3
Foster Adaptability and Alignment

There should be an unremitting effort to improve those health, education, and social security efforts, which have proved their value…. But good intent and high purpose are not enough; all such programs depend for their success upon efficient, responsible administration.

Dwight D. Eisenhower (1953)

RECOMMENDATION 2

Foster Adaptability and Alignment

To improve the public’s health and achieve the department’s goals, the secretary should align and focus the department on performance and encourage creative use of scientifically based approaches to meet new and enduring challenges.

  1. The heads of all department units should ensure that their activities and operations are aligned with the department’s vision, mission, and goals and marshal their resources to achieve them.

  2. The secretary should reduce directly reporting senior-level officials to a manageable number. Although secretarial management styles differ, a rigorous decision-making process for both policy and operations must be established, along with accountability for results.

  3. The secretary should ensure a more prominent and powerful role for the surgeon general, who, in addition to leading the Commissioned Corps, should be a strong advocate for the health of the American people and work actively to educate Americans on important health issues. The secretary should work with the President and Congress to establish a process for identifying surgeon



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3 Foster Adaptability and Alignment There should be an unremitting effort to improve those health, education, and social security efforts, which have proved their value. . . . But good intent and high purpose are not enough; all such programs depend for their success upon efficient, responsible administration. Dwight D. Eisenhower (1953) RECOMMENDATION 2 Foster Adaptability and Alignment To improve the public’s health and achieve the department’s goals, the secretary should align and focus the department on per- formance and encourage creative use of scientifically based ap- proaches to meet new and enduring challenges. The heads of all department units should ensure a. that their activities and operations are aligned with the department’s vision, mission, and goals and marshal their resources to achieve them. b. The secretary should reduce directly reporting senior-level officials to a manageable number. Al- though secretarial management styles differ, a rigorous decision-making process for both policy and operations must be established, along with accountability for results. c. The secretary should ensure a more prominent and powerful role for the surgeon general, who, in addition to leading the Commissioned Corps, should be a strong advocate for the health of the American people and work actively to educate Americans on important health issues. The secre- tary should work with the President and Con- gress to establish a process for identifying surgeon 55

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56 HHS IN THE 21ST CENTURY general candidates for Presidential appointment that gives high priority to qualifications and lead- ership, and Congress is strongly urged to consider a longer term for this office. d. The secretary should work with the President and Congress to establish a selection process for the department’s senior-level officials that pro- tects the scientific and administrative integrity of major departmental units, promotes progress to- ward departmental goals, and is based primarily on the candidates’ qualifications and experience. Congress again is strongly urged to consider longer terms for some of these officials— especially the directors of the National Institutes of Health (NIH) and the Centers for Disease Con- trol and Prevention (CDC), and the commissioner of the Food and Drug Administration (FDA)— which would provide critical continuity in the na- tion’s public health and scientific endeavors. e. The President should make timely appointments and Congress should expedite the confirmation process for key HHS officials, including the secre- tary, deputy secretary, surgeon general, and the heads of FDA and NIH. Secretarial appoint- ments, such as the director of CDC, also should be expedited. f. The secretary should ensure that all department health programs, including the reimbursement programs, reinforce public health priorities and strategies in order to provide a consistent frame- work for protecting the public from health risks, promoting health, preventing disease and disabil- ity, and providing health services for vulnerable populations in the most efficient, cost-effective ways. g. To maximize value in the health care system, the secretary must strengthen the scientific base and capabilities of the department and ensure that agencies’ research findings are shared depart- ment-wide and that current best evidence is used

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57 FOSTER ADAPTABILITY AND ALIGNMENT for departmental decision making, including the Centers for Medicare and Medicaid (CMS) reim- bursement policy. h. Congress should allocate sufficient, predictable funding for NIH, CDC, FDA, and the Agency for Healthcare Research and Quality (AHRQ) in or- der to preserve and enhance these agencies’ sci- entific missions. Congress should also establish a specific budget line for AHRQ that is independent of appropriations to other HHS agencies. i. To address the growing threat of food-borne ill- nesses, Congress should unify the U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspec- tion Service and the food safety activities of FDA within HHS and ensure provision of adequate re- sources for high-quality inspection, enforcement, and research. SCOPE OF THE CHALLENGES As the organization charged with primary responsibility for ensuring the health and well-being of Americans, HHS must keep pace with rapid advances in many fields—biomedical sciences, health care technologies, the organization of health care, information technologies, health and so- cial services research, and quality improvement. It also must keep abreast of emerging global threats to health, rising consumer expectations, and pressure for cost control and greater efficiency. As Chapter 2 shows, substantial evidence indicates problems in HHS’s structure and alignment. However, even with an optimal structure and admirable alignment across its many units, HHS would face an array of challenges that were unimaginable when the department was created in 1953. First, like any large American organization, it must adapt to new and overarching trends, including many described by the former comp- troller general: • the need to respond to terrorism and other threats to security, • a population marked by increasing diversity and older age, • an accelerating pace of advances in science and technology, • rapid evolution of information and communications technology,

