] a growing percentage of the products we regulate come–in whole or in part–from outside our borders.
So the answer to your question, albeit a long answer is: my greatest accomplishment has really been to reposition the FDA for the challenges of the 21st century and beyond. It has been an interesting challenge because it has involved institutional change in a way I hadn’t anticipated–but I think that it is making a very real difference.
The Politic: What do you think of Mayor Bloomberg’s ban on sodas in sizes bigger than 16 ounces?
I always get asked that question! You know, I think it was a very interesting position to take, and it triggered an important national conversation about food choices and the problem of obesity and nutrition-related illnesses. Do I think [the ban] will dramatically change the landscape of public health? I don’t, but I think that it’s one of many actions that speak to the fact that as a nation, we’ve kind of lost sight of moderation in what we eat and how we live. In the end, it certainly did trigger a conversation that’s helpful to have.
The Politic: What are you looking to regulate or focus on next?
Our authority to regulate is grounded in law, and we work within the law that Congress gives us. Of course, we have authority, within the legislative mandates that we receive, to pursue different activities in greater detail than others, and we work with Congress when we identify areas of new concern.
I am very eager to see legislation concerning the compounding pharmacy issues. I also really do think that this is an important moment for us to think and act in new ways around our global responsibilities. As I mentioned, we can no longer behave as a domestic agency, yet many of our laws were initially defined in the context of an agency that was regulating products made and used in the United States. In this transforming world, where we have seen the volume of imported products quadruple over the past decade, where 40% of finished drugs and 80% of pharmaceutical ingredients used in drugs come from other countries, where 50% of fresh produce and over 80% of seafood eaten in the US comes from other countries, we have to start really having a global presence. We have to now oversee some 300,000 facilities in 150+ countries bringing goods in through over 300 ports of entry. It’s a whole new landscape, and we have to rethink how we work from a legal regulatory perspective—with other countries and foreign regulatory authorities and industries—along with how we can stretch our already-limited work force to create this global footprint.
That’s an area where we need new thinking, new laws, and new partnerships to enable us to have this global safety net. This net will ultimately be vital in protecting the wellbeing of our citizens, and it will also benefit people around the world.