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.

A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands

The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, "Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand "explores this increasingly important field to help readers understand what they can--and must--do to get the most out of their brands.

Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future.

While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. "Pharmaceutical Lifecycle Management" walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation.

Bioprospecting--the exchange of plants for corporate promises of royalties or community development assistance--has been lauded as a way to develop new medicines while offering southern nations and indigenous communities an incentive to preserve their rich biodiversity. But can pharmaceutical profits really advance conservation and indigenous rights? How much should companies pay and to whom? Who stands to gain and lose? The first anthropological study of the practices mobilized in the name and in the shadow of bioprospecting, this book takes us into the unexpected sites where Mexican scientists and American companies venture looking for medicinal plants and local knowledge.

Cori Hayden tracks bioprospecting's contentious new promise--and the contradictory activities generated in its name. Focusing on a contract involving Mexico's National Autonomous University, Hayden examines the practices through which researchers, plant vendors, rural collectors, indigenous cooperatives, and other actors put prospecting to work. By paying unique attention to scientific research, she provides a key to understanding which people and plants are included in the promise of "selling biodiversity to save it"--and which are not. And she considers the consequences of linking scientific research and rural "enfranchisement" to the logics of intellectual property.

Roving across UN protocols, botanical collecting histories, Mexican nationalist agendas, neoliberal property regimes, and North-South relations, "When Nature Goes Public" charts the myriad, emergent publics that drive and contest the global market in biodiversity and its futures.

This searing indictment, David HealyOCOs most comprehensive and forceful argument against the pharmaceuticalization of medicine, tackles problems in health care that are leading to a growing number of deaths and disabilities. Healy, who was the first to draw attention to the now well-publicized suicide-inducing side effects of many anti-depressants, attributes our current state of affairs to three key factors: product rather than process patents on drugs, the classification of certain drugs as prescription-only, and industry-controlled drug trials. These developments have tied the survival of pharmaceutical companies to the development of blockbuster drugs, so that they must overhype benefits and deny real hazards. Healy further explains why these trends have basically ended the possibility of universal health care in the United States and elsewhere around the world. He concludes with suggestions for reform of our currently corrupted evidence-based medical system.

The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including:

• Standard operating procedures for investigators
• Standard operating procedures for sponsors and CROs
• GCP — an indexed reference

Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels. Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was — for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators ensure that nothing important is overlooked. The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.

International standards ensure that organisations operate the right processes to support their objectives. International Standards for Design and Manufacturing is an accessible guide for manufacturing and production managers and students. It guides readers through the standards needed to build operating systems which are robust and integrated. International Standards for Design and Manufacturing is based on a collaboration between Swansea University, BSI and manufacturing and production practitioners from key companies who have supplied cases of using standards in practice, such as Bosch, BP, Tesco, M&S and Toyota. Each chapter includes an introduction to the standards being discussed, definitions, case studies of using the standards in practice, statistics, why these standards are important, conclusions, seminar topics and exam questions.

The Pharmaceutical Studies Reader is an engaging survey of the field that brings together provocative, multi-disciplinary scholarship examining the interplay of medical science, clinical practice, consumerism, and the healthcare marketplace. * Draws on anthropological, historical, and sociological approaches to explore the social life of pharmaceuticals with special emphasis on their production, circulation, and consumption * Covers topics such as the role of drugs in shaping taxonomies of disease, the evolution of prescribing habits, ethical dimensions of pharmaceuticals, clinical trials, and drug research and marketing in the age of globalization * Offers a compelling, contextually-rich treatment of the topic that exposes readers to a variety of approaches, ideas, and frameworks * Provides an accessible introduction for readers with no previous background in this area

The period from the late seventeenth to the early nineteenth century-the so-called long eighteenth century of English history-was a time of profound global change, marked by the expansion of intercontinental empires, long-distance trade, and human enslavement. It was also the moment when medicines, previously produced locally and in small batches, became global products. As greater numbers of British subjects struggled to survive overseas, more medicines than ever were manufactured and exported to help them. Most historical accounts, however, obscure the medicine trade's dependence on slave labor, plantation agriculture, and colonial warfare. In Merchants of Medicines, Zachary Dorner follows the earliest industrial pharmaceuticals from their manufacture in the United Kingdom, across trade routes, and to the edges of empire, telling a story of what medicines were, what they did, and what they meant. He brings to life business, medical, and government records to evoke a vibrant early modern world of London laboratories, Caribbean estates, South Asian factories, New England timber camps, and ships at sea. In these settings, medicines were produced, distributed, and consumed in new ways to help confront challenges of distance, labor, and authority in colonial territories. Merchants of Medicines offers a new history of economic and medical development across early America, Britain, and South Asia, revealing the unsettlingly close ties among medicine, finance, warfare, and slavery that changed people's expectations of their health and their bodies.

