 Good morning and welcome to CSIS. I'm Steve Morrison. I direct the Center for Global Health Policy here at CSIS. And we're delighted and honored to host here today Dr. Margaret Hamburger, FDA Commissioner. We're also thrilled that David and Betty Hamburg, her parents, are here today. And welcome, special welcome to them for being with us today. David's a legendary figure here in Washington for those who work on conflict issues and the prevention of conflict. And so it's really delightful to see you both here today. I also want to thank some of the people who helped us put this event together, particularly from the FDA side, from Molly Muldoon, Art Allen and George Strait, who put a lot of effort into making this happen. On our side, Emily Poster and Daniel Porter and Karen Meacham put a lot of time in and coordinating and mapping this out. We're here really to hear from Dr. Hamburg about a rising dimension of global health, one that's really been underappreciated, but through her leadership and that of others, is now getting a much more careful consideration. And that's the international food and drug safety challenges that are before us. And the U.S. role that that implies in terms of protecting American consumers, bringing inspection closer to the point of origin, building partnerships with other governments and with industry, including inspection capacity, building inspection capacity with partner governments, and using our diplomatic tools and our relations with key multilateral and intergovernmental institutions to get better results. It's a very, as we'll hear from Dr. Hamburg, this is a daunting, complex, and quick-evolving set of issues and challenges. And it's really a major moment in which these are coming forward and we're beginning to see them. And it's a frightening moment, but it's a hopeful moment in terms of what we can do as we set a course. And it's one where U.S. leadership remains essential, but it's just one component. Let me digress for just one short moment here to say something that's relevant, which is that back in April here at CSIS we started a commission on smart global health policy. And it's co-chaired by Helene Gale and Admiral Fallon and it's 25 very diverse, very prominent American opinion leaders who agreed to take on this job over the following 10 months considering what is at stake for the U.S. national interest in terms of global health and what might a long-term strategic approach look like. And we'll be rolling that report out next week, February 10th beginning at 9.30 a.m. at the Mayflower Hotel and I invite all of you to come. If you can't come, it will be webcast live on the smartglobalhealth.org site. But other than advertising that event and the many different people from Congress, from business, from government, from media and philanthropies who are part of that group of 25 opinion leaders, we also put a special focus in that report. Didn't go into considerable detail, but we did flag that this is, the international food and drug safety issue is now, there's no question a very vital dimension of global health. And we did get our four members of Congress and our 21 other members to sign a consensus document calling upon Congress to really strengthen the mandate, the authorities, the resources and the skills that FDA will require to move forward with this agenda looking out. And I'm very proud that we were able to get a consensus around that position and I'm very indebted to one of our colleagues we'll hear from today, Tom Boyke, who did the analytic work that we published earlier this year. You have that paper, we distributed it today, that provided the background really for persuading the commissioners that this really is a vital part of this. Please, I hope I encourage you all to read Tom's work. Now back to what we're going to do this morning, where I'm going to introduce Peggy momentarily and she will speak and deliver her speech for 15 or 20 minutes and there's a short video tied to one of the announcements that contained in her speech that will come right at the conclusion of that. And then we will move from that segment of the program to a more interactive roundtable discussion and that will include Tom Boyke from Center Global Development. That will include Dr. Henry Chin, food and safety director at Coca-Cola and it will include my colleague from CSIS, Reuben Jeffery, former Under Secretary of Economic Business and Agricultural Affairs at the Department of State, who's now a senior advisor here at CSIS. And we'll carry on a more interactive conversation for a couple of rounds and then we'll open the floor to you for comments and questions. Please keep those very brief and people will be bringing microphones to those of you who put your hand up and wish to have an intervention and we'll cluster those into two or three at a time and come back to our panelists. Now our keynote speaker, Dr. Margaret Hamburg, is an esteemed medical doctor, a scientist, a public health expert, a public health executive and now the commissioner in charge of the Food and Drug Administration. She's a graduate of the Harvard Medical School. She began her career as a scientist, as a neuroscientist at Rockefeller University, as a researcher on neuropharmacology at NIH where she became an assistant director at NID. She went on to become, in the early 90s, to become the commissioner of health in New York City during a period in which the city faced a grave challenge from a tuberculosis outbreak that required quite courageous and determined efforts to bring