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Andrew C. von Eschenbach, M.D. - White Oak

Remarks by
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
On the occasion of the dedication of White Oak Building One

December 18, 2008
This text contains Dr. von Eschenbach's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Introduction

Dedicating historic Building One on FDA’s White Oak Campus, where I and my successors will lead the Agency, is an appropriate time to reflect on the Agency’s recent past challenges and its future opportunities. I arrived at FDA in September 2005 from the National Cancer Institute (NCI), where I was immersed in a revolution of science and technology in healthcare – where new mechanisms of disease and new insights into their remedy were being revealed every day. As the NCI director, determined to apply this progress to eliminating the suffering and death due to cancer, I knew the critical role FDA must play to shorten the time for those new treatments to be available to patients. Upon becoming the FDA Commissioner I recognized this gold-standard regulatory agency of the 20th century was struggling: and as a result would be incapable of the enormous task of addressing the scientific and technological revolution of the 21st century. This would have tragic consequences not only for millions of patients with cancer but for everyone with an acute or chronic illness. Moreover, the rapid and radical changes in the world over the past few decades were outpacing the FDA’s capacity to comprehensively and adequately regulate its myriad portfolio of products especially in assuring their safety. For the first time in FDA’s 100 year history the fear of mission failure was real. It was clear that if the FDA was to maintain its stellar reputation as the world’s premier regulatory agency, it urgently had to undergo a rapid and radical transformation.

The magnitude of this transformation is reflected in the scope of FDA’s mandated responsibility to protect and promote the public health. This monumental task includes ensuring the safety, quality, and in most cases the effectiveness of products Americans rely on all day from the moment they get up in the morning, brush their teeth, shampoo their hair, drink a glass of milk, swallow a tablet to removing their contact lenses before bed. We rely on the FDA for our health when we eat, take a prescription or non-prescription medicine, or undergo a medical procedure. FDA regulates 80 percent of the American food supply -- practically everything we eat except for meat and poultry: All the drugs, vaccines, medical devices, blood products, and tissues for transplantation we depend upon; animal drugs and feed; and the cosmetics we use. Americans spend more than one-fifth of their consumer dollars on these necessities, and they fully expect the FDA to make sure that the FDA-regulated products -- which are essential for their health, quality of life and well-being -- cause them no harm, and perform as they’re supposed to.

Because of opportunities to promote public health by bringing the fruits of modern medicine to millions and because of the responsibility to protect the health of every single American, old, young and in utero, it was crucial that this agency undergo fundamental modernizing changes. But it would have to do so in the context of an already overburdened workforce and inadequate infrastructure while simultaneously meeting its mission every day of protecting and promoting the public health. Few organizations have ever had to face such a daunting challenge. But even fewer organizations have ever been as blessed with the quality and dedication of the FDA workforce.

To begin the transformation I chose five themes that would initiate systemic and systematic change. They were: prepare the agency for strong performance in the case of a public health emergency such as pandemic influenza; improve the FDA’s internal and external communications; maximize the use of electronic data and insights provided by the Human Genome Project and other discoveries leading to personalized medicine; continue the implementation of FDA’s Critical Path Initiative for modernizing scientific tools for the regulation of medical products; and advance FDA’s outreach globally to ensure that imported food and medical products measure up to the United States standards.

While addressing urgent FDA issues, these priorities served to foster trans-agency collaboration and would yield immediate benefit to the public. Furthermore, they were consistent with a theme of “modernizing the FDA” congruent with changes in health care driven by science and technology and the impact of globalization.

The Molecular Metamorphosis of Healthcare

Advances in science and technology have been producing the most profound transformation to ever take place in the history of medicine. Following the discovery of DNA, decades of research and investment in biomedical science and cutting-edge technologies have fueled a new molecular understanding of life processes. In the past, what physicians knew of human disease was what they could see, touch or detect with their senses, and their remedies were empirical. By contrast, what we’ve begun to understand are the fundamental genetic and molecular mechanisms operative in the disease process, and the person susceptible to diseases. As a result, our medical interventions are becoming more rational and sophisticated. This transformation is so profound and so radical that it can be called a metamorphosis—a molecular metamorphosis in which we can envision a future of health and healthcare that will be no more like the past than a butterfly is like a caterpillar.

We are learning that diseases are not events, but rather are processes that begin long before they become something we can detect with our traditional tools. Molecular discoveries are rapidly leading to an era of personalized, predictive, preemptive and participatory medicine. These advances are producing innovative diagnostic and therapeutic products whose regulation places great demands on the staff of our agency. To support the results of this “molecular metamorphosis,” FDA’s employees must incorporate modern science and technology in the agency’s regulations, and do so in a fashion that is consistent, predictable, transparent, and efficient. Our new regulatory framework must encompass the full spectrum of the discovery, development and delivery of these novel products; and as a result, the FDA can no longer be a gatekeeper deciding which regulated products can go on the market, but instead must be engaged in their total life cycle to foster their successful development, align them with regulatory requirements and monitor their post market performance.