Give and Take looks at local drug manufacturing in Kenya, Tanzania, and Uganda, from the early 1980s to the present, to understand the impact of foreign aid on industrial development. While foreign aid has been attacked by critics as wasteful, counterproductive, or exploitative, Nitsan Chorev makes a clear case for the effectiveness of what she terms "developmental foreign aid." Against the backdrop of Africa's pursuit of economic self-sufficiency, the battle against AIDS and malaria, and bitter negotiations over affordable drugs, Chorev offers an important corrective to popular views on foreign aid and development. She shows that when foreign aid has provided markets, monitoring, and mentoring, it has supported the emergence and upgrading of local production. In instances where donors were willing to procure local drugs, they created new markets that gave local entrepreneurs an incentive to produce new types of drugs. In turn, when donors enforced exacting standards as a condition to access those markets, they gave these producers an incentive to improve quality standards. And where technical know-how was not readily available and donors provided mentoring, local producers received the guidance necessary for improving production processes. Without losing sight of domestic political-economic conditions, historical legacies, and foreign aid's own internal contradictions, Give and Take presents groundbreaking insights into the conditions under which foreign aid can be effective.

The pharmaceutical industry is broken. From the American hedge fund manager who hiked the price of an AIDS pill from $17.50 to $750 overnight to the children's cancer drugs left intentionally to expire in a Spanish warehouse, the signs of this dysfunction are all around. A system that was designed to drive innovation and patient care has been relentlessly distorted to drive up profits. Medicines have become nothing more than financial assets. The focus of drug research, how drugs are priced and who has access to them is now dictated by shareholder value, not the good of the public. Drug companies fixated on ever-higher profits are being fined for bribing doctors and striking secret price-gouging deals, while patients desperate for life-saving medicines are driven to the black market in search of drugs that national health services can't afford. Sick Money argues that the way medicines are developed and paid for is no longer working. Unless we take action we risk a dramatic decline in the pace of drug development and a future in which medicines are only available to the highest bidder. In this book investigative journalist Billy Kenber offers a diagnosis of an industry in crisis and a prescription for how we can fight back.

Millions of people in the third world die from diseases that are rare in the first world--diseases like malaria, tuberculosis, and schistosomiasis. AIDS, which is now usually treated in rich countries, still ravages the world's poor. Vaccines offer the best hope for controlling these diseases and could dramatically improve health in poor countries. But developers have little incentive to undertake the costly and risky research needed to develop vaccines. This is partly because the potential consumers are poor, but also because governments drive down prices. In Strong Medicine, Michael Kremer and Rachel Glennerster offer an innovative yet simple solution to this worldwide problem: "Pull" programs to stimulate research. Here's how such programs would work. Funding agencies would commit to purchase viable vaccines if and when they were developed. This would create the incentives for vaccine developers to produce usable products for these neglected diseases. Private firms, rather than funding agencies, would pick which research strategies to pursue. After purchasing the vaccine, funders could distribute it at little or no cost to the afflicted countries. Strong Medicine details just how these legally binding commitments would work. Ultimately, if no vaccines were developed, such a commitment would cost nothing. But if vaccines were developed, the program would save millions of lives and would be among the world's most cost-effective health interventions.

Gary Gereffi first explains how foreign corporations took over the flourishing Mexican steroid industry in the 1950s and 1960s and thwarted the country's later attempts to establish a more equitable distribution of industry benefits. In this valuable theoretical contribution Professor Gereffi uses the Mexican industry's plight as a crucial-case test for dependency theory Originally published in 1983. The Princeton Legacy Library uses the latest print-on-demand technology to again make available previously out-of-print books from the distinguished backlist of Princeton University Press. These editions preserve the original texts of these important books while presenting them in durable paperback and hardcover editions. The goal of the Princeton Legacy Library is to vastly increase access to the rich scholarly heritage found in the thousands of books published by Princeton University Press since its founding in 1905.

Despite the pharmaceutical industry's notable contributions to human progress, including the development of miracle drugs for treating cancer, AIDS, and heart disease, there is a growing tension between the industry and the public. Debates are raging over how the industry can and should be expected to act. In this volume leading figures in industry, government, NGOs, the medical community, and academia discuss and propose solutions to the ethical dilemmas of drug industry behavior. They examine such aspects as the role of intellectual property rights and patent protection, the moral and economic requisites of research and clinical trials, drug pricing, marketing and advertising. . Michael Santoro is Associate Professor with tenure in the Business Environment Department at Rutgers Business School, where he teaches courses on business ethics, public policy, labor and human rights, law, ethical issues in the pharmaceutical industry and China business strategy. As a Research Associate at Harvard Business School, he wrote or co-authored nearly thirty case studies and teaching notes on ethical and legal topics such as global protection of intellectual property, insider trading, the Federal Sentencing Guidelines and Fair Credit Reporting Act. Thomas Gorrie is Corporate Vice President, Government Affairs & Policy, at Johnson & Johnson, with responsiblity for all federal, state and international government affairs and policy. He completed post-doctoral studies at the Swiss Federal Institute of Technology in Zurich, following the receipt of his doctorate at Princeton University. Gorrie has over 30 years of worldwide health care experience and has worked with various Johnson & Johnson companies inresearch and development, marketing and sales, business development, strategic planning, general management, international, venture capital, and health policy.