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58 HHS IN THE 21ST CENTURY • new challenges and opportunities to maintain and improve qual- ity of life, • variable and diverse governmental tools and structures (Walker, 2003), and • the many serious and long-standing threats to health that may be resolved, in part, only through additional research. Second, globalization—the growing interdependence among enter- prises, economies, and governments—complicates any effort to improve or protect health, placing many risk factors beyond the department’s con- trol. For example, the globalization of the food supply has the potential to introduce a wide range of contaminants. Organisms that produce in- fectious diseases can now move rapidly through air travel and the movement of people across countries. Changing demographics, including high levels of immigration into the United States from every continent, introduce a greater range of health behavior and present cultural differ- ences that create communication and health education challenges. Third, the burdens imposed by disease and disability do not lend themselves to the equal or “fair” distribution of government protections that citizens influenced by almost a half century of advances in civil rights and consumer advocacy now expect. Some diseases of great sever- ity, prevalence, and emotional cost have as yet no known treatment, so their victims suffer disproportionately. Some populations are at greater risk of certain diseases or complications, so they too suffer more than others. Children, the mentally ill and developmentally disabled, and other vulnerable groups cannot readily advocate for better health care for themselves. And, access to care is not uniformly available nationwide, since health professionals generally gravitate to larger, more prosperous communities, leaving many rural and low-income communities under- served. Fourth and finally, HHS has an extraordinarily broad reach through- out the U.S. health care system and many types of relationships: • Through its payment programs, HHS exerts regulatory influence over virtually all acute care hospitals, most physician practices, and many other health care providers. It affects more than 80 million Medicare and Medicaid beneficiaries (U.S. Census Bu- reau, 2008) and influences the flow of health information they receive.

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59 FOSTER ADAPTABILITY AND ALIGNMENT • Through grants and contracts, HHS relates to health departments in every state and territory and to the nation’s 2,800 local health departments (NACCHO, 2006). • Through service, research, and payment programs, HHS re- sponds to hundreds of organizations advocating for people with low incomes or who have specific diseases or disabilities and their families, children in Head Start, and the elderly who need meals at home or supportive services. • Through its operation of over 700 health facilities, HHS provides a vital source of health care to American Indians and Alaska Na- tives, groups who suffer disproportionately from the burden of chronic disease. • Through regulation, HHS reaches the manufacturers and suppli- ers of pharmaceuticals and medical devices, food processors and cosmetics manufacturers, and health care providers and profes- sionals of all kinds and in all localities. • Through its research agenda, HHS supports the nation’s bio- medical and health research community, health insurers, and health plans. • Finally, through its funding for health professions training, HHS interacts with the medical schools and other health professions educational programs that represent the future health care work- force. In short, HHS is an integral and central figure in a technology- intensive sector that now makes up nearly one-sixth of the nation’s econ- omy (Catlin et al., 2008), which continues to grow rapidly, and that vi- tally concerns every individual, family, employer, and community in the nation. HHS must be able to adapt to changing circumstances in a timely manner, take an active part in reforms of the health system, and solve problems creatively, using solid evidence and sound science. AN IMPROVED ALIGNMENT Alignment, or unification of strategy and activities throughout an or- ganization, has become extraordinarily important in progressive parts of the private sector, infusing employees of large firms with a sense of common purpose and a common approach to the future. Alignment also has been working its way into some parts of the public sector, such as the