The Role of Science

As it has done always, today’s FDA must make decisions about the benefits and risks of regulated products on the basis of firmly established scientific data; but in addition, it must employ new scientific tools and discoveries to facilitate rapid availability of life-enhancing and life-saving interventions. This dual role reflects a new tension between regulatory decisions that have to be based on established and proven scientific principles while at the same time utilizing knowledge emerging from cutting-edge scientific research.

Since its founding more than 100 years ago, FDA has led the world in making science-based decisions by acquiring data and subjecting data to rigorous statistical analysis. These data are painstakingly assembled through a long and laborious empirical drug discovery and development process, but even then under the best circumstances, our knowledge of drug-human interactions at the time of regulatory decision-making has been incomplete. This traditional process is ill suited for the new era of drug development based on molecular mechanisms, and it no longer provides a sound basis for making sound regulatory decisions.

In 2006, as we embarked on the FDA’s second 100 years and facing this new era in medicine, it was clear that the FDA had no other option but to undergo a revolutionary change and become a bridge (rather than a barrier) to innovation and productivity. This has been a project replete with difficulties, but essential for promoting the health of all Americans. We determined that the bridge must be securely anchored in a healthy debate that defines the preponderance of evidence for every regulatory decision. The structure, foundation, and supports of that bridge had to remain, as they had always been, a combination of statutes, science, and regulation, with scientific data determining the pathway. And we knew that to be stable and enduring, this regulatory pathway had to be rigorous, precise, transparent and predictable.

However, we were also aware that it must never be so rigid that it could not respond to change. It must be capable of renovation to strengthen the FDA’s ability to confront new challenges -- challenges brought about by such developments as modern methods of food production and distribution; the use of emerging techniques in molecular and cellular biology to develop and evaluate complex new drugs and biologics; the elucidation of regulatory pathways for complex and integrated bioengineered medical devices. A daunting task is the increasing globalization of the industries that produce FDA-regulated products.

Identifying the Challenges and Opportunities

As we began three years ago to establish the strategic and systematic priorities and initiatives for the FDA’s transformation, it was clear that the enormous task ahead could not be accomplished without overcoming our major obstacle: a dire need for adequate FDA resources, staffing and infrastructure. The agency’s funding had been stagnant for years; its workforce was aging with many eligible for retirement with no plan for replacements; facilities were dispersed; and the FDA’s information technology infrastructure was archaic and operated out of the stove-piped centers making it inaccessible to other agency employees.

While the need for greater resources was obvious to everyone at the agency, the case had to be made to others in the public health community. A disciplined assessment of some of FDA’s needs was already underway: a September 2006 report The Future of Drug Safety- - Promoting and Protecting the Health of the Public by the Institute of Medicine (IOM) of the National Academies of Science evaluated the FDA processes in depth, endorsed several new drug safety measures already adopted by the agency, but also made important recommendations for improvements. We addressed these suggestions by forming a task force that examined not only the FDA’s drug safety processes, but also operations across the entire agency that could further ensure medical product safety. Overall, our response to the IOM report facilitated our life cycle approach to product regulation: the building of safety into new products as well as monitoring their performance when used by patients.

We also took numerous other steps to reinvigorate the agency and better protect the health of our public. In January 2007 I asked the FDA Science Board -- a federal advisory committee of senior experts in evolving areas of science -- to convene a subcommittee for conducting a comprehensive review of the FDA’s scientific portfolio. Specifically, I asked the Board whether that portfolio is aligned with the emerging progress in science and technology that’s driving the discovery and development of new products, and to determine where there are gaps and unnecessary redundancies across the agency’s scientific work, and whether FDA’s scientific effort is appropriate for supporting our regulatory decision-making. I also asked the Board to help us define the unique contribution of our scientific effort to the larger research enterprise conducted by other government agencies, academic institutions, and industry and to identify opportunities for more effective collaboration and partnering with other scientific organizations.

Other initiatives were prompted by emerging concerns about food safety which lead to a comprehensive Food Protection Plan that became a corollary to the government-wide Import Safety Action Plan requested by President Bush. We also launched other, less well-publicized efforts such as a trans-agency strategic plan for the regulation of all products that could mitigate the impact of avian influenza, and we convened a Bioinformatics Board to create a master plan for a comprehensive overhaul of FDA’s information systems.

