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
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).