12 Aug Pub Admin Wk 4
· Review “Day One” in Chapter 8. The President of the U.S. gets 100 days to prove himself. However, it is unlikely Jacqueline Gibson will get that much time. Gibson needs to take charge quickly and effectively during this critical career transition period. Discuss one or two specific strategies she might follow and actions she might take.
· Jacqueline Gibson drove down Freeport Boulevard, accelerating once in a while to beat a signal. It was a crisp afternoon with just enough snap in the air to make life seem simple and sweet, if you didn’t have too much on your mind. Jackie did.
· She reviewed recent events. Two weeks ago the governor’s office had notified her of her appointment to the position of Undersecretary of Environmental Protection, Water Resources, for the state of California. The water resources division that she would lead was responsible for ensuring that (a) rivers, lakes, estuaries, and marine waters are fish-able and swimmable; and (b) groundwater is safe for drinking. In addition to these responsibilities, the water resources division was charged with (c) the engineering and construction of dams, pipeline transportation of freshwater, and the collection of all water revenues from the various cities and towns in the state; and (d) overseeing sewage disposal and marine transportation. The position involved the supervision of the division’s three sections and the 990 persons who were assigned to it.
· This morning, Monday, November 9, 2002, she had arrived at the state office building and went to the water resources division on the fourth floor. There she introduced herself to the greeter and was ushered into her new office, a government-green room trimmed in dark wood. The greeter told her that the secretary of environmental protection had arranged for her to meet the other undersecretaries at 9:15 A.M.
· At the designated time she went to the Golden State Conference Room on the first floor where seven people were assembled around a magnificent black lacquered table. They all rose as she entered, and the secretary, a vigorous, elfin man, introduced her to the five other undersecretaries and the deputy secretary of the department, Gilberto Sanchez. All sat down and one by one the undersecretaries briefed her about what their divisions did. Jacqueline then spoke about her expectations for good working relations with them. At about 10:00 A.M., the secretary adjourned the meeting and exited, smiling warmly at her.
· She then returned to her office and began looking for the files her successor had left. Surprisingly, there were none. How could that be, given the division’s broad responsibilities? Later that morning, she noticed the undersecretary of the air resources division walking briskly by her open door without looking in. Around noon, she went out alone for a salad and did some errands.
· She returned to her office around 1:30 p.m. and with her assistant began ordering and organizing supplies. Checking her e-mail, she found nothing of particular significance, nor were there any items requiring immediate action. At 2:45, she began meeting with her three directors individually. Each informed her deferentially that “everything was under control.” No meeting lasted more than ten minutes. Around 3:45, the deputy secretary walked by her office, glanced in, and asked how things were going. “Fine, Gilberto,” she said. “Won’t you come in?” He stepped into her office, welcomed her once again to the department, and excused himself to get back to a meeting from which he had just stepped out.
· Jacqueline returned to her desk and wondered whimsically whether she should start stacking her paper clips. Although she did not know exactly what working for state government would be like, she felt she was familiar enough with the issues. She had an undergraduate degree in marine biology plus an MPA, had done extensive volunteer work for the Natural Resources Defense Council, and had known professionally the secretary of environmental protection for several years.
· As she eased her car onto the Capital City Freeway, she made a decision: This evening, if she did anything, she would develop a road-map for becoming the leader of the state water resources division.
· Using the Government accountability office, discuss how the leadership is promoting change to the field of public administration. Justify your response with one or two examples.
· Using the e-Activity and the government accountability office, find a current event from the past two years and discuss the administrative responsibility to the stakeholders, organization, and public regarding the issues in described in the current event. Justify your response with one or two examples.
· Review “The FDA Task Force” in Chapter 4. The author of the case study states: “Even though at least 60 percent of Americans disapprove of cloned food, the FDA in 2006 ruled that milk and meat from cloned animals should be allowed on grocery store shelves.” As an FDA Administrator, explain how you would respond to the public’s objections of the “respected colleague” about the use of control groups. In your response, identify and explain which principles you applied. Provide one or two examples to support your response.