But our main early focus was on bolstering the medical product safety system in three basic ways:

 

  • By strengthening the science that supports the FDA's medical product safety system throughout the product life cycle, from pre-market testing and development through post-market surveillance and risk management. These measures have included developing new scientific approaches to detecting, understanding, predicting, and preventing adverse events; developing and incorporating new quantitative tools in the assessment of benefit and risk; and conducting a pilot program to review the safety profiles of certain newly approved drugs on a regularly scheduled basis.
  • By improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products. For example, we‘ve established an advisory committee to help improve the agency's risk communication policies and practices. We’re also assessing the utility of current public communication tools like webcasts and blogs and we’re developing a comprehensive strategic plan for risk communication.
  • And we’ve begun improving operations and management to ensure efficient review, analysis, consultation, and communication processes. As part of this project, we are engaging external management consultants to assist our Center for Drug Evaluation and Research in developing a comprehensive strategy for accelerating drug reviews and improving the evaluation of risk. This effort will result in specific organizational and management changes designed to increase communications among review and safety staff.

In addition, throughout 2007, FDA personnel worked with representatives of industry, the public and members of Congress on the formulation of the Food and Drug Administration Amendments Act (FDAAA), which was signed by President Bush in September 2007. The legislation was passed with bipartisan support in both the Senate and the House and represents an important addition to FDA’s authority, including the reauthorization of the user fee programs for drugs and medical devices. These user fees have provided the needed increased resources for our enhanced drug safety initiatives while adding flexibility for the FDA’s use of user-fee funding in implementing the total life cycle approach to drug regulation. This highly significant law also mandated the implementation of FDA’s initiatives that were responsive to the IOM Drug Safety report. FDA has already began implementing key provisions such as the requirement for post market studies and clinical trials, safety labeling changes, and Risk Evaluation and Mitigation Strategies (REMS). The new safety authorities in Title IX, Subtitle A of the Amendments Act took effect on March 25, 2008.

Another major event in fall 2007 was the release of the Science Board’s Subcommittee on Science and Technology report that I had requested. Entitled FDA Science and Mission at Risk, the panel identified existing significant gaps in science and technology in the following specific areas: systems biology, wireless health care devices, nanotechnology, medical imaging, robotics, cell and tissue based products, regenerative medicine, and combination products. It also emphasized the significant need for additional resources to enable the FDA to keep pace with the increasing scientific complexity of its regulatory obligations.

While these reports were helpful, it was apparent that the challenges facing the agency went far beyond addressing its scientific foundation or adequacy of its resources. The difficulties involved the cumbersome processes for decision making and the inadequacy of the historical model of regulation. This became especially clear when we evaluated the role played by inspections of products or facilities in assuring the products’ quality and safety. Inspections, which were successful in the 20th century, were proving to be woefully inadequate for the realities of a global supply chain and market of the 21st century -- and particularly this was the case with ensuring the safety of America’s vast imports of food produced all over the globe. To confront this unprecedented challenge, I created the position of Associate Commissioner of Food Protection and commissioned the development of a modern, more efficient food-protection strategy. The result was FDA’s science- and risk-based Food Protection Plan that’s focused on safeguarding food from contaminants through prevention, intervention, and response.

These internal and external reviews had a still more far-reaching impact by catalyzing systemic and systematic changes throughout the agency as described in the FDA Strategic Action Plan. Released in 2007, the Strategic Action Plan provides the blueprint and framework for the FDA’s modernization efforts. This Plan is based on these four goals that will enable FDA to attain maximum regulatory efficiency:

 

  • Strengthen FDA for Today and Tomorrow. The objectives are to upgrade FDA’s science base by establishing a fellowship program; enhance partnerships to improve information exchange with others in the public health community; and modernize our facilities and information technology.
  • Improve Patient and Consumer Safety. We will facilitate better-informed healthcare decisions by providing easier access to clear and timely risk-benefit data about medical products and faster information about food-borne outbreaks.
  • Increase Access to New Medical and Food Products by improving the predictability and transparency of medical product development and review; facilitating the availability of more nutritious and safe food products; and developing standards, guidances, and other tools to facilitate and encourage regulated product research and development.
  • Improve the Quality and Safety of Manufactured Products and the Supply Chain through the use of modern, science-based safety equipment; compliance with standards that ensure high-quality manufacturing, processing, and distribution of the regulated products; and upgrading our detection of safety problems and execution of targeted intervention.


