Dr. Margaret Hamburg. Photo by FDA, accessed via Wikimedia Commons.
Dr. Margaret Hamburg
served as Commissioner of the US Food and Drug Administration (FDA) from 2009 until 2015. While at the FDA, she focused on its expanded role in a globalized world and improving its scientific research capacity, and she achieved great success in gaining FDA oversight and regulation of tobacco, among other things. After attending Harvard College and Harvard Medical School, she completed her medical residency, conducted research on neuroscience, and served as Commissioner of the New York City Department of Health. Alison W. Steinbach talked with Dr. Hamburg about her experiences prior to and at the FDA, the FDA’s expanded role in an increasingly globalized world, and global regulatory coordination for food and drug products.
What were your career paths and interests prior to serving as the FDA Commissioner?
I am a Harvard grad – undergraduate and medical school – and I planned to have a career in academic medicine – teaching, doing research, and taking care of patients. But as I watched the AIDS epidemic develop during medical school and my medical residency, I became interested in health policy. In the early days of the HIV/AIDS epidemic, medicine had little to offer, but the intersection of medical issues with broader social, legal, ethical, and political issues was huge. I decided I wanted to explore the intersection of all those areas, and after doing my residency training in internal medicine, I went to Washington to experience the world of health policy. My career then unfolded along a very different path, with a strong focus on public service and health policy.
I worked first at the National Institutes of Health on AIDS research and policy, and then became the Commissioner of the New York City Department of Health, which is probably the premier and the largest health department in the country, if not the world. I was first the acting and then became the official commissioner and served in that role for six years, three years under Mayor Dinkins and three years under Mayor Giuliani.
It was an extraordinary opportunity at a very early stage in my career. I had the chance to deal with a wide array of issues and had my first taste of what it is like to be a visible public servant in a significant but sometimes controversial role. I had the opportunity to work on critical issues in HIV/AIDS, which is what drew me into public policy in the first place. I also had to deal with a very serious resurgence of tuberculosis in a new, more dangerous drug-resistant form; we were able to put in place a program that turned around that epidemic far more quickly than we ever dreamed possible. I also had a chance to work on broader issues ranging from maternal and child health and school health to chronic disease.
Most strikingly for me during that period was the infectious disease arena and the recognition of how vulnerable society is to infectious disease threats. Threats of that sort are not just health threats, but also security threats in important ways. I could see that with the response to HIV/AIDS and tuberculosis, as well as with naturally occurring disease threats. I could see it in terms of the threat of imported disease – disease outbreaks that were occurring elsewhere and being brought into New York, or potentially into New York – and the emergence of new diseases that had not been a concern before in the city, being a hub of international travel, trading, and commerce.
I was health commissioner the first time the World Trade Center was bombed, and that woke me up to the reality of domestic terrorism. I began to think about my responsibilities as health commissioner for the city in terms of preparedness against an array of potential terrorist threats, including biological terrorism – the intentional use of a biological agent to do harm – and to my surprise, found myself increasingly moving into areas of work that involved the intersection of intelligence, law enforcement, and health. We thought about how to protect the citizens of New York against the deliberate use of biological organisms as well as against naturally occurring disease threats. Today, more than ever, these kinds of issues are appreciated in terms of their importance, but at the time, many of my colleagues in public health thought I had gone off the deep end. One of my mentors told me I should be dealing with real world issues, and another said I had been reading too many Tom Clancy novels. But as I transitioned from New York City to a role as Assistant Secretary for Planning and Evaluation in the Clinton administration, I continued to work on those issues and helped build a program at the Department of Health and Human Services to better prepare against both naturally occurring and deliberately caused biological threats – we crafted an influenza preparedness plan as well as a bioterrorism preparedness plan for the nation. Those were huge, ongoing interests before my time at the FDA.
When did you start at the FDA and what were your initial reactions or surprises?