THE FDA TASK FORCE
The Food and Drug Administration (FDA) is one of the nation’s oldest and most respected consumer protection agencies. Stated simply, the FDA’s mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way and monitoring products for continued safety after they are in use.
The FDA is expected to regulate annually $1.5 trillion in food, drugs, vaccines, medical devices, blood and tissues, radiation-emitting machines, animal feeds and drugs, cell phones, dietary supplements, biotechnology and gene therapy—and, post 9/11, to uncover any food-borne terrorist plot. Yet the agency’s annual funding, $2 billion, is only about what Fairfax County, Virginia, pays for its public schools. And despite mounting concerns about the safety of Chinese-made drugs, the agency had only enough field inspectors in 2008 to check a mere 13 of the 714 Chinese factories that produce medicines for U.S. consumers.
Industry dollars now pay for more than half of the FDA’s drug-review budget; in five years, that proportion is expected to jump to 70 percent. Called user fees, this $400 million a year is designed to speed decisions on applications for new drugs and save taxpayers money. But some critics maintain that they undermine public confidence in the FDA’s independence and impose time pressures that could end up costing lives.
Assume you have been appointed to a task force to review “Guidelines on Good Clinical Practice in FDA-Related Clinical Trials.” To test the efficacy of promising new drugs, current regulations require that pharmaceutical companies conduct trials with two groups of people. The first group, the treatment group, consists of at least 300 people with the condition the drug is designed to alleviate—for example, high blood pressure. The second group, the control group, consists of another 300 people as similar to the first group as possible with respect to age, sex, vital signs, and of course the condition. The first group receives the new drug, while the second group receives a placebo. At the end of a one-year trial, the progress of each group is measured. If there is a significant statistical difference in the progress of the first group over that of the second group—and no serious side effects occur—the drug is approved.
During one task force meeting a respected colleague makes the following remarks: “Look, I’m all for the scientific method. But how can we in good conscience literally assign some people to death? I thought we were supposed to be helping people— not killing them.”
Somewhat puzzled, you ask your colleague to clarify.
“O.K.,” he continues, “Suppose the wizards at some company come up with a potent new drug that lowers cholesterol. Preliminary research on animals suggests that the drug is not only safe but much more effective than other available drugs. Now suppose we have this 70-year-old woman. Let’s call her Lucy. Her cholesterol level puts her at risk of a heart attack. And Lucy is taking care of her husband with cancer. But in this trial she only has a 50–50 chance of getting the drug. It seems that there’s got to be a better way to run clinical trials and promote health.”
One of the great challenges in public administration is ensuring that the actions of government agencies like the FDA are consistent with the wishes of citizens. Presumably, legislators and chief executives—elected and reelected by the people—ensure that consistency. Yet, given the complexity of twenty-first-century government, it seems impossible to avoid delegating large amounts of power to unelected civil servants to use at their discretion. In a famous 1940 essay, Carl J. Friedrich argued that the public administrators’ own concern for the public interest was often the only assurance that administrative actions were responsive to the electorate’s wishes. Herman Finer disagreed: To maintain responsiveness, public administrators should be subject to strict and rigid control by the legislature. “The political and administrative history of all ages has,” he wrote, “demonstrated without the shadow of a doubt that sooner or later there is an abuse of power when external punitive controls are lacking.” Who’s position—Friedrich’s or Finer’s—do you find more persuasive?
How would you respond to the objections of the “respected colleague” about the use of control groups? In formulating your answer, what principles are you applying? What other ethical issues might the FDA face? Would you apply those same principles in the same way to these issues that you did with the control group issue? If you can’t think of any other ethical dilemmas, try this one. Even though at least 60 percent of Americans disapprove of cloned food, the FDA in 2006 ruled that milk and meat from cloned animals should be allowed on grocery store shelves.