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Glenn W. Kilpatrick Memorial Address
AFDO 116th Annual Education Conference
June 3, 2012
Ms. Deborah M. Autor
Deputy Commissioner for Global Regulatory Operations and Policy
Food and Drug Administration
Thank you, Oscar, for that kind introduction.
It’s an honor to be here with you today. AFDO has played such an important role over the years by fostering national uniformity in food and medical product regulation and by fostering integration of Federal, State, and local food safety activities.
AFDO is a truly unique organization, and you are to be congratulated – and thanked – for your many notable public health initiatives involving food and drug officials from all across the nation and all levels of government.
Glenn W. Kilpatrick
As was mentioned, I am here to present the Glenn W. Kilpatrick Memorial Address. In preparing to be here today, I’ve learned about Mr. Kilpatrick’s approach and his vision. That approach and vision are as applicable today as they were decades ago.
Mr. Kilpatrick worked at FDA during the 1960s and 1970s, and he established many of the cornerstones of the relationship between FDA and the States. First, he recognized the importance of communication between FDA and the States. He planned and inaugurated a system of rapid communication between FDA headquarters, regional and district offices, and key State offices. He also instituted planning and informational conferences between associations of State and local officials and the FDA, as frequently as he could. These kinds of efforts continue today, as you well know.
But Mr. Kilpatrick went much further than instituting better communications; he had the vision that the Federal government and the States could share responsibility in areas where our authorities overlap. He significantly increased the commissioning of State officials so that they could carry out activities on behalf of FDA. Building on that, Mr. Kilpatrick originated the program, still in existence today, through which FDA contracts with the States to carry out inspection activities. This approach has significantly expanded the inspectional coverage of FDA-regulated goods and firms over the years.
Mr. Kilpatrick worked towards a future in which the Federal and State governments could collaborate more closely, each bringing its own strengths to a mutually beneficial partnership for public health protection.
The Impact of Globalization
Today FDA faces a new challenge, the challenge of globalization, which did not really exist during Mr. Kilpatrick’s time. Globalization affects every type of product FDA regulates, and it demands a major change in the way FDA does business. The example of Mr. Kilpatrick’s work is very relevant, as I will explain.
The world was a very different place when President Franklin Delano Roosevelt established the modern FDA in 1938, and likewise in the 1960s and 1970s when Mr. Kilpatrick served in FDA. In those days, FDA products were overwhelmingly manufactured within the United States, and the volume of FDA-regulated imports was low.
Today, however, that picture has changed drastically. FDA is grappling with the challenges of global supply chains, international trade, and foreign sourcing of FDA-regulated products. Just as public health leaders have long recognized that disease knows no borders, we now see that product development and product safety and quality no longer begin or end at the border.
The United States now imports 40 percent of finished drugs, and a stunning 80 percent of the manufacturers of active pharmaceutical ingredients in our drugs are located outside our borders. Similarly, for medical devices, half of all devices used in the United States are now imported.
Turning to the foods area, 10 to 15 percent of the food consumed by U.S. households is imported, and when we look at some individual food products, the level of imports is much higher: approximately 50 percent of fresh fruits and 20 percent of fresh vegetables come from abroad. And 80 percent of seafood eaten in the United States is imported.
FDA-regulated products now originate from more than 150 countries, 130,000 importers, and 300,000 foreign facilities. Not only are more finished products imported, but manufacturers increasingly use imported materials in their U.S.-based plants. In addition, in the foods area, U.S. firms are making business decisions to take raw materials grown or raised in the United States and ship them overseas for processing. Those products are then being shipped back to the United States for either direct sale or further processing or packaging.
Another aspect of the challenge facing us is that global supply chains tend to be complex, and we are seeing increasing numbers of firms involved in the production of a single product. In the foods area, the production of a single commodity such as a can of tuna can involve the efforts of multiple parties from different geographic regions who fish, process, can, or distribute the product. The fish might be caught in the South Pacific and processed into frozen pieces. It may then be transported to New Zealand for pre-canning or canning, before being sent on to Southeast Asia for further canning or processing. Next the cans may be shipped to the East Coast of the United States and from there distributed throughout the rest of the country, where consumers buy it for their meals. Our foods and medical products are truly world travelers.
In these types of international supply chains, regulators face the question of how to deal with the risks of the unknown with respect to product quality and integrity – Who has handled the product? How was the product manufactured, packed, distributed, and stored? Who supplied the ingredients?
Increased complexity can also present challenges to product safety and security. Increasingly, regulators – as well as industry – must contend with ever more sophisticated threats of fraud, product adulteration, and even terrorism. And the reality is that manufacturers and others in the supply chain around the world may place economic gain above safety and public health or have more malevolent motivations.