I became FDA Commissioner in May of 2009, and stepped down in April of 2015. I served for almost six years, which is twice the average tenure in recent history for FDA Commissioners, and much longer than I had expected to stay. It was an incredible opportunity. It was not a job I had ever had my eye on; I had worked with the FDA some from the National Institutes of Health when I was doing AIDS research and policy, and then as health commissioner of New York City around some foodborne outbreaks and other drug contaminant issues, but I did not deeply understand what the FDA was and what it did. I knew that it would be an interesting, challenging role, and when I got there, the learning curve was incredibly steep. I discovered, much to my surprise, that my background was very appropriate for the FDA commissioner role because I had a strong grounding in public health and had also done basic science research – I spent a year at the National Institutes of Health before medical school doing neuroscience research and had done research during my medical residency training in New York at Rockefeller University in neuroscience as well (that was one of my strong academic areas of interest), and then later at the National Institute of Mental Health. I was interested in and had experience in the food safety and regulation side, the nutrition science side, and the biomedical research and medical product development side.
One of the amazing things to me about the FDA was the breadth and depth of its responsibilities – the scope is incredible in terms of overseeing the safety, efficacy, and quality of drugs, vaccines, medical devices, dietary supplements, tobacco, food, and cosmetics (in terms of safety). The FDA regulates about 80 percent of the food supply (the USDA regulates meat, poultry, and processed eggs, but the FDA does everything else). The FDA has responsibilities in the nutrition area as well, overseeing the nutrition facts panel on processed foods and issues around certain dietary recommendations.
The FDA is hugely important to public health and to all of our lives every single day, from toothpaste in the morning to the food you eat to the drugs you take and sunscreen you put on – just about everything somehow involves the FDA. Between twenty and twenty-five cents of every dollar that consumers spend on products are products regulated by the FDA. I had no idea when I started the magnitude of the job and the responsibilities, and it was very sobering but exciting to take on that leadership role. Also, increasingly, the products regulated by the FDA are made in part or in whole in other countries around the world. The FDA was once a domestic agency focused on regulating products made and distributed solely within the United States, but in the world today, the FDA has to have a global perspective and approach. When I came to the FDA, I had not expected to be working on that set of issues so intensively. I had very strong interests in global health coming into the FDA and had worked particularly on infectious disease issues globally, but it was not something I was expecting to continue at the FDA. I discovered that a global perspective had to be among my highest priorities, and I spent a lot of time and effort building capacity for the FDA around the world and building new linkages with other regulatory authorities, industries, and the science community, which is increasingly multinational as well, to try to create a new paradigm for global governance and regulatory issues in the modern era.
About globalization, at a speech in Beijing and later at the European Medicines Agency, you stated that one of the FDA’s priorities “involved the growing challenge of globalization” which “has multiplied the scale of our responsibility and heightened the need for us to work together to ensure safety, efficacy, and quality of medical products, and to promote research and innovation in medical science.” In what ways do you think the FDA’s role has expanded or changed in recent years with increased globalization?
I think that the FDA no longer thinks that it can do its job in isolation. Certainly, it is a domestic agency with a charge to protect the health and safety of the American public, but in order to fulfill that role, the FDA has to work in new partnerships with other countries and in full partnership with a range of international stakeholders. Fundamentally, the way that the FDA thinks about its job has changed, and that it will increasingly be working in close collaboration with counterpart regulatory authorities and international entities in order to fulfill our mission. Part of what the FDA critically needs to do now is to help strengthen regulatory capacity around the world. That is both essential to the FDA’s job to protect the American public and also hugely beneficial to countries and regions around the world. Going forward, I would like to see more coordination between the work of the FDA and the regulatory mission with efforts to strengthen health systems around the world and efforts to invest in human and economic development of countries around the world.
What do you think was especially challenging working at the FDA, or what were the biggest challenges you faced? And what do you think your biggest accomplishment was?
I think one of the problems is that the FDA is an underappreciated agency; many think of it as just a big, bureaucratic black box, and especially in an era where there is a lot of anti-government and anti-regulation sentiment, there is a tendency to want to diminish the FDA’s importance and role. But in fact, it touches the lives of every American, every day, in fundamental ways that really matter to health and safety. Its impact of course goes well beyond our borders, and it is unique and essential to health and the quality of life in our country, yet for years, the FDA has been under-resourced and unable to fully fulfill its critical and essential mission.