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60 HHS IN THE 21ST CENTURY Department of Defense. HHS should go further in embracing this con- cept across its health and human services agencies. When programs are uncoordinated or operate at cross-purposes, less value is obtained. It will not be possible to align all department activities with the rec- ommended small number of goals, owing to agencies’ and programs’ existing responsibilities and commitments, many of which are congres- sionally mandated. However, a concerted effort should be made, espe- cially within the department’s major units, to evaluate their current missions, goals, responsibilities, and available resources to ensure that, insofar as possible, they are aligned with the department’s overarching vision, mission, and goals. Related Recommendation a. The heads of all department units should ensure that their activities and operations are aligned with the department’s vision, mission, and goals and marshal their resources to achieve them. LIMIT THE NUMBER OF PEOPLE REPORTING TO THE SECRETARY Many of this report’s recommendations begin with “The secretary” not because the committee believes that every decision should emanate from the secretary’s office, but simply because the person in that position bears ultimate responsibility for departmental operations. While the sec- retary needs a good rapport with the President, in addition to strong lead- ership and management skills, the committee places equal importance on the need for these skills among agency heads, who also must possess strong scientific and technical expertise and be able to work as a team led and coordinated, through some internal arrangement, by the secretary’s office. Currently, 30 official positions report directly to the secretary (HHS, 2008). These positions are as powerfully endowed as the administrator of the Centers for Medicare and Medicaid Services, which is responsible for 85 percent of all HHS expenditures, and as narrowly focused as the di- rector of the Center for Faith-Based and Community Initiatives. The sur-

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61 FOSTER ADAPTABILITY AND ALIGNMENT geon general is not among those who report directly to the secretary and possibly should be. Management theory and research generally suggest that the larger the organization, the fewer the number of people who should report directly to its chief executive officer (Hattrup and Kleiner, 1993). With such a wide a span of control, the secretary has little time to work with indi- viduals on their plans for new and existing programs, implementing strategies, or improving operations. The secretary’s role should be to concentrate on major emerging problems, or controversies, and on a handful of major initiatives, such as health reform, on the department’s budget and key appointments, and to serve as “ambassador” for the de- partment to other cabinet agencies, Congress, and the private health sec- tor. To create a new level of senior officials—including perhaps an un- dersecretary, powerful assistant secretaries, or some other configura- tion—might require congressional approval, but would follow the norm of other cabinet-level departments. HHS now has no undersecretary; by contrast, most departments have about three. While the committee en- dorses the need for streamlined reporting to the secretary, it does not make recommendations about specific configurations of positions and responsibilities, noting that such choices may be a matter of style or preference. To illustrate how such officials could possibly be deployed: • A subcabinet-level position could be created for each of HHS’s four main “business lines”: reimbursement, regulation, research, and direct services provision. The difficulty with the business lines approach is that many agencies are deeply involved in some combination of these activities. However, there are advantages in clustering agencies by their primary function. • Such an official could oversee cross-cutting departmental func- tions around policy, operations, information technology, com- munications, and budget. • A subcabinet-level official could oversee all of the agencies of the Public Health Service (PHS), whose functions should com- plement and reinforce each other. This would have the advantage of bringing more coherence to the various agencies. This model was used for a number of years when the assistant secretary for health (ASH) oversaw these agencies. • A subcabinet-level official could oversee cross-department ac- tivities, envisioned in Recommendation 5.

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62 HHS IN THE 21ST CENTURY • Alternatively, the department’s major health-related line func- tions, including key agency heads (such as NIH, FDA, CDC, CMS) and the surgeon general, could report directly to the secre- tary, while other agency heads and staff functions could report to a single subordinate, such as the deputy secretary. Having a smaller number of senior subcabinet-level officials report- ing directly to the secretary would enable better management and coordi- nation of agency directors, aid in the development of cross-cutting policies, facilitate collaboration, and ensure consistency (alignment) across agencies, while allowing individual agency directors to focus on their agency responsibilities and pay less attention to political pressures. While day-to-day operations could be managed by a new senior official (or officials), agency heads should, of course, always have direct access to the secretary for major policy decisions, budget planning, and in times of crisis. The committee also recognized a number of disadvantages to this approach, strongest among them that it could dissuade some talented individuals from accepting appointment to high-profile and influential posts—such as the directorships of FDA, NIH, and CDC—if it moved them a level down the chain of command and limited direct access to the secretary. The scope of responsibilities of the agency heads would re- main the same with this streamlined approach, but the coherence of agency activities to the department’s mission would be enhanced. Tal- ented and experienced individuals will be attracted to top HHS positions because of their confidence in the leadership and direction of the depart- ment. The committee recognizes—and recent experience indicates—that individual secretaries will have different management styles and that some will want to centralize management in their office, while others will rely more heavily on subcabinet officials, such as an ASH, to man- age the department. There are instances in which both styles have worked well. In either case, secretaries generally should encourage initia- tive and creativity at the program level. Often the best ideas come from the agency heads who are most deeply involved in the specifics of their unit’s work. Whatever internal configuration is chosen for the secretary’s office, the objective should be to encourage feedback loops across departmental units, so that they communicate with and learn more readily from each other, can align policies and programs more effectively, and work toward common goals. Whether that coordination rests with one or two people in