Moving FDA Towards a Global Operations Paradigm
FDA has established a number of significant building blocks during the past decade to address the challenges of globalization. First, we have engaged very actively in global harmonization initiatives, through which FDA and its partners have developed common standards. Second, FDA has signed 54 arrangements that enable the exchange of confidential information with foreign regulators in 23 countries, the European Union, and with a few multilateral organizations such as the World Health Organization. These arrangements, similar to our agreements with the states or the commissioning of state officials that Mr. Kilpatrick initiated, permit FDA and regulators to work together more closely and effectively. Third, building on the confidentiality arrangements, FDA has developed many highly effective bilateral relationships and some multi-lateral relationships with its foreign counterparts.
Finally, in the last few years, FDA has established a foreign presence, with 13 FDA posts in other countries. FDA staff who are stationed abroad work to increase our cooperation with foreign regulators, build FDA’s knowledge of foreign industry practices, educate foreign industry about U.S. requirements, provide technical assistance to foreign governments, and conduct a portion of the agency’s foreign inspections.
Examples of all of these key building blocks are highlighted in a report recently published by FDA entitled “Global Engagement.” You will find copies of the report in the hallway after my talk.
All of FDA’s international activities that I’ve mentioned are very significant. Yet, I call them “building blocks” for a reason: They have established valuable mechanisms for working with the international community, and now we need to further expand the use of such mechanisms and use the lessons we have learned from our domestic and international partnerships to build an even more integrated system of working with our international regulatory partners. In light of the huge scope of the globalization challenge we face, it is clear that we must find a way to leap-frog ahead.
FDA’s Commissioner, Dr. Margaret Hamburg, has made FDA’s response to globalization one of her top priorities. In late 2010, Commissioner Hamburg established the Globalization Steering Committee, a cross-section of Agency experts tasked with developing a framework and action plan to guide FDA’s future regulatory strategies for imported products.
The Committee released a report, entitled “Pathway to Global Product Safety and Quality,” which sets forth a plan for the FDA to proactively anticipate and prevent the arrival of harmful products into the U.S. marketplace. The report describes how FDA will transform itself from a domestically-focused agency to a public health regulatory agency fully prepared for a complex, globalized regulatory environment. The ultimate goal is to move from a primarily domestic orientation to one that treats like risks in equivalent ways, regardless of geographic location. Copies of that report are also available in the hall.
The Commissioner has also created an organizational structure to facilitate implementation of the “Pathway Report.” As part of an agency reorganization, she established my new position, Deputy Commissioner for Global Regulatory Operations and Policy. My directorate, which is one of four that now comprise the agency, includes both FDA’s Office of International Programs, which leads the agency’s global engagement work, and the Office of Regulatory Affairs, which is our field component and provides leadership on imports, inspections, and enforcement policies.
Commissioner Hamburg has charged my directorate with making FDA’s response to globalization and import safety a top priority. The Commissioner directed us to implement the recommendations in the Pathway Report and to ensure that FDA fully integrates its domestic and international programs to most effectively promote and protect public health.
Thus, the groundwork has been laid for FDA to implement a new strategy for global product safety and quality.
Since the Pathway Report is so central to the work of the new directorate, let me take a few moments to describe its core tenets to you. The report presents a strategy with four distinctive components, or “pillars.”
The first pillar involves the creation of global coalitions of regulators focused on ensuring and improving global product safety. As I mentioned, over the past decade, FDA has typically engaged in close cooperation with a number of regulatory partners via bilateral agreements. We now envision a much deeper engagement, beginning with a core group of partners. A primary aim of these coalitions would be to develop procedures for more comprehensive and systematic information sharing and coordinated deployment of resources. The goal for FDA is mutual reliance. We cannot do it all alone. We need to learn from others, work with others, and leverage resources globally.
By the way, this is not so dissimilar from what Mr. Kilpatrick, whom we are honoring today with this presentation, was trying to do. In his world, where most FDA-regulated products were produced domestically, in the States, Mr. Kilpatrick had a vision of increased partnership between FDA and the State governments. Today, when so many FDA-regulated products on the U.S. market are produced in foreign countries, we are envisioning increased partnership with foreign governments, as well as with the States.
Getting back to the pillars of the Pathway Report, the second pillar of our global strategy involves building global data systems and networks and proactively obtaining data from our foreign regulatory partners and sharing data with them. It is essential that the Agency be able to aggregate and analyze multiple sources of information to identify risks and emerging trends. We need to identify critical data elements, better standardize our reporting, and create properties for regular systemic information exchanges. This would include the use of unique facility identifiers, perhaps Dun and Bradstreet’s D-U-N-S numbers that could enable us to crosswalk data coming from multiple sources about a single facility.