those under control under her leadership. Tom Frieden was part of that effort as well, who's now gone on to CDC. She, several years later at the request of President Clinton, took on the position of assistant secretary for policy and evaluation in HHS. And after that became a leading figure in the nuclear threat initiative, became the senior scientist there and one of the leading figures in standing that very important initiative up. I'm very proud that CSIS was able to play a role in scoping that and organizing that and building the credibility and legitimacy around that initiative and I hope that we can continue to play a similar supportive role as FDA attempts to move this very vital agenda around international food and drug safety forward. So please join me in welcoming Dr. Hamburg. Thank you. That wonderful introduction and I fear that in some ways you've already given all the important points in my speech, but it's always good to have important information reinforced and I must say I'm delighted to hear about your global health report that's coming out. I knew about the activities of the group, but I did not expect that you would be putting in a targeted plug for the FDA and for that I'm immensely grateful and very pleased to be here this morning to talk about an issue that is so important to FDA and so important to the American people and in fact so important to the peoples of the world which is the safety of food and medical products in a global age and I think that we'll have an opportunity to have a lot of interesting discussion with the panel that follows and also drawing on the expertise of this distinguished audience and I really want to take a moment to compliment Tom Boyke wherever he is for the excellent paper that he put together. It really was I think an extraordinary overview of the nature and scope of the problem and what are some of the important solutions we need to pursue. I'm also pleased that I can take this occasion to at least semi-formally announce a new FDA program that should bring us a step closer to assuring the safety and quality of imported foods. So let me say a little bit on this topic. Since I assumed FDA leadership a little over eight months ago every single day has been an opportunity for me to delve more deeply into another aspect of the vast and complex mission of this agency an agency that touches the lives of all Americans in the most fundamental ways. One of our nation's greatest champions of public health, the late Senator Kennedy once said that the FDA is the most important health agency in America and I think some people raised their eyebrows a bit at that thought but every day I spend on the job I gain a deeper understanding of what Senator Kennedy meant and a fuller appreciation of just how right he was. For one thing I did not truly appreciate how crucial and unique the FDA is as a science-based regulatory agency with a mission to protect and promote the health of the public it does have a very special role in addressing threats to health and as a gateway for products that people need and use and virtually all of our responsibilities are ours alone when we succeed the gains for health are enormous and if we fail there's no one to backstop behind us and do our job. Our responsibility and reach is enormous consider that the FDA regulates products that account for over 20% of every dollar of consumer spending in this country food, drugs, medical devices, vaccines and biologics, cosmetics, dietary supplements animal drugs and food tobacco products and certain products that emit radiation. Today the agency faces a daunting set of tasks and globalization has surely multiplied the scale of our responsibility and the challenges we face. Consider that FDA regulated products are currently imported from more than 150 countries with more than 130,000 importers of record and from more than 300,000 foreign facilities. This year we expect that nearly 20 million shipments of food, devices, drugs and cosmetics will arrive at US ports of entry. Just a decade ago that number was closer to 6 million and a decade before that only a fraction of that. It's estimated that somewhere around 15 to 20% of all foods now consumed in the United States originate outside our borders in fact some 75% of all seafood and about 35% of fresh produce consumed in this country come from outside our borders. Strikingly also those are some of the food stuffs that are most subject to potential contamination. Up to 40% of the drugs Americans take are imported and about 80% of the active pharmaceutical ingredients in those drugs come from foreign sources. So we're definitely talking about real numbers and imported medical devices are another rapidly growing area. The rise of imports has brought clear benefits to the American people. We can eat a huge variety of delicious products from around the world and enjoy all kinds of fruits and vegetables way out of season. We can benefit from medical innovation across the globe and we can get certain products more cheaply than might otherwise have been possible. Yet this tremendous shift in the global market for food and medical products also has brought important new challenges. In addition to the sheer volume of imports in foreign facilities there's been an increase in the variety and complexity of imported products and a large expansion in the number of countries involved in producing these products including many with less sophisticated regulatory systems than our own. Simultaneously the supply chain from manufacturer to consumer