When I took on the role as the FDA commissioner, it was a period of demoralization, as the agency was out of a number of crises. One of the first tasks I had was beginning to try to reenergize the FDA, to restore in some ways the FDA’s public reputation, and to enhance the trust and confidence in the FDA as a critical governmental agency. We tried to explain to the public and policy makers what we did, how we did it, and why, to enhance understanding of what we did. I was committed to trying to enhance the resources and support for our mission as well. I am very proud of the fact that every year while I was commissioner, the FDA in fact got a budget increase, and we also got new responsibilities, which I think reflected a growing confidence in our abilities. One example was tobacco legislation, as well as the passage of the Food Safety Modernization Act.
Former US Secretary of Health and Human Services Kathleen Sebelius and Dr. Hamburg announce new tobacco legislation in 2011. Photo by HHSgov, accessed via Wikimedia Commons.
The act gave the FDA new authorities to support food safety and to modernize the approach so that it was based on a preventative model rather than a reactive model. The goal was to understand where vulnerabilities in the food chain that leads from farm to fork, so to speak, exist, and how to shore up those vulnerabilities to prevent problems from happening, rather than waiting until problems occurred and then responding as quickly as possible. The Food Safety Modernization Act also recognized the global nature of the food supply and gave us new responsibilities and authorities to work on an international scale. The FDA also gained new responsibilities in the drug and medical device arenas as well, including a new focus on the global supply chains and global engagement.
All of those things were very important and reflected the growing strength of the FDA and respect for the FDA as an agency, and also helped to give us the tools and authorities we needed to do our job in the twenty-first century. I also felt it was very important to continue to strengthen and extend the FDA’s scientific capacities, because one of the great challenges is how to ensure the agency that is regulating and overseeing products that reflect advances in science and technology has the scientific capability to actually do that. It is hard to have all of the expertise you need in-house for the full array of products that the FDA regulates, but essential to either have those experts or have access to those experts so that we could support innovation in the marketplace and ensure that the highest quality products were being developed and made available to the people who needed them, and also to make sure that we were as efficient as possible in the work that we did. We worked on engaging with the broader scientific community to strengthen science within the FDA and capacity beyond, and also on focusing in on the fact that in order to be as effective as a regulator as possible, and to support the most efficient and modern medical product development systems and advanced food safety systems, there needed to be new investments in critical areas of science that were not being adequately invested in. How do you use data more efficiently in bringing IT capabilities and modern data systems to bear? How do you do clinical research more efficiently with new clinical trial designs that allow you to use fewer patients and shorter time frames to get the answers you need? How do you identify, early in the drug development process, which drugs are not going to work so you do not invest unnecessary time and effort and money developing them? We worked on systems to recognize potential toxic side effects or other problems early, and a whole array of areas of science that I call regulatory science. We worked on creating a new arena of the broader scientific enterprise of regulatory science, which I think has been important and is contributing to the FDA’s ability now to harness the advances in science and technology so that it can move as swiftly as possible from the discovery into a real-world product that will make a difference for people.
Research in the toxicology department of the FDA. Photo by Michael J. Ermarth, accessed via Wikimedia Commons.
Another critical priority while at the FDA was responding to the challenges of globalization and making sure that we could oversee products that were being developed in countries all around the world, and in many countries that have much less sophisticated regulatory oversight systems than the United States. Helping to build regulatory capacity in developing economies became a priority for me as well. I saw that as a matter that was critical to the ability of the FDA to do its job, but also critical more broadly to our interests in economic and human development and improving the security of our nation and other nations. Strengthening emerging industries in developing countries by better ensuring the quality of their products ultimately better ensures that products coming from other countries will meet the kinds of standards that we expect. This benefits those countries and benefits our country; I felt it was a win-win-win.
How much of your time at FDA would you say was devoted to international matters?