Ultimately FDA will work with its regulatory partners to develop a process for regular, systematic information exchange that will provide essential inputs into FDA’s risk modeling and analyses.
The third pillar of the Pathway Report involves the expansion of intelligence gathering, with an increased focus on risk analytics and thoroughly modernized IT capabilities. Risk analytics can inform our priorities in inspections, training, regulatory cooperation, and surveillance efforts. As we monitor and analyze data, we must also work proactively to identify vulnerabilities and increase our capabilities to interpret and act on such data. FDA has been doing risk analytics for a long time, but we want to take a more proactive, systematic, and global approach.
The fourth and final pillar of the Pathway Report involves leveraging the efforts of public and private third parties. One of the most fundamental changes that FDA will undertake is a more effective deployment of its own resources. We need to ensure that our standards are well understood and fully applied, foster best practices in industry, and foster innovation to drive safety and quality. In addition, FDA intends to establish relationships with third parties on whom we can rely, create a review and audit infrastructure to verify the integrity of the information that we receive from public and private third parties, and ensure that the Agency can act on that information.
We at FDA believe that the four pillars I’ve briefly described will move FDA towards strategic and risk-based global industry oversight. The Agency will continue executing the broad range of surveillance, intervention and enforcement activities that are currently in its toolbox for preventing product-related harms. However, we need to think more creatively about what other tools we can deploy to maximize product quality and safety. We will have considerably more information at our fingertips to conduct risk analysis and determine the relative magnitude of risks. We will create tailored, flexible strategies for addressing risks, and we will do so with our many partners.
With that, I’d like to take a few minutes to talk about Federal-State cooperation. And when I use the terms “States” and “State governments,” these are short-hand terms that I’m using to include regulatory and public health officials in the States, localities, territories, and tribes.
Even in a global economic system with an increasing amount of product coming into the United States from abroad, FDA cooperation with the States continues to be absolutely vital. State governments are performing surveillance, conducting inspections, testing products, and giving FDA feedback that is truly essential for assuring the safety of products on the U.S. market. Federal-State cooperation enhances consumer protection by expanding the product safety net.
Cooperation in the foods area is particularly crucial at this time, since there has been a general recognition that the system for U.S. food safety needs to be strengthened. Federal-State integration is an essential component of a stronger national food safety system. Furthermore, increased Federal-State integration is required by the Food Safety Modernization Act as part of a new regulatory paradigm for foods.
In this regard, FDA remains committed to the Partnership for Food Protection, which has done a terrific job in moving us forward collectively towards an integrated food safety system – and by “us,” I mean four Federal agencies, and State, local tribal, and territorial entities. FDA has convened two 50-State meetings in conjunction with the Partnership for Food Protection; these meetings brought the groups together to develop recommendations for advancing the integrated food safety system. Ten working groups, with joint Federal/State/local leadership, then do the hard work of developing national standards, guidances, standardized procedures, training programs, collaborative work assignments, and other tools to implement the 50-State recommendations. It’s been a tremendous and very fruitful undertaking, and FDA remains committed to the Partnership’s efforts.
FDA also remains committed to other initiatives that advance Federal-State integration. One important example is the placement of dedicated State liaisons in FDA’s district offices. The State liaison positions were created to serve as centralized points of contact at the district level to ensure effective collaboration and coordination of FDA activities with State programs.
Another example of FDA’s commitment to advancing Federal-State integration is the creation of Rapid Response Teams. Through a multi-year cooperative agreement, FDA is supporting the development of nine of these teams, which conduct integrated, multi-agency responses to food and feed emergencies. Because of the success of these nine initial Rapid Response Teams, FDA is planning to support up to five more teams in 2012.
In addition, as many of you may be aware, FDA awarded a cooperative agreement to AFDO in 2011 under the “Alliance for Advancing a National Integrated Food Safety System Cooperative Agreement Program.” In addition to other activities, the award funds AFDO to work with FDA to establish a network of manufactured food program managers and to host an annual program managers training to build operational and strategic partnerships. In addition, AFDO and FDA will develop and implement pilot projects to support the adoption of the Manufactured Food Regulatory Program Standards by State and local governments and to collaborate with other partners to identify, develop and deliver food safety and defense training programs.
This cooperative agreement with AFDO is an important step. But at the same time, we in FDA recognize that we must go much, much further in terms of cooperation and integration with State and local governments. To that end, Commissioner Hamburg has established an Integrated Food Safety System Task Force, which has been studying how the States and FDA can work best together.