has become more and more complex involving a web of repackagers and redistributors and making oversight significantly more difficult. So this all adds up to an enormous task for FDA and we know that there are very real concerns. A few examples. In early 2007 melamine containing protein ingredients manufactured in China made their way into U.S. pet foods and animal feed causing illness and death among household pets across the country. This incident also had major economic consequences including the recall of hundreds of brands of pet food and state quarantine or voluntary holds on livestock that had consumed suspect feed. Although these melamine tainted ingredients were only found in animal products in the U.S. it's not difficult to imagine that they might just as easily have been used in the U.S. production of human food products and in fact melamine did appear in Chinese infant formula causing an estimated 300,000 illnesses and at least six deaths in China and prompting worldwide recalls of milk containing products and unfortunately melamine contamination appears to be a persistent problem as only last week Chinese authorities announced that they were pulling more milk products contaminated with the chemical from store shelves. Soon after the melamine incident the highly poisonous industrial chemical diethylene glycol or DEG was found in toothpaste imported from China. Thankfully FDA was able to issue import alerts which led to voluntary recall of the contaminated products before they brought harm to U.S. consumers. However other countries have not been so lucky. DEG contaminated products have led to scores of deaths elsewhere in the last several years and the year before last many of you may recall the tragedy that occurred when contaminated heparin a blood thinning drug came from China and caused deaths and hundreds of allergic reactions here at home. These episodes were particularly disturbing because they represented economically motivated adulteration truly despicable acts of seeking profit by putting lives at risk. We see this also in the worldwide marketing of counterfeit medical products. Here in the U.S. federal and state authorities have done a lot to keep counterfeiting of drugs to a minimum because of our extensive system of laws, regulations and enforcement but it requires constant vigilance and the problem is growing. Counterfeit drugs represent a much more vast and greater threat in the developing world where the system of laws and regulatory oversight do not afford such protection. Numbers are hard to substantiate and estimates vary considerably but we know the numbers are worrisomely high. Studies in some countries suggest that between 30 and 50% of certain available drugs are actually counterfeit. Needless to say, this is devastating to health and safety. And in our modern world, profits isn't the only dark motives that we must face. Sadly, we know that we're also vulnerable to potential attacks involving our food and drug supply by terrorists determined to do harm. And while it's easy to focus on the most dramatic scenarios there have also been many other significant but less intentional episodes associated with contaminated and adulterated products, both food and medical goods. Outbreaks associated with melons, peppers, raspberries and seafood have all been in the headlines in recent years to name a few. In addition, every day FDA rejects imports at the border for a range of problems including illegal drug residues, bacterial contamination, unapproved food additives, pesticides, heavy metals and just plain filth. Each of these crises and near misses is deeply troubling in and of itself. Their human costs, economic costs and sometimes an undermining of confidence in government agencies and critical institutions and in the products themselves. Even more troubling is the fact that these events are more than isolated incidents. They're symptoms of significant underlying problems and globalization has fundamentally altered our market landscape. When the modern FDA was created back in 1938 imports were a tiny part of the products used in our country. FDA's import inspection system reflected that fact and unfortunately it still does. Massive change will be required for FDA to be able to keep up with the globalized economy. It's easy to see that FDA faces a sycophene task if its employees are asked to inspect everything that enters our ports. The estimated 20 million shipments of FDA regulated imports that will come into the country this year will be handled by fewer than 500 inspectors. Though these employees do work tirelessly they typically are able to examine less than 1% of these products before entering into the United States. And I'm going to talk a little bit about some improvements in this area later. But it is simply not possible to count on interdicting everything harmful at our borders. Similarly, FDA cannot alone conduct a sufficient number of inspections at foreign manufacturing facilities to help ensure product safety. Current estimates are that FDA inspects only about 8% of foreign drug manufacturing establishments each year. So at this rate it would take us more than 13 years to inspect all registered foreign drug facilities and that's not to even mention those that are not registered. We're taking important steps to increase the number of inspections as well as follow-up inspections of establishments that previously had violations or deficiencies but it is simply not possible for FDA to inspect our way to safety. Clearly our nation's traditional