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63 FOSTER ADAPTABILITY AND ALIGNMENT the secretary’s office or by closer collaboration among a larger group of senior officials, it needs to happen. Similarly, regardless of the secretary’s management style, it is essen- tial that there be in place a process for making policy and operational decisions that is rigorous, so that decisions are made based on the best evidence; clear, so that the department’s many agencies and programs can stay in alignment; and efficient, so that the processes are not redun- dant and that decisions are responsive and timely. This process includes consideration of how the organization will be accountable for the results of the decision and how it will measure or evaluate the decision’s results. Related Recommendation b. The secretary should reduce directly reporting senior-level officials to a manageable number. Al- though secretarial management styles differ, a rigorous decision-making process for both policy and operations must be established, along with accountability for results. AN EMPOWERED SURGEON GENERAL Americans have learned to look to, and trust, the U.S. surgeon gen- eral for impartial, scientifically valid information about health risks and health improvement: • In 1964 Surgeon General Luther L. Terry issued the landmark report declaring smoking hazardous to health. • In the 1970s Surgeon General Julius B. Richmond advanced childhood immunizations and many other health promotion and disease prevention measures. • In the 1980s Surgeon General C. Everett Koop, living up to his iconic status as a “straight talker,” demanded greater attention to HIV/AIDS. • In the 1990s Surgeon General David Satcher advocated action to provide mental health parity, reduce health disparities, and end discrimination based on sexual orientation, and reinvigorated the campaign to control tobacco.

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64 HHS IN THE 21ST CENTURY Since the Office of Surgeon General was established in 1871, only 17 individuals have held the office on a permanent (not “acting”) basis. The surgeon general holds the three-star rank of vice admiral, reports to the ASH, and serves a four-year term, which can be renewed for a sec- ond term. Since the expiration of Richard Carmona’s four-year term in July 2006, the United States has not had a permanent surgeon general. The surgeon general also oversees the operation of the 6,000 public health professionals in the Commissioned Corps of the Public Health Service, who serve in full-time capacities in agencies and programs throughout the federal government. Commissioned Corps members are available around the clock to meet public health emergencies anywhere in the United States and, sometimes, the world. Because of the emer- gency nature of these assignments, the surgeon general must have a smoothly operating management structure and good communication with the ASH, the assistant secretary for preparedness and response, and other HHS agencies involved in emergency response, in order to enable rapid mobilization. 1 The President appoints the surgeon general, subject to Senate con- firmation, and on occasion these appointments have proved controver- sial. Surgeon General Joycelyn Elders held an expansive view of sex education, which made her a lightning rod for criticism and led to her exit from office (Elders, 1996). After Surgeon General Richard Carmona left office, he accused the administration of silencing him on embryonic stem cell research, abstinence-only sex education, contraception, climate change, prison health, and mental health, and discouraging him from supporting the Special Olympics (Harris, 2007). In July 2007 testimony before the House Committee on Oversight and Government Reform, former Surgeon General C. Everett Koop said that, when working on his report on HIV/AIDS and a subsequent mailer, he and the secretary had to maintain strict secrecy throughout the proc- ess. If they had “followed protocol and had every word scrutinized by the secretary’s secretariat,” he said, “these reports, because of their nature and plain speaking, would not have seen the light of day” (Koop, 2007). Although the nation’s senior health advocate should speak with discre- tion, the surgeon general should be free to openly discuss important 1 In recent years, the surgeon general has deployed these well-trained individuals to re- spond to the terrorist attacks of 9/11 and to natural disasters, including Hurricanes Katrina and Rita and the Indian Ocean tsunami, where they provided medical and public health services and humanitarian assistance.

