The problem. Regulatory agencies by definition serve a multitude of interests and constituencies. How can agencies preserve the autonomy required to exercise that mixed mandate in a political climate?
Grantee background. In the acknowledgements to Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton University Press, 2010), Daniel Carpenter's sweeping examination of the FDA's century-long balancing act at the nexus of government, public health and commercial interests, Carpenter offers a personal explanation for having taken up the subject. His "decades long fascination with regulation," he writes, "was formed from listening to two old men and a young woman."
One of the "old men" was a professor with whom he took a single business and government course his last semester at Georgetown University—Marver Bernstein, PhD, first dean of the Woodrow Wilson School at Princeton University, former president of Brandeis University and an expert on regulation. Carpenter has a vivid memory of Bernstein pounding the lectern as he "thundered home" his point that regulators, far from being "philosopher statesmen," were "complicated agents embedded in organizations."
The other old man was his maternal grandfather, Edward R. Krumbiegel, who served as health commissioner of Milwaukee from 1940 to 1973, ending his tenure when Carpenter, a Milwaukee native raised in Elk Rapids, Mich., was 5 years old.
The young woman was Carpenter's physician mother, Kathleen Krumbiegel Carpenter, MD, who practiced radiology until 2000.
Between her stories and his grandfather's reminiscences "about old battles won and lost," Carpenter learned that "public health was an endeavor not only of science but of politics in its best and worst aspects."
"I was kind of a political junkie as a kid," says Carpenter, "and to be honest, something of a Reagan youth at the time, though I'm not now."
He followed his passion for politics first to Georgetown, where he graduated with honors, then to the University of Chicago, where he completed his PhD in political science in 1996, and won the Harold D. Lasswell Award from the American Political Science Association for his dissertation, "The Evolution of Corporate Attachment and Administrative Capacity in Executive Departments, 1862–1932."
Only after he began his first academic appointment, as assistant professor of politics at Princeton, did the FDA catch his eye. "If you were to write a cultural history of the U.S. in the 20th century," Carpenter says, "you'd be doing yourself a big disservice if you left out the FDA. You'd want Elvis Presley in there, you'd want the sexual revolution, you'd want race relations, a whole set of things, but the way the FDA has affected everyday life is crucial."
First award from RWJF. In 1998, Carpenter was awarded a Robert Wood Johnson Foundation Scholars in Health Policy Research Program grant to pursue his FDA research, at the University of Michigan, where he examined the varying speeds with which different drugs are government approved. The fruit of his research, The Forging of Bureaucratic Autonomy: Networks, Reputations and Policy Innovation in Executive Agencies, 1862–1928 (2001), would win both the American Political Science Association's award for the best book on U.S. national policy and the International Political Science Association's prize for best book on public administration and public policy. The following year, Carpenter moved to Harvard University, where he is now Allie S. Freed Professor of Government and director of the Center for Political Studies.
Moving on to the Investigator Award. In 2003, he received an RWJF Investigator Award in Health Policy Research to probe more deeply into pharmaceutical policy at the FDA. The pursuit quickly broadened. "I began to think more about the historicity of the FDA, and the fact that the FDA has this ubiquitous cultural presence, along with a political, economic, scientific and medical presence. And yet not everybody has the same picture of it," he says.
Exposure to the work of historian Richard White, PhD, on identity and reputation, during a shared sabbatical year at Stanford University's Center for Advanced Study in the Behavioral Sciences, sparked fresh insights into the FDA's signal complexity. "I learned a lot from him about methods for studying and writing about the historical development of institutions and organizations," says Carpenter. "To think about a single model or single portrait of the FDA—the FDA always behaves this way, or always behaves that way—is just inaccurate."
He drew another crucial insight from University of Chicago sociologist Erving Goffman's "theory of identities with multiple audiences. Just the way an economist would say, 'Let's strip down life and look at it as a marketplace, or a game,' he would say, 'Let's look at life as a theatrical performance, where there are various audiences, and various faces and meanings and roles that you can play in front of audiences.'
"That may sound odd," Carpenter says. "But as I began to dig deeper and deeper into the FDA's archives and correspondence, I began to see a lot of that—different people with different perceptions of the FDA, and the FDA acting in ways that would help maintain that multiplicity of perceptions. I wouldn't say to keep everybody satisfied, but to keep a multidimensional coalition of support, or at least deference, together."
What became clear was that the FDA's reputation—the source and guarantor of its autonomy—was in fact "a multiple reputation among multiple audiences, and that made its job harder, because it could play tough with pharmaceutical companies, say, but sooner or later, patients would say, 'Well, we need these drugs and you need to exhibit a more flexible humanistic face, one of compassion, for people whose lives are affected by your decisions.'"
From the beginning, Carpenter believes, the agency was conscious of this multiplicity of constituencies. One of the ways it sought to establish credibility with all of them was by investing heavily in scientific capacity, creating a system for evaluation of drugs that has become the world standard.
"If you look at the history of modern science, and see the way that pharmaceutical companies are structured, and the way that universities run their clinical trials, even the statistics programs that people use-all these were in many ways shaped by the fact that people wanted to use these various things to develop drugs. And in order to develop drugs, you had to go through the FDA. So that gate-keeping power instantly became a methodological power, and also a cultural power, because anytime you were having a debate about a drug, whether it was the Pill or a cancer medicine or AIDS, you were having a debate about the FDA."
In a tour de force of explication and analysis, Carpenter examines the intricate politicking and continual recalibration of image that have shaped the agency through its roller-coaster history of public favor and disfavor, from the "avoidable tragedy" of the 107 deaths traced to Dr. Massengill's Elixir Sulfanilamide in 1937, which sped the passage of the Federal Food Drug and Cosmetic Act of 1938, to the recall of Vioxx in 2009, which reopened the debate about post-market evaluation of drugs. In each of the battles Carpenter examines, what comes across is the crucial role generations of largely unheralded civil servants played in creating and preserving the agency's reputation, and it should surprise no one that a black and white photograph of one of these "complicated agents embedded in organizations" appears on the book's cover.
The photo is of Frances Oldham Kelsey, PhD, a University of Chicago pharmacologist and professor who joined the FDA in 1960. It was Kelsey—who once described her job as being "to pick these new drug applications to pieces"—whose scrupulous, unhurried review of the William Merrell Company's application for approval to sell the sedative thalidomide, kept the drug off the market in the United States.
When her role in the containment of thalidomide was made public, Kelsey became a national hero-awarded the Distinguished Civilian Service Medal by John F. Kennedy in a White House ceremony, voted one of the country's 10 most admired women in a 1962 Gallup poll-but Carpenter points out that, in fact, Kelsey's behavior was not the exception but "characteristic" of her medical peers; the regulatory system simply worked as it was supposed to.
A few years later, when the backlogged Investigational New Drug division Kelsey headed came under attack for being too cautious, the agency reacted with characteristic pragmatism (or expediency), reassigning her to head a less politically vulnerable division. It was, Carpenter writes, a perfect demonstration of "how the Administration's organizational structure embodied a subtle but transformative politics of legitimacy"-appeasing the agency's critics while protecting its "sacred cow."
RWJF Perspective. "One of the important criteria for selecting investigators is the likelihood that their work will inform health policy," says Lori Melichar, PhD, RWJF director. "Equally important to being selected is the promise of the investigator's proposal to rejuvenate the field of health policy research by asking innovative questions, applying innovative frameworks and using innovative methods.