Campus & Community

Prying the lid off the FDA:

6 min read

Daniel Carpenter investigates one of America’s least understood bureaucracies

Daniel Carpenter: ‘The crucial thing driving the FDA is safeguarding its reputation. It takes a long time with approvals because it doesn’t want to make visible mistakes.’ (Staff photo by Jon Chase)

Why does the Food and Drug Administration (FDA) take longer to approve asthma medicines than arthritis medicines?

The reason, Daniel Carpenter explains, has to do with the socioeconomic profiles of the two groups of victims. Asthma sufferers tend to be poorer, younger, inner city dwellers who lack political clout. Arthritis sufferers as a rule are older, and elderly Americans have more money and are more politically active.

Even though asthma is responsible for more deaths and more hospitalizations than arthritis in the United States, the greater political influence of arthritis sufferers prompts the federal bureaucracy to work more expeditiously on their behalf.

“Why give one drug priority over another?” asks Carpenter. “Well, the FDA has limited resources and they must make choices. What happens is that the better organized and more newsworthy patients tend to get quicker results.”

Carpenter, who was appointed this year to a tenured position in the Government Department, has spent many years conducting a large scale study of the FDA that looks carefully at the agency’s history, its inner dynamics, and its impact on the pharmaceutical industry and on public health. His ongoing book project, “Guardian of Credence: Pharmaceutical Regulation at the FDA” presents the results of his in-depth research.

“There are a lot of opinion pieces and policy reports written about the FDA, but very few of them are based on rigorous theory or empirical analysis. My aim was to correct that.”

Carpenter’s colleagues in the Government Department have been impressed by the scope and insight of his work on the FDA, as well as by his earlier work on the origins of American bureaucracies, “The Forging of Bureaucratic Autonomy: Reputations, Networks, and Policy Innovation in Executive Agencies, 1862-1928” (Princeton University Press, 2001).

“Dan Carpenter has a brilliant, wide-ranging mind, and brings a remarkable range of skills to the study of American political development and regulatory politics,” said Theda Skocpol, the Victor S. Thomas Professor of Government and of Sociology. “His book, ‘The Forging of Bureaucratic Autonomy,’ offers a breathtaking overview of the origins of federal administrative bureaucracies and develops an original theory of the conditions under which government officials can establish capacities for independent policy innovation. The theory can be applied far beyond the period he studies, even far beyond the U.S. case itself.”

Skocpol adds that as a colleague and teacher, Carpenter “has brought a blast of fresh air to the Government Department. He has organized a regular lunch for faculty and students to discuss the study of institutions. He engages students and colleagues in invigorating discussion of his work and theirs. A warm and supportive colleague to all, he also challenges everyone to think harder and better.”

Regarding his FDA study, Carpenter points out that his work is intended as an objective look at the agency, not an exposé. Not all his findings have been negative.

The FDA, which was given its gatekeeping power over new drugs by the Food, Drug and Cosmetic Act of 1938, came into being at a time when the market was flooded by patent medicines claiming to be effective against everything from cancer to diabetes to gout. In actuality, about 95 percent of them were of no clinical or medical benefit. By eliminating a large portion of these ineffective drugs, the FDA has helped to maintain consumer confidence, which Carpenter contends is the agency’s primary goal.

“The crucial thing driving the FDA is safeguarding its reputation. It takes a long time with approvals because it doesn’t want to make visible mistakes. If people begin to doubt that the FDA is getting it right, their confidence will erode.”

Carpenter compares the FDA’s gatekeeping function to the safety regulations that govern the airline industry. The point of that branch of federal regulation is not simply to save lives but to maintain confidence in flying and to prevent consumers from abandoning the airlines in favor of other forms of transportation.

Similarly, explains Carpenter, “if physicians lose confidence in new drugs, they’re not going to prescribe them as much. They’ll stick with the old ones, or they’ll opt for surgical treatments.”

Carpenter disputes charges by some critics that the FDA expedites the approval process according to how big the market for a given drug is expected to be.

“If that were the case, the FDA should have approved Viagra or Celebrex 20 to 50 times faster than a drug like Gleevec [a breakthrough treatment for chronic myaloid leukemia, a relatively rare disorder]. The blockbuster drugs would get the quickest approval, while lifesaving drugs for small populations would get the slowest approval – and that’s not the case.”

In fact, Carpenter’s study, reported in the July 2002 issue of the American Journal of Political Science, has shown that drugs for diseases that involve greater hospitalization time tend to be approved more quickly.

“At some level, I was glad to find that,” he says. “It’s reassuring that drugs for more serious diseases get approved more quickly, in the sense that the FDA is giving greater attention and resources to more severe and more costly medical conditions.”

Carpenter’s interest in the FDA grows out of a more general interest in how government bureaucracies work, a field of study that he says has been neglected in recent years. Interestingly, his focus on the nitty-gritty of government evolved out of a far more theoretical concern. As a beginning graduate student at the University of Chicago he studied political philosophy, reading seminal thinkers like Weber, Hegel, and Plato.

“One of my great triumphs is that I received a ‘high pass’ [the highest grade possible at the time] in the University of Chicago’s classical Greek exam. I’m very proud of that,” he says.

It has been some time since Carpenter has found classical Greek to be a useful scholarly tool. As he started working on his Ph.D. dissertation, he began to turn toward empirical study as a way of examining the wider issues of the state and the proper functions of government.

This focus led him to examine the origins and growth of federal bureaucracies in America, the basis of his dissertation and his first book. The FDA study seemed like a natural outgrowth of this investigation because it is one of the few federal agencies that directly decides whether or not a product can be placed on the market.

“I was drawn more toward studying contemporary bureaucracies as a way of answering these broader questions. Some guy sitting in Rockville, Maryland, deciding whether a drug gets approved – now that’s the power of the state!”

Carpenter earned his A.B. degree from Georgetown University in 1989. He received his A.M. degree from the University of Chicago in 1991 with a thesis titled “Plato’s Gorgias and Democratic Rhetoric.” He earned his Ph.D. from the University of Chicago in 1996. Before coming to Harvard, he taught at Princeton University and the University of Michigan.