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65 FOSTER ADAPTABILITY AND ALIGNMENT health topics and educate the public on evidence-based prevention and health promotion strategies. To ensure the independence of this uniquely trusted office—and the politically unfettered advocacy for improved health of the American peo- ple—the surgeon general should not be subject to an appointment proc- ess influenced by partisan pressures. 2 Alternatives to help guarantee the surgeon general’s independent voice include the following: • Establish the custom that a prestigious committee oriented to science and health would identify and review candidates and recommend a panel of three or four highly qualified candidates, from which the President could choose (similar to the appoint- ment process for the undersecretary for health in the Department of Veterans Affairs; the process, specified in law [38 USC §305], also stipulates that the appointment should be “without regard to political affiliation or activity”). • Establish a tradition that such a committee would authoritatively evaluate the President’s choice of a prospective surgeon gen- eral’s credentials before the appointment is sent to the Senate. • Secure bipartisanship support prior to an appointment, for exam- ple, by consultation with the chair and ranking member of the Senate Committee on Health, Education, Labor, and Pensions. These types of processes would respond to most of the reforms rec- ommended by a recent National Academies committee as ways to ensure the best science and technology appointments for government by ad- dressing the need to attract the best leadership; make appointments speedily; provide continuity; improve the process by which candidates are nominated, cleared, and confirmed; and broaden the pool of potential candidates (NRC, 2008). Such processes could be equally well employed in filling other top departmental positions, such as those discussed in the next section. 2 The role of the surgeon general has been taken up by some members of the 110th Congress, including proposed legislation that would strengthen the role of the surgeon general as America’s health advocate (the Surgeon General Restoration Authority Act [S. 1777] and the Surgeon General Independence Act [H.R. 3447]).

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76 HHS IN THE 21ST CENTURY Related Recommendation To maximize value in the health care system, the g. secretary must strengthen the scientific base and capabilities of the department and ensure that agencies’ research findings are shared depart- ment-wide and that current best evidence is used for departmental decision making, including the CMS reimbursement policy. STABILIZED RESEARCH FUNDING Scientific research projects typically extend well beyond a single fis- cal year. Predictability in funding is important, and delays in budget ap- provals can be especially injurious to the large, multiyear, multi- institutional, multidisciplinary projects that now distinguish scientific inquiry (IOM, 2003), from which so much has been learned about dis- ease risk factors and treatments (NHLBI, 2007). HHS’s use of, and support for, science can be impeded by uncertain- ties about the department’s annual budget, especially during extended congressional consideration. For example, the 2009 HHS budget appears unlikely to be adopted until February 2009, with the government operat- ing under a continuing resolution bill enacted in September 2008. Under previous continuing resolutions, NIH has given investigators with ongo- ing projects 80 percent of their approved budgets for the continuing reso- lution period, typically a few months. Unfortunately, when a budget is delayed until over a third of the fiscal year has elapsed, this can have a significant impact on research funding. Because of the below-inflation percentage increase in the 2009 proposed President’s budget for NIH, if the agency is funded at that level, it may be forced to award fewer grants in fiscal year 2010 (Bhattacharjee et al., 2008). Budget delays—and any perception that HHS is a less-than- hospitable environment for scientists—compound difficulties in recruit- ing and retaining the quality and quantity of scientists needed to support agency missions—whether in the biomedical sciences, social sciences, biostatistics and epidemiology, or health services research. Budgets of HHS science agencies have fluctuated greatly in recent years. NIH and CDC experienced large increases after 2000 (see Figure 1-3 in Chapter 1) and then saw little growth or experienced actual reduc-