Many of the initiatives toward these goals of the Strategic Action Plan are well underway but they must be sustained to be fully successful. Furthermore, we recognized that these initiatives could not take place in a vacuum. The FDA had to reach out to key partners in the private sector, federal government and in other countries to leverage our resources. One of our main efforts over the past three years has been to enhance communication with our stakeholders and formalize collaborations and partnerships. We’ve entered into formal Memoranda of Understanding with counterpart regulatory agencies abroad and with such domestic agencies as the Department of Defense and the Veteran’s Administration. We have enhanced interactions with Customs and Border Protection at the Department of Homeland Security, with the U.S. Department of Agriculture, and with the National Institutes of Health, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services. In addition, we’ve reached out to all 50 U.S. state agencies involved in health and agriculture and joined efforts with WebMD and Microsoft.

From the beginning, I took it for a given that the FDA’s structural and functional transformation will only succeed if it is anchored in the bedrock of a robust high-performing and value-driven workforce and a cultural environment that inspires our employees to make their best effort. To explore these customs and habits that grow out of a collective identity within the agency, we engaged in a months-long self-scrutiny through a series of focus groups. The result of this initiative was the development of the FDA Values and Vision Statement that expresses the spirit in which FDA pursues its mission. It embodies the following qualities:

  • Integrity-- uncompromising in, both professional and personal conduct;
  • Excellence—in maintaining world-class regulatory standards and performance;
  • Accountability—both collective and individual, for our performance;
  • Equity—honoring the dignity of each of us, without discrimination or harassment;
  • Diversity—in thought, beliefs, physical attributes and cultural background; and
  • Transparency—to merit trust in our decisions and processes.


The Values and Vision of FDA are influencing everything we do. We’re committed to programs of leadership development and training in management that includes mandatory 360-degree evaluations of managers to foster responsibility and accountability. We’re targeting our recruitment to expand the FDA’s intellectual capital in areas of expertise essential to regulate emerging state-of-the-art products. We’re focusing on processes that are critical to the mission of a science-based agency. This includes improvements in bio-informatics, information technology and Web initiatives; application of best business practices in administration; and development of an efficient process for review and promulgation of regulations and guidances. Finally, we’ve launched an internal and external communication program that has two objectives: to ensure wide and timely dissemination of public health information, and to facilitate a two-tiered, agency-wide system of scientific conflict resolution that fosters vigorous scientific debate and constructive dissent while maintaining the integrity and substance of our regulatory decisions.

Resources

The initial phase of FDA transformation began in 2007 with a focus on strategic planning serving as the foundation for the enhancement of the agency’s financial resources. Recognizing the need but, more importantly, having confidence in the emerging FDA strategy and plans, the President, the administration and Congress increased the agency’s appropriations for fiscal year (FY) 2008 by 13 percent, or $262.2 million, over the previous year. In addition President Bush, upon the recommendation of Secretary Leavitt, submitted to Congress an amendment of his proposed FY 2009 budget to include an additional $275 million for the agency. These increases raised the total proposed FDA budget for FY 2009 by $404.7 million – a 17.8 percent boost in funding from FY 2008 -- and reversed the trend that had kept FDA’s appropriations below the increases in the cost of living.

This very significant boost to our modernization efforts was complemented by new authorities vested in FDA by the Food and Drug Administration Amendments Act (FDAAA), which I’ve already mentioned. One FDAAA provision of importance to the long range success of the agency was the creation by Congress of the Reagan-Udall Foundation, whose job is to identify and address unmet scientific needs in the development, manufacture and evaluation of the safety and effectiveness of FDA-regulated products, including their post-market evaluation. , This is an independent 501(c) 3 organization whose members support the FDA mission by establishing advanced scientific projects and programs that contribute to the protection and promotion of the public health. The statute calls for a 14-member board: four representatives from the general pharmaceutical, device, food, cosmetic, and biotechnology industries; three from academic research organizations; two from patient or consumer advocacy groups; one representing health care providers; and four at-large representatives with expertise or experience relevant to the foundation's purpose. The FDA commissioner and NIH director participate in foundation activities as non-voting board members. Initially, the Board’s work was hampered by restrictions on its start-up funding, but it has successfully developed its processes for incorporation and committed to support two major programs, the FDA’s Fellowship Program and the Sentinel Initiative, a nationwide public-private effort to transform post market surveillance of the safety of drugs and medical products.

Workforce

In addition to helping improve the safety of imports, protect the food supply and ensure medical products are safe and effective, the additional resources provided in 2008 have enabled us to launch a vigorous recruitment effort to enhance the skills of the workforce essential for transforming the FDA. By the end of September 2008, FDA had surpassed its goal to hire 1300 talented people to address the agency’s critical needs, especially for more inspectors in the U.S. and abroad. This approximate 10-percent increase will be further augmented in the second phase of this hiring operation, with the target of 1400 additional staff. These vital newcomers to the FDA family will take up numerous needed roles, including consumer safety officers, chemists, microbiologists and medical officers, and will be dispersed across all FDA centers and offices. Equally important, the FDA has embarked on programs of staff retention through career development and an agency-wide assessment and adjustment of its performance-based and market-equitable compensation programs.