Ernest Solvay, philanthropist and organizer of the world-famous Solvay conferences on physics, discovered a profitable way of making soda ash in 1861. Together with a handful of associates, he laid the foundations of the Solvay company, which successfully branched out to other chemicals, plastics, and pharmaceuticals. Since its emergence in 1863, Solvay has maintained world leadership in the production of soda ash. This is the first scholarly book on the history of the Solvay company, which was one of the earliest chemical multinationals and today is among the world's twenty largest chemical companies. It is also one of the largest companies in the field to preserve its family character. The authors analyze the company's 150-year history (1863 2013) from economic, political, and social perspectives, showing the enormous impact geopolitical events had on the company and the recent consequences of global competition."

The pharmaceutical industry worldwide is a rapidly burgeoning industry contributing to growth of gross domestic product and employment. Technological change in this field has been very rapid, with many new products being introduced. For this reason in part, health care budgets throughout the world have increased dramatically, eliciting growing pressures for cost containment. This book explores four important issues in pharmaceutical innovations: (1) the industry structure of pharmaceutical innovation; (2) incentives for correcting market failures in allocating resources for research and development; (3) competition and marketing; and (4) public evaluation of the benefits and costs of innovation. The lessons are applicable to countries all over the world, at all levels of economic development. By discussing existing evidence this book proposes incentive arrangements to accomplish social objectives.

Gary Gereffi first explains how foreign corporations took over the flourishing Mexican steroid industry in the 1950s and 1960s and thwarted the country's later attempts to establish a more equitable distribution of industry benefits. In this valuable theoretical contribution Professor Gereffi uses the Mexican industry's plight as a crucial-case test for dependency theory Originally published in 1983. The Princeton Legacy Library uses the latest print-on-demand technology to again make available previously out-of-print books from the distinguished backlist of Princeton University Press. These editions preserve the original texts of these important books while presenting them in durable paperback and hardcover editions. The goal of the Princeton Legacy Library is to vastly increase access to the rich scholarly heritage found in the thousands of books published by Princeton University Press since its founding in 1905.

Medicinal Chemistry of Anticancer Drugs, Third Edition provides an updated resource for students and researchers from the point-of-view of medicinal chemistry and drug design, focusing on the mechanism of action of antitumor drugs from the molecular level, and on the relationship between chemical structure and chemical and biochemical reactivity of antitumor agents. The new edition includes updated sections on the hot topic of cancer immunotherapy, cancer polypharmacology, multitargeted cancer therapy, medicinal chemistry of cancer diagnosis, theragnostic anticancer agents, and pre-mRNA processing in cancer. Although many books are available that deal with clinical aspects of cancer chemotherapy, this book provides a unique and valuable perspective from the point-of-view of medicinal chemistry and drug design. It will be useful to undergraduate and postgraduate students of medicinal chemistry, pharmacology, biological chemistry, pharmacy and other health sciences. Researchers and practitioners will find a comprehensive treatment of the topic and a large number of references, reviews and primary literature.

Situated at the crossroads between the history of colonialism, of modern Southeast Asia, and of medical pluralism, this history of medicine and health traces the life of pharmaceuticals in Vietnam under French rule. Laurence Monnais examines the globalization of the pharmaceutical industry, looking at both circulation and consumption, considering access to drugs and the existence of multiple therapeutic options in a colonial context. She argues that colonialism was crucial to the worldwide diffusion of modern medicines and speaks to contemporary concerns regarding over-reliance on pharmaceuticals, drug toxicity, self-medication, and the accessibility of effective medicines. Retracing the steps by which pharmaceuticals were produced and distributed, readers meet the many players in the process, from colonial doctors to private pharmacists, from consumers to various drug traders and healers. Yet this is not primarily a history of medicines as objects of colonial science, but rather a history of medicines as tools of social change.

The pharmaceutical industry is broken. From the American hedge fund manager who hiked the price of an AIDS pill from $17.50 to $750 overnight to the children's cancer drugs left intentionally to expire in a Spanish warehouse, the signs of this dysfunction are all around. A system that was designed to drive innovation and patient care has been relentlessly distorted to drive up profits. Medicines have become nothing more than financial assets. The focus of drug research, how drugs are priced and who has access to them is now dictated by shareholder value, not the good of the public. Drug companies fixated on ever-higher profits are being fined for bribing doctors and striking secret price-gouging deals, while patients desperate for life-saving medicines are driven to the black market in search of drugs that national health services can't afford. Sick Money argues that the way medicines are developed and paid for is no longer working. Unless we take action we risk a dramatic decline in the pace of drug development and a future in which medicines are only available to the highest bidder. In this book investigative journalist Billy Kenber offers a diagnosis of an industry in crisis and a prescription for how we can fight back.