It is hard to say, but a very big proportion of my time, because it was such an important aspect of what we did. I was startled when I first learned the numbers: about 40 percent of finished drugs were coming from other countries, about 80 percent of the active pharmaceutical ingredients in drugs (the components that matter for the drug’s effectiveness) were being manufactured outside of our borders, about 50 percent of medical devices were being made elsewhere, about 50 percent of fresh fruit and produce were coming from other countries, and about 85 percent of seafood was coming from outside US borders. So in order to do our job to protect the American public, we absolutely had to engage on an international basis.
Could you talk more about regulation and about coordinating with global regulatory authorities?
One of the projects that was very gratifying to me was working with other regulatory authorities to help them build capacity. That was a challenge for the FDA because it was already stretched thin and is not a development agency. To provide ongoing technical assistance in the ways needed was an additional task, but very important as regulatory authorities in other countries were shaping their programs and systems. Being able to help them learn from our experiences to better understand what works, what does not work, and why, was very gratifying, and ultimately beneficial to the US FDA. I worked hard to help initiate an effort to build a new global governance mechanism for regulatory authorities around the world: a system to recognize the new requirements of a globalized world and the fact that all regulatory authorities are interdependent because products are moving between countries and being manufactured in whole or in part in other countries. The only way that any of us could do our job properly was to work together to share information, to share workload in terms of inspections and assessments, to look at science in a coordinated way as well, because science of course is now a global enterprise, and to assess new technologies and products to be able to work together and bring the best minds to bear wherever they are around the world.
My hope is that the effort to create this new global governance mechanism will continue to evolve, strengthen, and become an important institution going forward. I think that the United States has been and remains the global standard for food and medical product regulation around the world. Our influence is substantial and the opportunity to make a difference very real. I tried to work in a way that reflected the fact that there were many ways to approach problems and that every country and region had to adapt regulatory approaches for their own needs, but that the US FDA had a lot to offer and was very privileged (even though we were stretched for resources, we had so much more than most regulatory authorities). The opportunity to make a difference and to share our wealth of knowledge and experience was very gratifying.
How does the FDA coordinate regulatory efforts? Are there officials who are responsible for oversight?
It is hard – this global presence adds a huge additional set of challenges and expenses to the work of the FDA, but it is absolutely essential. The FDA now has offices in many regions of the world, but not in every country. The offices can have only limited impacts, but they become hubs, both for coordination with national or regional authorities as well as with industry and other stakeholders in terms of understanding the regulatory requirements and being able to provide technical assistance. The FDA also sends inspectors and experts from the US to different parts of the world to do inspections and to participate in meetings, workshops, and training sessions. Also, with various kinds of audio-visual technologies that exist, the opportunities for ongoing coordination and communication without having to travel overseas has been important. We have worked through many different kinds of mechanisms, including bilateral and multilateral agreements with other regulatory authorities, international organizations including the World Health Organization, and with counterpart regulatory authorities to get the World Health Organization recently to adopt a resolution focused on building regulatory capacity around the world. We also worked with other kinds of international entities as well as the new global governance mechanism.
It was a huge priority for me while at the FDA. We underwent a period of pretty dramatic expansion in our global footprint and leadership and I think it was a critical time for the FDA to think and act in new ways in terms of the global challenges. The volume of imports was increasing dramatically, but the FDA activities were remaining rather flat, and the disconnect was increasing. I think we turned that around and the FDA will never be the same – it is now a global agency. It is important in terms of the day-to-day activity and the ability for the FDA to actually do its domestic job, which is to ensure the safety, quality, and effectiveness of products that are being used by Americans, wherever they come from. But you also see the importance when there is an international crisis, like with Ebola, where the FDA played a critical role in helping to make new technologies available during the crisis in terms of diagnostics, vaccines, and drugs, and to continue to do research on safety and efficacy while the epidemic was still unfolding. And also to address an important concern that is often unrecognized about medical fraud, be it Ebola or pandemic flu or SARS or other routine conditions, there are a lot of fraudulent products that the FDA needs to monitor for counterfeit drugs and false claims about products. The FDA plays a very critical role in overseeing that and protecting the American public from taking products that are not what they claim to be, will not provide the benefits that they claim to provide, and often prevent people from actually getting access to the products and medical care that could help them.
