Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry to account through greater transparency.

There is plenty of controversy surrounding pharmaceuticals, but it cannot be denied that the pharmaceutical industry is both socially beneficial and profitable. Regulators are expected to ensure that the economic success of the industry does not come at the expense of public safety, yet they have also assumed a cooperative role by providing advice on regulation and by targeting unmet medical needs. Concerns over regulatory standards, conflicts of interest, and the manipulation of information on drug safety and effectiveness have led to public mistrust and a greater need for transparency between the pharmaceutical industry and government regulators. Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry responsible for creating transparency in the industry, from development to market. The contributors to this volume examine the various mechanisms introduced to make the regulatory process more informative and situate these efforts within the larger project of enhancing the safety of drugs, vaccines, and other products.

Incorporating HC 1030-i to iii.

One way this relationship is manifested is the But the state does not possess the wherewithal to agreement between the industry and the TPD that undertake the elaborate clinical and pre-clinical all of the information that companies submit as trials required to meet the objective of providing part of the regulatory approval process is deemed safe and effective medications. [...] Accordingly, in November 1996 I made a "loaned" to the government for purposes of review request through the Access to Information Act for but the companies do so with the expectation that "all studies that the Health Protection Branch has the review will produce material gains through that deal with the question of the efficacy of: marketing of their products. [...] Personal data or usefulness of the data submitted; the scientific that enters the files of regulatory agencies like the atmosphere in the agency may be stifled and the TPD can include the identity of individual patients professional growth of its staff severely inhibited. [...] This part of the Out of the three proposals that have been put protocol was not followed and the authors made forward, the use of SBDs is the most advanced conclusions about subgroups despite the lack of and therefore merits a detailed analysis. [...] Canadian Centre for Policy Alternatives VII: Is the Summary Basis of Decision Adequate IN EACH OF THE FOUR EXAMPLES the Once a drug has been approved in the United problems would not have been discovered using States the FDA posts on its web site a detailed sum- Health Canada's SBDs due to the lack of detailed mary of the information that the company has sub- information of various types in these.

How the FDA became the world's most powerful regulatory agency 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. Some images inside the book are unavailable due to digital copyright restrictions.

Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

This report presents the findings of the first phase of the national Good Governance for Medicines programme in Jordan. In recent years, countries of the WHO Eastern Mediterranean Region have made significant achievements in the provision of health services. In the pharmaceutical field, countries have been striving to improve the structures and regulations pertaining to medicines and have progressed in many ways. However, there are still important challenges. The goal of the WHO Good Governance for Medicines programme is to improve the situation of medicines regulation and supply. National transparency assessment is the beginning of a process aimed at bringing about desirable and sustainable changes in the governance of the pharmaceutical sector.

The main strength of this book is that it examines the challenges facing the field of Bioethics today from medical, ethical and legal perspectives. A critical exchange of ideas from professionals in interdisciplinary fields allows everyone to learn and benefit from the insights gained through others' experiences. Examining, analyzing and understanding these complex medical-ethical-legal issues and cases and how they are resolved will serve as a paradigm for all professionals who will be confronted with these complex bioethical issues now and in the future. The more we face these challenges directly, examine them critically and debate them enthusiastically the more knowledge will be gained and hopefully, we will gain more practical wisdom.

​This book discusses the influence of the pharmaceutical industry on the practice of medicine, and the observed and potential pitfalls of such partnerships. It argues that the pharmaceutical industry has become indispensable to many of the activities of the medical profession across the pharmaceutical product lifecycle, and examines the regulatory, ethical, professional and institutional difficulties that arise from these interactions. With data drawn from over 80 qualitative accounts from medical, pharmaceutical, regulatory and healthcare professionals, this book uses both Hungary and the Netherlands as case studies to demonstrate the potential problem of undue pharmaceutical industry influence within the relationships fostered with the profession of medicine. Chapters systematically describe the lifecycle of a pharmaceutical product from research to distribution, demonstrating the interdependency of industry and medicine. Arguing that the medical profession should be a buffer between the pharmaceutical industry interests and patient interests, the book explores how undue industry influence weakens the ability of the medical profession to do so. Using the theory of institutional corruption, the book aims to analyze how conflict of interest and the weakening of institutional imperatives is a result of institutional interactions rather than individual actions. Appropriate for students and researchers of the pharmaceutical industry, corporate corruption, and those working in NGOs and policy making, this unique volume is an comprehensive look at the complex relationship between medicine and pharmacy.

Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.