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77 FOSTER ADAPTABILITY AND ALIGNMENT tions in funding. Multiyear budget planning for these vital agencies would be helpful. Serious concerns also have been raised about the ade- quacy of funding of HHS science agencies, with the news media report- ing that recent budget cuts threaten gains in the public’s health (Fox, 2008; Harris, 2008; Trapp, 2008). Since 2002, AHRQ has not had its own separate budget allocation, but receives funds from other PHS agencies through a PHS evaluation set-aside. This has left the agency’s budget an order-of-magnitude smaller than every other major PHS agency except FDA, whose budget is still five times that of AHRQ. 6 AHRQ’s mission is to support, con- duct, and disseminate research that improves access to care and the out- comes, quality, cost, and utilization of health care services—in other words, to increase the value of the health care services Americans re- ceive. Research projects in AHRQ’s diverse portfolio investigate nearly every aspect of the U.S. health care system, and AHRQ works with both the public and the private sectors to conduct and sponsor research and translate its research findings into improved clinical practice. The agency also attempts to refine decision-making techniques and practices, such as comparative effectiveness studies and evidence-based medicine. To make progress in developing and applying critical analytic tools to today’s health care organization, delivery, and financing challenges, AHRQ requires a more reliable and viable funding stream. Giving AHRQ an independent budget, adequate to its task, is essential to achiev- ing the accountability and the value-based health system the committee envisions. Related Recommendation h. Congress should allocate sufficient, predictable funding for NIH, CDC, FDA, and AHRQ in order to preserve and enhance these agencies’ scientific missions. Congress should also establish a specific budget line for AHRQ that is independent of ap- propriations to other HHS agencies. 6 In 2007, the program level budget for AHRQ was $319 million and for FDA just over $2 billion.

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78 HHS IN THE 21ST CENTURY A FORTIFIED STRUCTURE OF FOOD SAFETY REGULATION There are many opportunities for reorganization within HHS—and indeed across federal departments—that would bring more coherence, reduce overlaps and redundancy, and create more efficiency. Changes of this sort can be extremely difficult, time consuming, and highly contro- versial. They involve obtaining new authorizing legislation, the reas- signment of large budgets and significant numbers of people, the opposition of powerful special interest groups, both expected and unex- pected disruptions in work, and other implementation difficulties. Crea- tion of the new Department of Homeland Security was a case in point: Only at a time when Congress and the nation felt a sense of severe crisis could such a massive reorganization have occurred so swiftly, but even with that utmost sense of urgency, the transition was far from smooth. For these reasons, the IOM committee so far has avoided suggesting the reorganization of agencies within HHS or across departments. How- ever, the seriousness of the food safety issue prompted the committee to use it as an example of a public health issue that HHS cannot address adequately within its current structure, which is the reason some reorganization would be both logical and advantageous, despite the difficulties. Proposed consolidation of the food safety activities of FDA and the USDA’s Food Safety and Inspection Service (FSIS) is not merely illustrative, however, since its potential to benefit the health of the American public is so great that it is included among the committee’s recommendations. 7 Nowhere is the weakness of HHS’s science base more apparent or potentially harmful than in FDA’s food safety regulatory activities. A candid report recently prepared for the FDA Science Board found (FDA Subcommittee on Science and Technology, 2007): The nation’s food supply is at risk. Crisis management in FDA’s two food safety centers, Center for Food Safety and Applied Nutrition and Center for Veterinary Medi- 7 Food safety issues have garnered a great deal of attention in Congress. A search for bills in the 110th Congress related to “food safety” returns over 100, with some calling for improved coordination and unification of the food safety inspection activities (e.g., H.R. 2297 and H.R. 7143), which the Senate Committee on Governmental Affairs con- cluded was necessary over 30 years ago when it called for a single food safety agency (Senate Committee on Governmental Affairs, 1977).

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79 FOSTER ADAPTABILITY AND ALIGNMENT cine, has drawn attention and resources away from FDA’s ability to develop the science base and infrastruc- ture needed to efficiently support innovation in the food industry, provide effective routine surveillance, and con- duct emergency outbreak investigation activities to pro- tect the food supply. FDA’s inability to keep up with scientific advances means that American lives are at risk. 8 [Emphasis added.] In part, this state of affairs reflects deficits in both the number and the expertise of FDA’s scientific workforce: “[D]espite the significant increase in workload during the past two decades, in 2007 the number of appropriated personnel remained essentially the same—resulting in ma- jor gaps of scientific expertise in key areas.… The turnover rate in FDA science staff in key scientific areas is twice that of other government agencies” (FDA Subcommittee on Science and Technology, 2007). In fact, in the past three years, one-fifth of the science staff and 600 inspec- tors have left FDA’s Center for Food Safety and Applied Nutrition (TFAH, 2008). Within the department, the organization of food safety responsibili- ties and information technology infrastructure is inadequate (FDA Sub- committee on Science and Technology, 2007). There are three separately managed components of FDA with major food safety responsibilities— the Center for Food Safety and Applied Nutrition, the Center for Veteri- nary Medicine, and the Office of Regulatory Affairs, which oversees FDA’s field force and controls the majority of the agency’s food safety resources. FDA has established an assistant commissioner for foods “to provide advice and counsel to the Commissioner on strategic and sub- stantive food safety and food defense matters” (FDA, 2007a). However, there is no FDA official whose full-time job is food safety and who has line and budget authority over the three food safety operating compo- nents. Moreover, monitoring any food-related outbreaks that occur—the 8 The Subcommittee on Science and Technology concluded that “science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” The report indicates that the science base of the entire agency is lacking, not just in the area of food safety, and is in need of reinforcement (FDA Subcommittee on Science and Technology, 2007). A discussion earlier in this chapter calls for a strengthened science base for HHS, includ- ing FDA.