The Task Force will identify the enhancements needed to ensure full adoption of an integrated food safety system. The Task Force is analyzing the current state of the Federal-State partnership and will produce both short-term and long-term recommendations.
I personally am very interested in seeing some robust and useful recommendations from the Task Force. I fully agree with the State and local officials who have called for strengthening Federal-State integration, improving communication, and transforming our partnership into one that operates more seamlessly and effectively, supported by strong, positive working relationships between our people and our organizations.
We all have limited resources, and consumers are depending on the leveraging of all of those resources – Federal, State, and local – to build a strong and vibrant food safety system.
Bringing It All Together
Up to this point in my remarks, I’ve been talking about FDA-international partnerships and Federal-State cooperation largely as two separate creatures. In fact, that’s how these subjects are usually discussed. Certain sets of people pay close attention to Federal-State integration, and other sets of people think about Federal-international partnerships.
In fact, there are many parallels between what FDA and the States have done and are doing together, and the effort FDA is embarking on in the international arena. Federal-State cooperation through the Partnership for Food Protection provides an interesting model for the broad global coalitions that FDA intends to develop. The collaboration between FDA and the States in information sharing, intelligence signals, and leveraging of resources, and the mutual reliance we have developed, provide lessons that can be applied internationally. FDA’s State liaisons, who work with State regulatory partners, share similarities with FDA’s foreign posts, which work with foreign regulatory counterparts. The challenges posed by IT systems and exchange of confidential information are similar, whether looked at from a national or international perspective. FDA’s end goals – mutual reliance and equivalent treatment of like risks -- are the same, whether in reference to the States or to foreign countries.
While development of FDA’s international operating model is evolving, we - those of us in FDA and in the States - need to begin exploring where specific overlaps exist between FDA-State cooperation and FDA-international cooperation and how we will deal with them. Let me give you a couple of examples.
First: FDA and the States are working on models for collecting and sharing data in a systematic way. We need to think in terms of models that will also be able to incorporate international data sharing.
Here’s another example: as you know, quite a bit of work has been done on Federal-State integration in the area of laboratory cooperation through the Food Emergency Response Network (FERN) and the Electronic Laboratory Exchange Network (e-LEXNET). These are innovative programs that permit a more integrated laboratory response to food emergencies, as well as a data-sharing system that permits governments to share analytical results for foods, so that outbreaks of food-borne illness can be more readily detected. While working on increased laboratory integration within the United States, we also need to consider laboratory integration internationally and how it might mesh with our program for domestic laboratory integration.
We in FDA and the States need to develop responses to these issues and to identify other key issues that will need to be addressed.
Globalization impacts us all. In fact, I would challenge us to try to stop thinking of federal-state and federal-international as two different, perhaps overlapping areas of cooperation. In the long run, Federal agencies, States, localities, territories, and tribes, and our counterparts all around the world should form one network protecting our respective consumers, as well as consumers worldwide. We have in this room the brainpower to figure out how to bring it all together, and I can assure you that FDA will be very interested to hear about further thinking in this area.
To conclude, I want to re-emphasize a few key points.
Because of the fundamental changes brought by globalization, FDA must change the way it fulfills its mission to promote and protect the health of the American people. Over the next decade, FDA will transform from a predominantly domestically-focused Agency operating in a globalized economy to a public health regulatory agency fully prepared for a complex globalized regulatory environment.
At the same time, Federal-State integration will receive even more emphasis than in the past, as Federal, State, and local officials work together to strengthen the national regulatory system for food safety. And, FDA needs to take the lessons learned from working with our states to build an integrated system and apply it globally.
Lastly, we must think about how our Federal-State partnership can account for international issues. In some cases, this will mean expanding Federal-State mechanisms to incorporate global considerations. In other cases, it will mean considering how FDA’s growing partnerships with the international community may affect the States. At some point, I hope it will also mean having a discussion about more integration between the Federal-State partnership and FDA’s international partnerships.
I wish that Glenn Kilpatrick could be here to see our efforts. I feel sure that he would approve of them because they continue to implement his vision. Mr. Kilpatrick envisioned that public health protection could be improved through partnerships between regulatory agencies with overlapping missions. He championed the sharing of information and leveraging of resources. I believe, too, that he envisioned that partnerships would have a multiplier effect, so that the whole would be greater than the sum of its parts. And that is also what FDA is hoping to achieve.
This is a challenge requiring all of us to work together. The return on investment will be safer and higher quality products and increased safety and security for U.S. consumers and patients, as well as citizens worldwide.