approach relying on FDA inspections to catch problems at the border or in foreign facilities needs significant overhaul. We need to recognize that addressing the challenge must be a collective and collaborative effort on an international scale. And it will require fundamental and systemic change in the way we and all our trading partners think about import safety. To assure the safety of imported products and fulfill our public health mission in a global age, the FDA must adopt a new approach. An approach that takes into account the entire supply chain and its complexity and an approach that will address product safety by preventing problems at every point along the global supply chain from the raw ingredients through production and distribution all the way to our consumers. We must move from an approach based on reacting to problems to one that proactively prevents such problems from ever occurring. This is a simple yet profound paradigm shift. This idea is embodied in the food safety legislation now moving through Congress which would for the first time allow FDA to establish basic preventive controls throughout the food production process. This modernizing of our basic authorities is critical to our success as a public health agency and a regulatory agency in the 21st century. And we must apply this basic principle of prevention to all imports. And we're starting now to make this shift. So let me share a few elements of our overall strategy. First, we're seeking better controls at the point of production. This is a shared responsibility among manufacturers who have the primary responsibility for the quality and safety of their products, national regulatory agencies which we're supporting through collaboration and with technical assistance. And the global regulatory community which must come together as never before. We're moving into a phase in which FDA works with regulators, manufacturers and suppliers wherever they are. We now have permanent FDA offices in Beijing, Shanghai and Guangzhou, China in New Delhi and Mumbai, India in San Jose, Costa Rica, Mexico City Santiago, Chile and soon Amman Jordan. These offices enable us to have a regional presence around the world and a home base from which to undertake a range of important activities. We're working with these countries and others to help assure oversight and regulatory capacity. By helping more countries build their regulatory capacity we build confidence in the safety and quality of the goods they send us. But we're doing much more. We're helping them establish the regulatory powers necessary to support safe products for their own domestic use and a strong, reliable export market. This will benefit their health and development in very fundamental, long-lasting ways. In addition, there's also much important collaborative work to be done with allies who already have well-developed regulatory systems. In fact, we now have more than 30 agreements with foreign counterparts to share inspection reports and other non-public information that can help us better in the decisions we have to make about the safety of foreign products. So, if a shipment of fish contaminated with a banned fungicide, for example, shows up in a port in Italy, we'll hear about it swiftly and beyond the lookout for products from that same shipper. But if our British counterparts share with us critical information about their inspections of certain factories in China or Egypt or Thailand, we can use that information and not reinspect those same facilities behind them, but rather use our resources to inspect elsewhere to get to places that otherwise none of us would have seen. For example, FDA and our partners in the European Union and Australia are jointly planning and conducting inspections of facilities in countries that manufacture the starting materials for many of our drugs. And we also now have FDA staff working in the offices of key regulatory agencies overseas to build on these relationships, and we have EU representatives working with us here. These programs are promising, and all of them make one thing clear. To address import safety, we will not be able to go it alone. A second key element of our strategy is to hold importing companies responsible for their supply chain. In this day and age, companies must be able to effectively demonstrate that safety, quality, and compliance with international and U.S. standards are built into every component of every product at every step of the way. Some companies already do a terrific job at this, tracking where and how their products are made and the paths by which they reach our shores. Obviously, companies have a vital interest in assuring confidence in the safety and quality of their products and in their brand. These best practices need to become standard practice throughout industry. And FDA will work with industry to set standards for technologies and other approaches that can help them strengthen the safety of their supply chains. On the other hand, companies that sell contaminated products because of loose supply chain oversight need to face serious penalties and cannot excuse themselves by blaming their suppliers, blaming the FDA, or blaming anyone else. Only when we have a sense of shared responsibility and accountability will we have a truly safe global supply chain. Third, we, FDA, have a responsibility to deploy our agency's resources as strategically and efficiently as possible. This is more critical than ever, as our mandates keep expanding despite these economically challenging times. And