Perhaps most critical to the long range vitality intellectual environment of the FDA workforce has been the creation of the FDA Commissioner’s Fellowship Program, which is designed to bring to the agency the best and the brightest scientists and professionals from academia, industry, and other parts of the government. This two year mentored and curriculum-driven program is the cornerstone of the FDA’s personnel succession planning efforts. This autumn, FDA welcomed the first class of 50 FDA fellows -- biologists, chemists, physicians, microbiologists, epidemiologists, pharmacologists, biomedical engineers, general engineers, pharmacists, physicists, and veterinary medical scientists -- selected from over 1,000 applications received by the agency. Each fellow has been assigned to work on projects with preceptors throughout the agency. The new fellows, who hail from 16 states, will inevitably bring fresh ideas and new approaches to the way FDA does its work and their first-hand knowledge of the agency will serve as a foundation throughout their scientific careers. We are developing approaches that will give them an opportunity to continue those careers at the FDA.

IT Infrastructure

We’re also aware that to do their best, FDA leaders and employees need the most up-to-date tools and equipment. FDA can be viewed as an organization whose primary job is information management. Promoting and protecting the public health depends on FDA’s ability to acquire and analyze enormous quantities of data, whether in voluminous Investigational New Drug (IND) applications or the massive reporting of adverse events. We must then act on that analysis to make scientifically sound decisions, and then acquire still more data that continuously monitors the safety and effectiveness of marketed products. Without reliable and efficient data management, FDA cannot fulfill this core mission. Prior to 2005, FDA was spending approximately $200 million per year on information technology in hardware and software, but the system remained antiquated and fragmented. Computer network servers were inefficient and scattered throughout centers and offices without adequate support systems. Much of the equipment was inadequate for the demands of managing increasingly complex data sets. Data systems were unable to “talk to each other”—for example, people working in the regional field offices did not have access to data at the centers, and centers could not easily share information with each other.

This IT bottleneck was increasingly impairing the agency’s ability to monitor and regulate the development of medical products based on new science. We therefore initiated a comprehensive modernization of the entire IT infrastructure beginning with a systematic replacement of hardware, and including the creation of an efficient inter operable network of servers and a centralized data systems center. Equally important was to address the software programs that would support the conduct of the agency’s regulatory mission. We’ve created the FDA Bioinformatics Board whose members from each Center and operational unit oversee the upgrading of the agency’s IT system. Specifically, the Board’s job is to help develop a more highly automated scientific information environment focused on electronic data submissions, data mining and analysis, and design unified, agency-wide approaches to new system development in support of decision making. Numerous projects toward these ends are already underway.

One of them is Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting, or PREDICT, which is a prototype system intended to replace the admissibility screening portion of FDA’s current electronic system for processing import entries. PREDICT considers the health risks posed by the products themselves, and the likelihood that individual shipments are adulterated, misbranded, or otherwise in violation of the law. The greater the rate of automated "may proceeds" by the system for lower-risk products, the more time reviewers will have to evaluate each of the remaining lines. The violations detected are evaluated not just in terms of percentages, but also in terms of health significance.

White Oak

Collaboration, cooperation and cohesiveness are hallmarks of the interdependent nature of FDA’s components -- and yet physically, the FDA of the 20th century was highly fragmented with dozens of facilities scattered around the Washington DC area. When I arrived at the agency, this problem was already being addressed by the White Oak Consolidation Project which seeks to build an FDA campus whose important landmark -- the completion of Building One -- we today celebrate. The construction of modern infrastructure and facilities at this former site of the Navy Surface Weapons Laboratory (at White Oak in Silver Spring, Maryland) is essential for FDA’s growth in size and scope as well as enhancing the quality of life of employees.

Having employees within close proximity of one another should help the integration of FDA science, which is critical to the agency’s ability to maintain its preeminence as a science-based and science-led agency. In 2006, the White Oak architectural plan was revised to create an integrated campus with formal and informal spaces to foster interdisciplinary dialog and collaboration between FDA’s centers and offices. As of this month, seven of the campus’s 16 planned buildings are completed and occupied by more than 3000 relocated employees. Currently under construction are three buildings, a garage and access road. Design efforts are underway for a child-care center, another garage and three additional buildings. The facilities on this campus are already providing critical scientific capacity, with scientists working in modern laboratories equipped with the latest technologies and tools. By 2012, FDA will consolidate here 7700 employees from 20 different locations across the Washington, D.C. metropolitan area. But we can already foresee that because of the agency’s expanding responsibilities and mission, the campus will eventually need to accommodate 9000 employees.