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80 HHS IN THE 21ST CENTURY vital food safety epidemiology function—is managed and operated by CDC. Ensuring the safety of the food supply is an expanding—and visi- ble—governmental responsibility. 9 In the era of globalization, when the United States increasingly uses foreign sources for raw and processed foods, contamination of food sources has become much more common. Sixty percent of the fresh fruits and vegetables and 75 percent of the sea- food that Americans consume is imported, but FDA inspects only an es- timated one percent of these imports (TFAH, 2008), and some analysts estimate that tests for U.S.-produced foods dropped nearly 75 percent between 2003 and 2006 (Bridges, 2007). Bacteria and other potentially injurious organisms are transported easily across the nation or between countries in containers or through human travel; chemical contamination can occur in processing, storage, or transport, especially in nations with lax inspection systems. These problems have been illustrated in recent, widely publicized outbreaks of food-borne illnesses, such as the 2008 Salmonella outbreak, involving imported raw jalapeño and serrano peppers, which affected some 1,400 individuals (CDC, 2008). What the Government Accountability Office has called “the patch- work nature of the federal oversight of food safety” compromises the federal government’s ability to keep up with fast-evolving food safety challenges (GAO, 2007). Food regulation is diffused across at least 12 agencies, including FDA, USDA’s FSIS, the National Marine Fisheries Service of the Commerce Department, the Environmental Protection Agency (regulating pesticides) (IOM, 1998), and the Department of Homeland Security (coordinating federal food security activities). Costly duplication and potentially dangerous inconsistencies result, affecting such jointly regulated aspects as importation facilities (GAO, 2007). As one of many examples of costly duplication and inefficiency, USDA and FDA inspect different types of imported food, but they do not share resources. USDA officials are present every day in import inspec- tion facilities, many of which also receive and store FDA-regulated products. But FDA inspectors appear less frequently, so foods often “re- 9 The USDA, which is responsible only for meat, poultry, and processed egg products, spends twice as much on food safety as does FDA, which is responsible for all other foodstuffs. USDA’s FSIS has a budget of more than $1 billion (USDA, 2008a) and a workforce of more than 9,000 (USDA, 2008b), many of whom are deployed at inspection sites around the country.

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81 FOSTER ADAPTABILITY AND ALIGNMENT main at the facilities for some time,” since USDA has no jurisdiction over them (Walker, 2007). Although many agencies are involved in food safety, none “has ulti- mate authority or responsibility, so accountability for the total system is limited. No one person in the federal government has the oversight and accountability for carrying out comprehensive, preventive strategies for reducing food-borne illness” (TFAH, 2008). Further, FDA’s food safety authority, like its authority over drugs, was constructed decades ago and does not reflect current manufacturing and distribution processes (IOM, 2007). The system remains ill equipped to meet emerging challenges—as an Institute of Medicine (IOM) report concluded a decade ago (IOM, 1998), even before the terrorist events of 2001 heightened concerns about the security of our food supply. Con- gress should assess the large collection of food safety laws regulating various commodities to determine whether they should be updated and coordinated, in light of an evolving industry, improved science for de- tecting hazards, trends in contamination, and globalization of food prod- ucts and ingredients. The goal should be to mount a public health- oriented regulatory program that not only would prevent food-borne ill- nesses, but also would make rational use of federal food safety resources. Because of shortcomings and gaps in the existing regulatory struc- ture, the IOM committee recommends uniting the food safety responsi- bilities of the two largest agencies involved—FDA and FSIS—within HHS, as the most appropriate locus for comprehensive regulation. The committee considered other alternatives including maintaining the cur- rent division of responsibility or uniting food safety responsibilities within FSIS. The recent and problematic food safety issues described in this chapter strongly indicate the need for strengthening our ability to monitor the safety of our food supply. The committee believed that the problems cannot be solved within the current structures. There are at least five major reasons for the choice of unifying food safety responsi- bilities within HHS: 1. The department is dedicated solely to protecting the public, in contrast to USDA, which has additional, industry-fostering pur- poses, and it is important to immunize food safety regulation from potential undue industry influence. 2. The department is oriented to disease prevention, health promo- tion, and public health generally. Placing food safety responsi- bilities within HHS could more effectively link those functions

