Week 4 Discussion

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.

Source: Philip J. Hilts, Protecting America's Health: The FDA, Business, and One Hundred

Years of Regulation (New York: Alfred E. Knopf, 2003).