in this regard, I want to take this opportunity to announce a new FDA program that will enable us to more effectively and efficiently do import inspections. I've already discussed how in today's world we simply can't be guardians at the gate attempting to detect and weed out dangerous and contaminated products at our borders and ports. But as part of a comprehensive program, we still need screening at our borders, and we can and must do it in a much more meaningful way. The system we're now deploying is called Predict, the predictive risk-based evaluation for dynamic import compliance targeting. It's a sophisticated information technology system developed for use by our border inspection operations that will allow us to monitor products at the port of entry more reliably and to target shipments for inspection that pose the greatest risk. The system was piloted in the Los Angeles area, their very large and active port, and we're currently bringing it online in New York. Hopefully, we'll have it up and running throughout the whole country by sometime in the spring. With Predict, investigators will still be checking only a small percentage of all import shipments, but they'll be using better intelligence to decide which shipments to check. Predict uses a variety of assessments to rank import shipments according to risk. It considers everything from whether a product is intrinsically risky. Raw seafood, for example, falls into that category. To information we've acquired from previous examinations of shippers or producers. We also can add information on things that might seem surprising, like floods, hot weather, or market conditions that suggest whether a particular shipment is at risk of being spoiled or shoddy. These and other factors are added up to give a risk score, and the riskiest items are the ones that our investigators will check first. We expect Predict to offer two major benefits to FDA inspectors, to importers, and to the public. First, the system will automatically flag potentially risky shipments. Second, the system will give lower risk scores to more innocuous materials, which can then be cleared through FDA inspection rapidly. This allows FDA inspectors to spend their time looking at the highest risk items. It also means that carefully labeled products with good histories will be held for shorter periods, and that is better for everyone. So as mentioned, I have a short video demonstrating the Predict system in action, which I think we're going to show at the end of my remarks. It's only about four minutes, but it is something that we're very excited about. This is a major innovation that harnesses advances in information science to enable us to do our job better and to improve our service to the nation. But it's just one step. More broadly, we're moving from a system that places most of the regulatory burden on the FDA's modest inspection force to one that creates greater oversight at points further back along the production chain. We need to know who is making our food and drugs, where they're located, and we need to be sure that these facilities are being inspected and are accountable for what goes into their products as well as for the products they produce. We need to create a global safety net. I can assure you that addressing the problem of global supply chain safety and shifting the existing paradigm from reaction to prevention is one of my highest priorities for the FDA. Refining our understanding of the problem and exploring and assessing and implementing possible solutions will be a major focus of our work over this next year and well beyond. Ironically, 70 years ago, DEG, the same poisonous chemical found just a few years ago in tainted Chinese toothpaste and other products, precipitated another similarly significant shift in the FDA's approach to product safety. In 1937, 105 people in the United States died after ingesting elixir sulfonylamide, an antimicrobial medication that included DEG as an ingredient. In response to this tragedy, Congress passed the 1938 Federal Food, Drug and Cosmetics Act. As a result, FDA moved beyond simply responding to problems and intercepting adulterated drugs on the market. We began to conduct pre-market evaluations to prevent unsafe drugs from entering the market in the first place. The most recent DEG episodes show that we need another fundamental change in the way that we do business, this time on a global scale. This will require new ways of thinking and new partnerships, in addition to new resources and new authorities. Now is the time for FDA to fully engage bilaterally, multilaterally, and through international and regional organizations to work with countries throughout the world to have scientific and technical expertise, to harmonize international standards for safe food, drugs and medical products, to work with industry to enhance compliance with standards, and very importantly, to help countries with less mature economies and regulatory systems build capacity so that they can produce food and commodities that are safe, wholesome, and meet international safety standards, for their own consumption and for export. Such an approach represents a shift to a new paradigm for safety, and it will not be easy to accomplish. We will need to marshal the support of our stakeholders, our international partners, and Congress. However, the benefits of this new paradigm for global product safety go well beyond our borders, and in fact, they go beyond health. When governments collaborate to invest in the capacity of countries to