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82 HHS IN THE 21ST CENTURY to the overall mission of the department. For example, within HHS, food inspection functions would be closer to the surveil- lance functions carried out by the CDC. 3. The Committee recognizes the strengths of the FSIS program and the scientific expertise it provides (currently, FDA relies on USDA for much of the science base of food safety regulation). A thoughtful and careful transfer of FSIS functions to HHS and its multiple science-based resources could enhance the capability to more effectively coordinate the use of science to enhance food safety. 4. HHS has full regulatory authority over drugs, and the distinction between foods and drugs is diminishing. We have the advent of “nutriceuticals” and greater acceptance of “health foods” and supplements, and foods are increasingly exposed to antibiotics, irradiation, pesticides, and other chemical interventions, as well as genetic modification. 5. Recognizing the need to strengthen its food safety regulatory op- erations, FDA recently developed a Food Protection Plan, an in- tegrated strategy to protect the food supply through prevention, intervention, and response (FDA, 2007b). The IOM committee understands that transferring FSIS functions to the department is likely to be difficult and that similar proposals in the past have been met with resistance: • It would be a large move, in both budgetary and personnel terms. • Major revisions to authorizing legislation for FSIS would be needed. • It would weaken the voice of public health within USDA— obviating the need for the position of USDA undersecretary for food safety, who is currently required by law to have food safety or public health credentials. • Without additional action, it would sever the food regulatory re- sponsibility from its research base. For the unification to be effective, it therefore would have to include provisions for (1) ongoing collaboration or relocation of USDA food safety research programs to HHS, and (2) maintaining relationships with USDA programs that work to prevent food contaminations on farms.

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83 FOSTER ADAPTABILITY AND ALIGNMENT Bringing FSIS—and closer ties to USDA’s science programs—into HHS would strengthen U.S. food safety efforts overall. Finally, because drug regulation so dominates the current FDA, 10 the committee was not persuaded that the unified food safety function should be lodged automatically within that agency. Creation of a new, focused food safety entity might be preferable. In any case, the advantages to the public of unifying food safety regulatory authority within a health- focused department far exceed the disadvantages. The nation no longer should have to rely on excessively compartmentalized, fragmented, and inconsistent regulatory procedures to ensure that the food Americans eat is safe for human consumption. Related Recommendation To address the growing threat of food-borne ill- i. nesses, Congress should unify the USDA’s Food Safety and Inspection Service and the food safety activities of FDA within HHS and ensure provi- sion of adequate resources for high-quality in- spection, enforcement, and research. REFERENCES Bhattacharjee, Y., J. Kaiser, E. Kintisch, A. Lawler, and J. Mervis. 2008. U.S. science faces a flat 2009. ScienceNOW September 29. Boufford, J., and P. Lee. 2001. Health policies for the 21st century: Challenges and recommendations for the U.S. Department of Health and Human Ser- vices. New York: Milbank Memorial Fund. Bridges, A. 2007. Food safety. Associated Press Archive February 26. Catlin, A., C. Cowan, M. Hartman, S. Heffler, and the National Health Expendi- ture Accounts Team. 2008. National health spending in 2006: A year of change for prescription drugs. Health Affairs 27(1):14-29. CDC (Centers for Disease Control and Prevention). 1993. Perspectives in dis- ease prevention and health promotion final results: Medicare influenza vac- 10 Internally, the ratio of FDA’s budget spent on food, compared to that spent on human drugs, has shrunk markedly—from 0.89:1 in 2000 to 0.73:1 in 2009 (FDA, 2008). (That is, in 2000, for every dollar spent on human drugs, the agency spent 89 cents on food safety; in 2009, though budgets for both activities have increased, it spent only 73 cents on food safety for every dollar spent on drugs.)

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