What happens when the FDA disagrees with the regulations of other nations or about a certain drug, such as whether a drug is effective or whether research methods were proper?
In terms of regulatory disagreement, every country has its own national laws concerning regulation of products, and that shapes important aspects of product review and approval. Different countries have different burdens of disease, and that also affects the review and approval of a product. Countries can have different risk-benefit analyses: when there is very little disease and big risks, that probably is not going to be a good drug for that country, but when it is the reverse, a different decision might be made. For example, there was a fairly famous episode with a vaccine for something called rotavirus, which in this country is not all that prevalent. The vaccine turned out to carry with it a risk of intussusception, which is when the intestine turns on itself, and that can cause very serious problems which require surgical intervention and can cause death. In the US, with the low background rate of rotavirus, that complication was seen as an unacceptable risk. But in Africa, where rotavirus is very common and a major killer of young children from diarrheal disease, the risk-benefit calculation is different. That is just one example of why countries might come to different conclusions about the appropriate use of a product and approval.
Sometimes the assessments of the science is just are different as well. The FDA and other regulatory authorities increasingly work closely to review new products and to share assessments of data, risks, and benefits. The FDA is unique amongst regulatory authorities around the world in that we require reviews of the original data at the patient level, which provide insights that can be missed if you are only looking at the analysis of clinical studies as opposed to the underlying data. I think that the FDA does an extraordinary job at assessing the science for safety and efficacy and quality, and again, is the gold standard for the world. But there certainly are times when the assessments of a product do differ either because of the assessment of risk and benefit or sometimes a different analysis of the data.
In a globalized world where science is a global enterprise, the importance of finding ways of working together to share analytics and understandings about the benefits and the risks of these products is an important endeavor. More and more collaboration across regulatory authorities will be occurring, and efforts to harmonize approaches are increasingly important to ensure the best scientific analysis, the most efficient and scientifically-appropriate review and approval processes, and to make the process more efficient for industry as well so that overall, products will move to patients as quickly as possible and with the lowest cost possible.
Food and Drug Administration logo. Photo by FDA, accessed by Wikimedia Commons.
How do the FDA and the international community prevent fraudulent or counterfeit products produced by rogue nations or rogue organizations from harming US citizens?
This is really important, and the complexities of supply chains demand more attention and resources committed to this area for a lot of reasons. There is a continuum of concerns in terms of fraudulent or counterfeit products. There is the most extreme end of the continuum, which is the deliberate adulteration of a product to do harm, and on both the food safety and the drug side, that is a very real concern that we have seen happen. Also, there is the realm of economic adulteration – adulterating products so that they are cheaper but they do harm. For example, there is the famous case of heparin adulteration in China, which occurred before I got to the FDA. The product heparin is a blood thinner that is pretty commonly used in hospitals, and a critical ingredient in it comes from pigs (pig intestine actually), and most of that product was coming from China. There was an outbreak of a disease in the swine population called blue ear disease, and the pigs were dying off, causing an increase in the cost of pigs in China. There was a very clever adulteration that occurred: instead of using the appropriate product, there was a substitution of a chemical that on initial screening of the chemical composition, looked like the real heparin product. The standard tools for assessing quality did not reveal the adulteration, but it was discovered when people using heparin started to have unexpected immunologic toxic reactions and there were deaths. The FDA was able to figure out that there had been this adulteration of the product and fix it, and they have ongoing systems now for monitoring against it. But that was a very serious episode.
Similarly, there was an episode on the food side where something called melamine was added to dairy products to replace protein, but melamine proved toxic both to animals (it was in dog food) and to humans. Luckily, the US was not as hard-hit as it might have been because, almost by chance, there is a law that prohibits the importation of infant formula in the US. Many infants in China died or were hospitalized from this melamine-contaminated infant formula. It was found in some other products, including that White Rabbit candy, so my children were very upset when I told them “no more White Rabbit.”
There is economic adulteration, and then there is of course the threat of terrorism. I worried about that a lot in terms of food supply chains, and there have been many scares. There has never been the kind of deliberate contamination of the food supply that certainly is possible and that we need to be on the alert for, but you could imagine deliberate adulteration of medical products as well.