For the past three years, we’ve also paid close attention to the needs of the FDA’s nation-wide facilities, and especially its field laboratories. As part of an extensive initiative called the “Revitalization of the Office of Regulatory Affairs,” we’ve developed programs and improved processes for the evaluation and upgrading of the offices and laboratory facilities that carry out the FDA’s critical public health work in every part of our country.

The Total Life Cycle Approach

Changes in programs and processes and enhancements in infrastructure have been accompanied by changes in policy. Again, the realities of a radically and rapidly changing world require new ways of thinking as well as doing. FDA can no longer be simply a gate-keeper assessing the benefits and risks before allowing a product to be made available to patients, or rely solely on inspections to verify safety.

FDA must engage in the total life cycle of the products it regulates, whether it is the food’s journey from farm to fork or a medication’s progress from its discovery to the patient’s bedside. Engaging in the discovery, development and delivery of regulated products will enable the FDA to better assure their quality and compliance with the public health laws and standards. This means working more effectively with product discoverers, developers and producers and using science-based risk management tools to build safety into products such that they meet regulatory requirements. And once the products reach the market, the Agency must use advanced technologies for effective surveillance to assure their safe and effective performance.
The “Critical Path” for product regulation

A key aspect of FDA’s engagement in the life cycle of health care products is the FDA Critical Path Initiative, a national effort to modernize the science through which FDA-regulated products are developed, evaluated, and manufactured. This Initiative’s goals include the development of a tool kit of projects and initiatives that will further strengthen FDA’s ability to make sound regulatory decisions about products and accelerate their availability to those who need them. Even more importantly, Critical Path is about obtaining more scientifically validated information about these medications and medical devices that will make predicting their performance more precise. It is also about managing the variability that patients experience in their response to products – allowing FDA to tailor its approval of treatments to those patients most likely to benefit from them, and to identify patients for whom they might pose an unacceptable risk. Whether the products are for personalized medicine or personalized nutrition, the Critical Path Initiative holds the promise of providing patients and consumers greater access to innovative products that are safe and effective for them.

The Sentinel Initiative

Another major new approach to greatly expanding our knowledge about the performance of medical products is the Sentinel Initiative, which we launched in 2008. This novel program, which involves both public and private sector partners, will create a nation-wide system that will enable the FDA to analyze information about widely-used medical products that’s collected in the huge databases of major healthcare systems. Instead of waiting for reports of adverse events to reach FDA, as we do today, Sentinel will eventually facilitate the FDA’s assessment of how large and diverse patient populations are affected by a medical product, whether side effects appear in combination with other medications, and whether dosing levels should be adjusted for particular cohort of patients.

Such advanced monitoring and detection must be accompanied by an enhanced FDA response to the identified adverse outcomes. We’re improving our capability for intervention by increasing risk-based inspections of products and facilities, using modern scientific tools for problem detection, and expanding our network or partnerships and collaborations designed to keep unsafe products off the United States market.

Globalization

We live in a world where borders may be boundaries, but they are not barriers. Borders don’t stop diseases or products that may harm us; and borders should not act as barriers to the products and processes that can protect us. Global production and a rapid international supply chain make us all interconnected and interdependent.

Today the flood of FDA-regulated imports into the United States is swelling each year: shipments of imported food have increased from 2.8 million in 1997 to 9.1 million last year, and shipments of other FDA-regulated products, primarily drug ingredients, have gone up during the same period more than 13-fold, from 550,000 to 7.2 million. Not only do these products move more rapidly, and arrive in ever-greater quantities, but their very nature has changed. Americans want choice and convenience, especially in the food we consume. We want fresh strawberries all year round and pre-packaged greens for our salads. Producers have responded by adopting new methodologies for food harvesting, processing and shipping. For example, today we can get cantaloupe out of season due to the advent of the “chiller.” When cantaloupes are picked on a hot day and then dropped into cold water; it dramatically increases their shelf life, but also increases the potential for bacterial contamination.

Finished drugs and medical devices are no longer “made” in any single country, but are assembled with components and ingredients from every corner of the globe. And the products FDA regulates are far more complex because of new technologies such as nanotechnology, and include highly complicated biologics, monoclonal antibodies, and genetically engineered plants and animals. All these innovations are creating new regulatory challenges for the FDA.