produce food, drugs, medical devices, and cosmetics for export in accordance with strong safety standards, there are multiple and mutual benefits. Although my duty as FDA commissioner is to protect the health of the American people, and importantly, the safety of our nation's food and drug supply, my experiences throughout my career have shown me time and again that public health protection is a global endeavor. All people in the world deserve safe food and access to quality medical care. All nations deserve the opportunity to participate and prosper in the global economy. We, as an agency, have difficult work ahead of us, but this is a challenge that we're eager to meet. And I know that if we are to meet it, it must be done in partnership. I welcome the opportunity to hear from the panel and from all of you about strategies that can help us move forward toward a global vision for import safety and how we can do it together. Thank you very much. And I think if you'll indulge me before we go on to the panel, we're just going to show you this brief video clip about Predict because this is our formal launch. And as I said, we're very proud of this program. It may slightly repeat some of the framing that Aldi was done in my remarks. But I hope that you'll find it interesting. Officials don't know yet where the E. coli came from. Foodborne outbreak in at least one house. Now, another company has come. Despite recent and well-publicized problems, the FDA's record for keeping unsafe food, cosmetics and medical products out of U.S. commerce is extraordinary. But with almost 20 million shipments from hundreds of countries coming into the U.S. last year, a number that is continuing to rise, a basic challenge for the FDA is now how to best ensure that these imported products are safe. Globalization has fundamentally altered the markets for food and medical products, and FDA needs to change in order to keep up. Change because the current safety system has been plagued by too few inspectors operating a system at our ports that has been described as rudimentary, manual and reactive. Dan Solis is in charge of inspections at the port in Los Angeles. A lot of it was hit and miss. Oftentimes, there's information provided to them and it wasn't matching up with what they actually see. But by the end of this year, FDA inspectors across the country will begin to use a new web-based system. It's called Predict, the name that mirrors the agency's new approach to food and medical product safety. Prevent problems before they occur. Predict is about taking prevention to a whole other level. We simply can't look at everything. The volume of entries that we have has been growing exponentially over the past decade, and what we really need to do is to further target our resources to those entries that present the greatest risk to the consuming public. And Predict is a real good tool to help us do that. This is the port of Los Angeles. It's the largest port in the country. More than a thousand ships a day unload their cargo here. Huge warehouses like this one receive shipments from around the world that include everything from frog legs to fettuccine, from pacemakers to surgical lasers. Inspectors here have been using Predict to see the improvement has been remarkable. So this system does everything for you. Automatically as soon as the information is transmitted it does it all for you. That means you're less likely to miss something. Yes you are. Predict works this way. Each product when it's unloaded is checked for a specific product code. That code is transmitted to FDA headquarters where inspectors operate Predict. The computer system is attached to or can access hundreds of databases with all manner of product information. Such as the manufacturer, country of origin, has the product or the processor ever been part of a recall? Is the product susceptible to being a security risk? Tamara Alexander is inspecting a load of specialty seafood from Asia. I'm actually looking for if the manufacturer is on import alert, if the product is on import alert and then what it was, do we have any history for this product? It's going to find patterns that may not be obvious to our interviewers as they're looking at an individual entry. In just a few minutes Predict scans all of that information, assesses the risk, and gives the inspector a score. If there is a problem a red flag appears. It's had a previous violation from a previous manufacturer so that we have to detain it coming in. These products from South Africa inspectors stopped their entry and are preparing to have them tested for contamination. Before Predict, these inspectors picked shipments at random and decisions were often based on educated guesses. You'd have to do a lot of it manually or by manually. So much for technology, huh? The factor is from all around the world so there's no way to remember everything. Exactly. Yeah, so it's kind of a hit and miss before. Predict allows FDA's limited number of inspectors to look at products for which there is evidence that they are a real threat. This is actually Miss Predict. It's a cosmetic product that has a drug cleaned on it. This is where products that pose the greatest threat end up destroying before they can become a problem. Okay, thank you. I think, you know, part of why we want to show there is just because the seas of the port I think do give, you know, a real sense of the volume and the complexity and the challenge. But we're ready to either go on to the panel or questions, whichever you... Okay, great.