Download and read online Reputation and Power in PDF and EPUB The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints. 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.
Download and read online The Routledge Handbook of Libertarianism in PDF and EPUB Libertarians often bill their theory as an alternative to both the traditional Left and Right. The Routledge Handbook of Libertarianism helps readers fully examine this alternative without preaching it to them, exploring the contours of libertarian (sometimes also called classical liberal) thinking on justice, institutions, interpersonal ethics, government, and political economy. The 31 chapters--all written specifically for this volume--are organized into five parts. Part I asks, what should libertarianism learn from other theories of justice, and what should defenders of other theories of justice learn from libertarianism? Part II asks, what are some of the deepest problems facing libertarian theories? Part III asks, what is the right way to think about property rights and the market? Part IV asks, how should we think about the state? Finally, part V asks, how well (or badly) can libertarianism deal with some of the major policy challenges of our day, such as immigration, trade, religion in politics, and paternalism in a free market. Among the Handbook's chapters are those from critics who write about what they believe libertarians get right as well as others from leading libertarian theorists who identify what they think libertarians get wrong. As a whole, the Handbook provides a comprehensive, clear-eyed look at what libertarianism has been and could be, and why it matters.
Download and read online Building the Judiciary in PDF and EPUB How did the federal judiciary transcend early limitations to become a powerful institution of American governance? How did the Supreme Court move from political irrelevance to political centrality? Building the Judiciary uncovers the causes and consequences of judicial institution-building in the United States from the commencement of the new government in 1789 through the close of the twentieth century. Explaining why and how the federal judiciary became an independent, autonomous, and powerful political institution, Justin Crowe moves away from the notion that the judiciary is exceptional in the scheme of American politics, illustrating instead how it is subject to the same architectonic politics as other political institutions. Arguing that judicial institution-building is fundamentally based on a series of contested questions regarding institutional design and delegation, Crowe develops a theory to explain why political actors seek to build the judiciary and the conditions under which they are successful. He both demonstrates how the motivations of institution-builders ranged from substantive policy to partisan and electoral politics to judicial performance, and details how reform was often provoked by substantial changes in the political universe or transformational entrepreneurship by political leaders. Embedding case studies of landmark institution-building episodes within a contextual understanding of each era under consideration, Crowe presents a historically rich narrative that offers analytically grounded explanations for why judicial institution-building was pursued, how it was accomplished, and what--in the broader scheme of American constitutional democracy--it achieved.
Download and read online Pharmaceutical Freedom in PDF and EPUB If a competent adult refuses medical treatment, physicians and public officials must respect her decision. Coercive medical paternalism is a clear violation of the doctrine of informed consent, which protects patients' rights to make medical decisions even if a patient's choice endangers her health. The same reasons for rejecting medical paternalism in the doctor's office are also reasons to reject medical paternalism at the pharmacy, yet coercive medical paternalism persists in the form of premarket approval policies and prescription requirements for pharmaceuticals. In Pharmaceutical Freedom Jessica Flanigan defends patients' rights of self-medication. Flanigan argues that public officials should certify drugs instead of enforcing prohibitive pharmaceutical policies that disrespect people's rights to make intimate medical decisions and prevent patients from accessing potentially beneficial new therapies. This argument has revisionary implications for important and timely debates about medical paternalism, recreational drug legalization, human enhancement, prescription drug prices, physician assisted suicide, and pharmaceutical marketing. The need for reform is especially urgent as medical treatment becomes increasingly personalized and patients advocate for the right to try. The doctrine of informed consent revolutionized medicine in the twentieth century by empowering patients to make treatment decisions. Rights of self-medication are the next step.
Download and read online The Forging of Bureaucratic Autonomy in PDF and EPUB Until now political scientists have devoted little attention to the origins of American bureaucracy and the relationship between bureaucratic and interest group politics. In this pioneering book, Daniel Carpenter contributes to our understanding of institutions by presenting a unified study of bureaucratic autonomy in democratic regimes. He focuses on the emergence of bureaucratic policy innovation in the United States during the Progressive Era, asking why the Post Office Department and the Department of Agriculture became politically independent authors of new policy and why the Interior Department did not. To explain these developments, Carpenter offers a new theory of bureaucratic autonomy grounded in organization theory, rational choice models, and network concepts. According to the author, bureaucracies with unique goals achieve autonomy when their middle-level officials establish reputations among diverse coalitions for effectively providing unique services. These coalitions enable agencies to resist political control and make it costly for politicians to ignore the agencies' ideas. Carpenter assesses his argument through a highly innovative combination of historical narratives, statistical analyses, counterfactuals, and carefully structured policy comparisons. Along the way, he reinterprets the rise of national food and drug regulation, Comstockery and the Progressive anti-vice movement, the emergence of American conservation policy, the ascent of the farm lobby, the creation of postal savings banks and free rural mail delivery, and even the congressional Cannon Revolt of 1910.