To respond to the increasingly global nature of the agency's regulation of food, medical products and cosmetics, we established in 2008 FDA’s first permanent offices outside the U.S. Our “Beyond Our Borders” initiative will facilitate FDA’s increased collaboration with foreign regulators, use of certified third parties to obtain information about industry compliance with the FDA’s regulatory standards, and direct engagement with manufacturers abroad at their production sites to build safety into regulated products rather than depending final inspections. Based on the volume and risks of imported products from specific areas, as well as the value to be derived from leveraging resources with counterpart regulatory authorities, we’ve identified China, India, the Middle East, Europe and Latin America as regions where we need to establish permanent posts. So far, FDA has established itself in three locations in China (Beijing, Shanghai, Guangzhou) and in Europe (Brussels, London and Parma in Italy), and we are in the process of posting staff in three locations in India (New Delhi, Mumbai, Hyderabad). In addition, we plan on expanding this overseas network of offices also to Costa Rica, Honduras, Mexico, Guatemala and South America and eventually in Jordan and Israel.

These in-country FDA offices are an integral part of this systems-based, comprehensive approach to the new challenges to the security of the U.S. from imported FDA-regulated products. The objective of these in-country offices is to help make the U.S. border only one of several integrated checkpoints (not “the” only checkpoint) to verify that imported products comply with U.S. health and safety requirements. The functions of these FDA offices abroad are both essential and manifold: they will enable FDA to gather better information about the manufacture of these products and their transport to U.S. ports; engage with trusted counterpart agencies to leverage scientific, inspectional, and other resources; help developing counterpart agencies build their capacity for enhancing the safety of regulated products exported from their countries; work with selected third parties to acquire reliable information about manufacturers’ compliance with FDA standards; engage with regulated industry to learn about its expectations for coming global activities; and perform more overseas inspections of higher risk facilities. Inspection by sophisticated and well equipped FDA personnel will always be integral to our protection of Americans, and it will continue to be a part of FDA’s much more comprehensive product safety and security system.

The Beyond Our Borders initiative focuses also on helping foreign regulators understand FDA standards. To help ensure compliance with FDA laws and regulations, FDA provides technical assistance to counterpart foreign regulators and to foreign industries that engage in trade with the U.S. to help them understand, and comply with, U.S. safety and other regulatory requirements. A significant proportion of the U.S.’ increased imports comes from developing countries whose authorities need information and expertise to help them oversee the production of safe and high quality FDA-regulated products for export to the U.S. By providing these agencies with technical assistance, the FDA aims to raise the confidence we can all have in these products.

These efforts complement more than 70 cooperative arrangements our agency has entered into over the years with its foreign counterparts. Most recently, under the leadership of Secretary Leavitt, the Department of the Health and Human services and the FDA signed two Memoranda of Agreement (MOA) with the People’s Republic of China. One of them is with China’s Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and its goal is to enhance the safety of food and feed imported into the U.S. from China. The second MOA is with China’s State Food and Drug Administration (SFDA) and it is designed to enhance the safety of drugs, excipients and medical devices that Chinese manufacturers export to the U.S. Both agreements are focused on registration and certification requirements, greater information sharing and increased access to production facilities for FDA inspectors.

The MOA with the Chinese State Food and Drug Administration for example, includes a provision for a registration program and the development of a system that will enable the Chinese government to certify the status of Chinese firms that manufacture active pharmaceutical ingredients (API) and other components of finished drug products. To support the Chinese registration program, and work toward a certification program, agencies from the two countries will conduct training programs and activities to cover topics such as inspection methods and clinical trials and will discuss each country’s development of relevant technical guidance documents, regulations, and laws.

Another component of the Beyond Our Borders initiative leverages private sector resources. As recommended in the President’s Action Plan for Import Safety, FDA is pursuing expanded use of third party certification to verify compliance with U.S. safety and security standards. These third parties can include foreign government agencies, state government agencies or independent entities that have been accredited by FDA. Such third-party certifications would complement FDA’s own inspectional and other regulatory activities by providing the agency with information about a firm’s compliance with FDA requirements, thereby helping the FDA in targeting its limited compliance and inspection resources.

Emergency Preparedness: Pandemic Influenza

In September of 2005, the FDA was faced with a global challenge: an acute risk of pandemic influenza. To counter this major public health hazard, the agency needed an integrated, comprehensive, and coordinated plan. In the event of a pandemic, every single component of the agency would need to be mobilized to perform urgent tasks ranging from the rapid dispersal of vaccines and antiviral drugs to ensuring adequate supply of medical devices such as respirators, and to assuring the safety of food and the safe disposal of infected animal carcasses.

This was an opportunity for FDA to break down its silos of individual response and embrace a coordinated strategy; to switch from the reactive mode of a regulator to the proactive actions of a facilitator. We immediately engaged with academia and industry to encourage the development and manufacture of the necessary medications and to help ensure their appropriate delivery in cooperation with the private sector and our federal, state, and international counterparts.