There is also the problem of counterfeit drugs, which is very serious and in fact increasingly part of the world scene, run, unfortunately often, by major crime organizations. One can in fact make more profit from counterfeit medical products than from the trade of illicit drugs, and penalties for counterfeiting drugs historically have been much less than even counterfeiting a Gucci handbag. We got legislation passed while I was the FDA commissioner that tightened the penalties for counterfeiting drugs, but it remains a problem, in this country, to some degree, but the FDA does a very good job monitoring, preventing, and intervening. But around the world, it is a huge problem. On top of counterfeit drugs, there is the problem of substandard drugs, where the quality is inadequate. It may not be intentional, deliberate fraud or true counterfeiting, but the result is that people are harmed because the drug does not do what it says it will do; the substandard product may expose them to toxins or have other contaminants such as glass shards.
Additionally, substandard antibiotics, which are quite common in Asia and Africa, can actually lead to the development of drug resistance, which is a huge public health problem because not providing adequate drugs to treat the infection it allows the resistant organisms to thrive, breeding drug resistance. In Southeast Asia and parts of Sub-Saharan Africa, between 30 and 50 percent of malaria medications are estimated to be substandard, leading not just to inadequate treatment for people with malaria, but breeding drug resistant malaria, which is a growing problem for the future. Ultimately, this threatens our country as well, due to the importation of drug-resistant disease and the fact that US citizens travel around the world and are exposed. Malaria is one prime example, but it is true for other resistant organisms as well.
Moving on to talk about international cooperation. Do you have any examples of when international cooperation or coordination was essential in tackling a global health issue?
International cooperation has certainly been very important in identifying a problem in the supply chain and preventing additional populations from being exposed to a dangerous drug because of contamination, counterfeiting, or other kinds of adulteration. In addition, in response to emerging threats like Ebola, the ability to work with other regulatory authorities is absolutely crucial. In fact, in West Africa, where there was not a very strong regulatory or clinical research capacity, the ability to help create the systems to assess products for local use in the midst of that crisis was extremely important and I think made a difference. On a more routine basis, the ability to work together around the globe really matters, be it monitoring global patterns of flu so that we make the right vaccine to best protect against the strain that will predominate during flu season, or the ability to quickly track a foodborne outbreak. For example, increasingly, the food supply has these complex supply chains so that components, packaging, and distribution are coming from different countries so a product that is eaten here may have components that are coming from many other countries. The ability to share information about what is happening and to apply new scientific technologies, like genomic screening of products to see whether the organism that is causing disease here is actually the same organism as something found in another country, is very important. Sharing all that information enables a much more rapid response to a problem and the ability to cut off the supply at the source so that the problem can be stopped.
On the flip side, where do you think international cooperation fell short, or where would you have liked to see more?
I think it is still very hard to always share information and collaborate in the ways that we would like to see because of the differences in national laws. We are not always allowed to share critical information because of limitations of law and confidentiality protections. That is an area that we need to continue to work on. I think issues of trust between nations still can get in the way. Often health issues can override conflict between nations to enable working together in new ways, but sometimes those conflicts can interfere with the response to a shared problem. We have seen that in response to pandemic flu and a reluctance to share samples. We have seen it in response to other kinds of problems, when there is a suspicion of whether, for example, vaccines are helpful or harmful. This is not specifically an FDA issue, but unfortunately in some parts of the world, there is a growing suspicion about immunization campaigns and whether they are actually intended to create other negative problems for the individuals who receive that vaccine, and a suspiciousness about the quality of vaccines. We see that in this country too: a lot of misinformation about safety and efficacy of a product. On the international scale – this is a bit off topic – one of the ways that information was gained about Bin Laden was through collecting tissue as part of a vaccine program. It was a use of a vaccination program for intelligence-collecting purposes, and in some areas, that has created a lot of paranoia about vaccination campaigns. We have seen vaccinators be threatened, even killed, just doing their job. During Ebola, there were threats to health workers as well because of the distrust of health systems and health products. That is a little off topic, but it is an interesting challenge.