Download and read online Preventing Regulatory Capture in PDF and EPUB Leading scholars from across the social sciences present empirical evidence that the obstacle of regulatory capture is more surmountable than previously thought.
Download and read online The Warping of Government Work in PDF and EPUB The divergent paths of public and private employment have intensified a long-standing pattern: elite workers spurn public jobs, while less skilled workers cling to government work as a refuge from a harsh private economy. "The Warping of Government Work" documents government s isolation from the rest of the American economy and arrays the stark choices we confront for narrowing, or accommodating, the divide between public and private work."
Download and read online Countering the Problem of Falsified and Substandard Drugs in PDF and EPUB The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Download and read online Biologics A History of Agents Made From Living Organisms in the Twentieth Century in PDF and EPUB The use of biologics – drugs made from living organisms – has raised specific scientific, industrial, medical and legal issues. The essays contained in this collection each deal with a case study of a biologic substance, or group of biologics, and its use during the twentieth century.
Download and read online Conflict of Interest in Medical Research Education and Practice in PDF and EPUB Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
Download and read online Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad in PDF and EPUB A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.
Download and read online Edible Insects in PDF and EPUB Edible insects have always been a part of human diets, but in some societies there remains a degree of disdain and disgust for their consumption. Insects offer a significant opportunity to merge traditional knowledge and modern science to improve human food security worldwide. This publication describes the contribution of insects to food security and examines future prospects for raising insects at a commercial scale to improve food and feed production, diversify diets, and support livelihoods in both developing and developed countries. Edible insects are a promising alternative to the conventional production of meat, either for direct human consumption or for indirect use as feedstock. This publication will boost awareness of the many valuable roles that insects play in sustaining nature and human life, and it will stimulate debate on the expansion of the use of insects as food and feed.
Download and read online The Ethics of Dissent in PDF and EPUB From “constructive contributors” to “deviant destroyers,” government guerrillas work clandestinely against the wishes of their superiors. These many public servants are dissatisfied with the actions of the organizations for which they work, but often choose not to go public with their concerns. In The Ethics of Dissent: Managing Guerrilla Government, Second Edition, Rosemary O’Leary shows that the majority of guerrilla government cases are the manifestation of inevitable tensions between bureaucracy and democracy, which yield immense ethical and organizational challenges that all public managers must learn to navigate. Alongside updates to her original cases, O’Leary offers a new case on Private Bradley Manning and the WikiLeaks scandal, as well as new mini-stories for her Interlude sections.
Download and read online Hot Flat and Crowded 2 0 in PDF and EPUB A New York Times Book Review Notable Book of the Year A Washington Post Best Book of the Year A Businessweek Best Business Book of the Year A Chicago Tribune Best Book of the Year In this brilliant, essential book, Pulitzer Prize-winning author Thomas L. Friedman speaks to America's urgent need for national renewal and explains how a green revolution can bring about both a sustainable environment and a sustainable America. Friedman explains how global warming, rapidly growing populations, and the expansion of the world's middle class through globalization have produced a dangerously unstable planet--one that is "hot, flat, and crowded." In this Release 2.0 edition, he also shows how the very habits that led us to ravage the natural world led to the meltdown of the financial markets and the Great Recession. The challenge of a sustainable way of life presents the United States with an opportunity not only to rebuild its economy, but to lead the world in radically innovating toward cleaner energy. And it could inspire Americans to something we haven't seen in a long time--nation-building in America--by summoning the intelligence, creativity, and concern for the common good that are our greatest national resources. Hot, Flat, and Crowded is classic Thomas L. Friedman: fearless, incisive, forward-looking, and rich in surprising common sense about the challenge--and the promise--of the future.
Download and read online The Case against Perfection in PDF and EPUB