Fortunately, we did not have to face an outbreak but the benefit of these comprehensive, multi-disciplinary, integrated preparations has been the enhancement of our vaccine manufacturing capacity. Unlike three years ago, when we had only three licensed vaccine manufacturers of influenza vaccine in the U.S., we now have six licensed firms. As a result, the flu vaccine shortages we experienced a few short years ago are a thing of the past, and we now have excess capacity. In addition, in 2007, we licensed the first influenza vaccine against the h5N1 influenza virus. Today FDA’s Pandemic Influenza Preparedness Strategic Plan is a model for trans-agency program development.

Communication

Communication is critical to maintaining the public trust in the FDA. Yet the FDA communication infrastructure I found when I came to the agency was inadequate, reactive and outmoded. It was therefore necessary to restructure and refocus it by adopting modern techniques of information-sharing, such as the Internet.

One significant step to reinforce this critical FDA function as well as its transparency was the creation of the Risk Communication Advisory Committee (RCAC), which was proposed by the report of the Institute of Medicine and endorsed in the FDA Amendments Act. It is composed of 15 highly qualified individuals, mostly academicians, who were selected by an agency-wide group of employees who communicate with the public about regulated products. Several of the RCAC members are “audience experts” familiar with the perspectives of patients, consumers, and health care professionals, and the committee’s job is to help the FDA become more effective in helping people to understand and appropriately respond to FDA health messages.

In addition, FDA recently created a Communications Council to strengthen cross-Agency collaboration and consistency in communications. FDA eliminated the “FDA Consumer” magazine and redirected the resources to modernizing the FDA website. The revamping of FDA.gov is well underway and should result in a new, user friendly and easily navigable interface in mid 2009. In addition to its own employees, the FDA has reached out to other experts to expand the agency’s capacity for providing consumers with timely and reliable health information involving the FDA-regulated products. For example, the FDA has made arrangement to post such information on the Internet in collaboration with WebMD, and I’ve enjoyed recording weekly an “Andy’s Take” webcast to inform the public about my perspective on public health issues. I have been informing the agency staff about important agency developments in an e-mailed weekly column called “Commissioner’s Comments” and by participating in regular “town hall” meetings with the various FDA offices and centers. Recognizing the importance of the print and visual media, external communication has been expanded through media “brown bags,” an open forum with selected major media reporters and my visits to editorial boards to discuss Agency priorities and perspectives. In addition, we’ve expanded our outreach to the public health community by hosting periodic meetings with FDA’s stakeholders including advocacy groups and consumers and industry organizations.

Moreover, we’ve gone out of our way to assure the American public of FDA’s openness and transparency by significantly improving the selection of the members of the Advisory Committees, whose job is to provide, in a public setting, expert and independent scientific and technical advice on important regulatory issues. To enhance the agency’s decision-making, transparency and the public’s confidence and trust in these extremely helpful advisory panels, we announced in August of 2008 new policies that make changes in several areas: the circumstances under which the agency will consider issuing a waiver involving a member’s potential conflict of interest; the disclosure of information related to waivers on the FDA website; the posting on the FDA website of advisory committee briefing materials at least 48 hours before the committee meets; a provision for simultaneous voting by committee members to avoid any perception that persons voting sequentially are influenced by the votes that preceded theirs; clarification on when to convene advisory committee meetings; and the launch of a new, easily navigable FDA advisory committee website www.fda.gov/oc/advisory .

I am confident that these carefully designed improvements will help ensure that FDA is getting the highest quality scientific advice while preserving our public’s confidence in FDA’s advisory committees and regulatory decisions.

Conclusion

The past three years have been pivotal for the FDA’s transition from its 20th century posture to progress, innovation and policies that will ensure it continues in the 21st century as the world’s leading regulatory agency. This transition is crucial to protect and promote the health of every American but it tasks a stressed FDA with meeting its formidable daily responsibilities of the here and now while racing to prepare for the challenges and opportunities of tomorrow.

The changes at the FDA are sweeping and range from policies and strategies to processes and programs. I like to describe the organized turbulence that permeates our agency as “a revolutionary evolution.” For those inside the Agency, it may seem to have the radical nature of a revolution. For those outside the Agency, it may seem to have the pace of evolution. But, rapid and radical change is occurring. Its goals are defined and they will be achieved, but not without patience and perseverance. The initial investment of increased appropriations and expanded authorities has been made but it must be sustained. All of us must understand that for the FDA there will never be a magic finish to this laborious change, because the process of transformation, adaptation, and regeneration must be continuous and ever-evolving; because that is the nature of the world we live in and the products FDA regulates.

I take great satisfaction in knowing that today the FDA is stronger and more able than three years ago to carry out its historic mission, and the American people can be even more confident in FDA’s ability to protect and promote their health.