You mentioned political conflicts and relationships. Do you think in the realm of health and science we cooperate better with nations? Do you think the FDA has a closer relationship with some countries than the State Department might?
I think often, the scientist-to-scientist relationship can lead the way in terms of strengthening relationships between nations. Again, this is not the FDA, but going back to the Cold War, the first breakdown in the barriers between nations came from scientist-to-scientist collaborations, and then other political actions started to take place. I do think that because of the shared concerns and the shared benefits in terms of public health, that often, health agencies can lead. The FDA had very strong working relationships in critical parts of the world that I believe benefitted the overall relationships of our countries.
On a different topic, if the Transatlantic Trade and Investment Partnership were passed, what kind of influence do you think it would have on food and medicine trade and global health?
That is a complex issue, but I think that in many ways, it gives us an opportunity to raise standards for everyone and to ensure more consistency in product quality and safety. We worked hard with the US Trade Representative office to make sure that the critical role of the FDA in terms of scientific expertise and decision-making would drive decision-making. We ensured that a trade agreement would not replace the FDA’s authorities and role working with our colleagues and regulatory authorities around the world, but that it would provide an opportunity to better align what we were seeking to achieve in terms of raising standards and consistency of approaches with the objectives of the trade agreement.
Justice Breyer has written a recent book about what the US can learn from courts around the world and different legal systems. How do you think the US and the FDA can learn from different regulatory, research, or health programs around the world?
I do think that there is a lot to learn from other countries and approaches. The FDA has one of the oldest and most well established regulatory approaches – we are now more than one hundred years old – but I think it is critically important to keep reexamining how we and other places do things so that we can change as needed. Other countries have looked at and thought about problems differently and developed systems that the FDA can benefit from. For example, the European Medicines Agency can teach a lot about how regulatory authorities from different countries can work together to create a more harmonized, unified approach. I think that is something that we need to figure out how to do better with not just Europe, but with countries all around the world. I think there is much to be learned organizationally and from a systems point-of-view. Many countries in the world now are on the cutting edge of science and technology development and we need to work with them, learn from them, and coordinate with them so that we can make sure that advances in science and technology are delivered to the public in the ways that will be most beneficial.
Since stepping down from the FDA, what have you been working on? Do you have any thoughts about what you would like to do next?
I have been very busy since stepping down, far busier than I expected to be, but I am still trying to find my way in terms of what I want to do next. Coming out of a job as intense as the FDA, I have been enjoying having more unstructured time. I have a part-time role as the Foreign Secretary for the National Academy of Medicine (what used to be called the Institute of Medicine), the medical branch of the US National Academy of Sciences, which is the very distinguished organization created originally by Abraham Lincoln to provide scientific and data analysis to inform policymaking. As Foreign Secretary, I am the liaison with other academies of medicine around the world and am very engaged in issues of global health and science, so that has been interesting and fun. I have also been trying to be involved in a broader array of issues than I was involved with at the FDA. While the FDA’s remit was very large and touched a lot of issues, it was still in a regulatory context. Now I am enjoying the chance to work on a broader set of issues, going back to some of my earlier interests in global public health but also engaged more with health care reform and looking at health care systems more broadly, working on issues around the environment and health and disease, and trying some new things. I am sort of in a period of transition, trying to figure out what I want to be when I grow up, or at least what I want to do next.
I am very grateful for having had the opportunity and the privilege to be the FDA commissioner for almost six years, but also recognize the importance of knowing when it is time to move on to new things. I felt very good about my tenure at the FDA in terms of what was accomplished. Many people had warned against being very ambitious in what I set out to do there because it is very hard to change institutions and to make an ongoing difference. But when I reflect back on what got done during my tenure, I feel that we made very dramatic strides in terms of improving understanding of the FDA and building trust and confidence in the agency, in terms of strengthening science and shaping a new focus on regulatory science and its importance to the overall scientific enterprise, and importantly, on globalization and repositioning the FDA for the demands and challenges of a globalized world.
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