The U.S. Food and Drug Administration (FDA) is one of the world’s most powerful regulatory agencies. No new drug can be marketed legally in the United States unless the FDA declares it to be “safe and effective” for its intended uses. Having set the scientific standards and processes for drug approval, the FDA has played a key role in the industry’s evolution worldwide and shapes how pharmaceutical companies develop, market, and manufacture their products. More subtly, the FDA undergirds public confidence in pharmaceuticals.

According to Daniel Carpenter, the Allie S. Freed Professor of Government and Director of the Center of American Political Studies at Harvard University, the primary source of the agency’s power is its professional and scientific reputation, carefully cultivated over time and guarded by FDA career officials.

But how did the FDA’s reputation invest it with so much influence? And how exactly does the FDA wield its extraordinary power? Carpenter has probed these and other intriguing questions about the FDA’s history, evolution and behavior, more deeply perhaps than any other scholar ever.

Carpenter traces the roots of his interest in the curious and sometimes troubled intermingling of regulation, power, and politics to his grandfather, Edward Krumbiegel, who served for 33 years as health commissioner for the city of Milwaukee, Wisconsin. The stories he heard from his grandfather and from his mother, Kathleen, who worked as a radiologist, about battles over fluoridation, pest control, and other public health issues led him to understand early on that health policy does not emerge purely or even largely from the world of science. “I learned that public health was an endeavor not only of science, but of politics in its best and worst aspects,” Carpenter says.

"A marvelous collection of ideas and insights by first-rate scholars. This book lays a foundation for more creative and effective policy-making." - Stephen M. Shortell, Dean and Blue Cross of California Professor of Health Policy and Management, University of California, Berkeley

Health care delivery in the United States is an enormously complex enterprise, and its $1.6 trillion annual expenditures involve a host of competing interests. While arguably the nation offers among the most technologically advanced medical care in the world, the American system consistently under performs relative to its resources. Gaps in financing and service delivery pose major barriers to improving health, reducing disparities, achieving universal insurance coverage, enhancing quality, controlling costs, and meeting the needs of patients and families.

Bringing together twenty-five of the nation's leading experts in health care policy and public health, this book provides a much-needed perspective on how our health care system evolved, why we face the challenges that we do, and why reform is so difficult to achieve. The essays tackle tough issues including: socioeconomic disadvantage, tobacco, obesity, gun violence, insurance gaps, the rationing of services, the power of special interests, medical errors, and the nursing shortage.

Linking the nation's health problems to larger political, cultural, and philosophical contexts, Policy Challenges in Modern Health Care offers a compelling look at where we stand and where we need to be headed.

Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today.

Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested.

Daniel P. Carpenter is the Allie S. Freed Professor of Government at Harvard University. He is the author of The Forging of Bureaucratic Autonomy: Reputations, Networks, and Policy Innovation in Executive Agencies, 1862-1928 (Princeton).

Endorsements:

"Reputation and Power is by far the most thorough and penetrating study of the most powerful and important regulatory agency in the world--the U.S. Food and Drug Administration--and one of the best studies of any American regulatory agency. The book is essential reading for anyone seriously interested in American politics, public policy, administrative institutions, or health and medicine. This is an extraordinary work."--Paul Quirk, University of British Columbia

In Democracy Remixed, award-winning scholar Cathy J. Cohen offers an authoritative and empirically powerful analysis of the state of black youth in America today. Utilizing the results from the Black Youth Project, a groundbreaking nationwide survey, Cohen focuses on what young Black Americans actually experience and think--and underscores the political repercussions. Featuring their stories from cities across the country, she reveals that black youth want, in large part, what most Americans want--a good job, a fulfilling life, safety, respect, and equality. But while this generation shares much in common with the rest of America, they also believe that equality does not yet exist, at least not in their lives. Many believe that they are treated as second-class citizens. Moreover, for many the future seems bleak when they look at their neighborhoods, their schools, and even their own lives and choices. Through their words, these young people provide a complex and balanced picture of the intersection of opportunity and discrimination in their lives.

The political alienation and hope of black youth is real--and it is grounded in a contradictory reality that must be addressed. Democracy Remixed provides the insight and information necessary to truly transform the future of young Black Americans and American democracy.

New York. London. Paris. Although these cities have similar sociodemographic characteristics, including income inequalities and ethnic diversity, they have vastly different health systems and services. This book compares the three and considers lessons that can be applied to current and future debates about urban health care.

Highlighting the importance of a national policy for city health systems, the authors use well—established indicators and comparable data sources to shed light on urban health policy and practice. Their detailed comparison of the three city health systems and the national policy regimes in which they function provides information about access to health care in the developed world's largest cities.

The authors first review the current literature on comparative analysis of health systems and offer a brief overview of the public health infrastructure in each city. Later chapters illustrate how timely and appropriate disease prevention, primary care, and specialty health care services can help cities control such problems as premature mortality and heart disease.

In providing empirical comparisons of access to care in these three health systems, the authors refute inaccurate claims about health care outside of the United States.

"Rothman and Blumenthal's compelling book, Medical Professionalism in the New Information Age, fills a current gap in the literature on the possible implications of information technology for practicing physicians, health care organizations, and the profession more generally, thereby advancing both policy analysis and clinical practice."—Melissa Goldstein, George Washington University Medical Center

Description:

With computerized health information receiving unprecedented government support, a group of health policy scholars analyze the intricate legal, social, and professional implications of the new technology. These essays explore how Health Information Technology (HIT) may alter relationships between physicians and patients, physicians and other providers, and physicians and their home institutions. Patient use of web-based information may undermine the traditional information monopoly that physicians have long enjoyed. New IT systems may increase physicians’ legal liability and heighten expectations about transparency. Case studies on kidney transplants and maternity practices reveal the unanticipated effects, positive and negative, of patient uses of the new technology. An independent HIT profession may emerge, bringing another organized interest into the medical arena. Taken together, these investigations cast new light on the challenges and opportunities presented by HIT.

About the Editors:

DAVID J. ROTHMAN is president of the Institute on Medicine as a Profession (IMAP) and Bernard Schoenberg Professor of Social Medicine at Columbia College of Physicians & Surgeons. His many books include Strangers at the Bedside and The Pursuit of Perfection with Sheila M. Rothman.