Download or read book Policy Implications of Pharmaceutical Importation for U S Consumers written by United States. Congress. Senate. Committee on Commerce, Science, and Transportation. Subcommittee on Interstate Commerce, Trade, and Tourism and published by . This book was released on 2013 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Importing Into the United States written by U. S. Customs and Border Protection and published by . This book was released on 2015-10-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.
Download or read book Marking of Country of Origin on U S Imports written by and published by . This book was released on 1988 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Download or read book Intellectual Property Rights and International Trade written by Shayerah Ilias and published by Nova Publishers. This book was released on 2008 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction -- Intellectual property rights basics -- Global intellectual property holdings -- Contribution of intellectual property to U.S. economy -- The organized structure of IPR protection -- U.S. trade law -- Issues for Congress.
Download or read book WHO Guideline on Country Pharmaceutical Pricing Policies written by world health organization and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 or read book OECD Health Policy Studies Pharmaceutical Pricing Policies in a Global Market written by OECD and published by OECD Publishing. This book was released on 2008-09-24 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report assesses how pharmaceutical pricing and reimbursement policies have contributed to the achievement of certain health policy objectives, and it examines the national and transnational effects of these policies.
Download or read book Complying with the Made in USA Standard written by United States. Federal Trade Commission and published by . This book was released on 1998 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book MDS 3 written by Martha A. Embrey and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Managing Drug Supply (MDS) is the leading reference on how to manage essential medicines in developing countries. MDS was originally published in 1982; it was revised in 1997 with over 10,000 copies distributed in over 60 countries worldwide. The third edition, MDS-3: Managing Access to Medicines and Health Technologies reflects the dramatic changes in politics and public health priorities, advances in science and medicine, greater focus on health care systems, increased donor funding, and the advent of information technology that have profoundly affected access to essential medicines over the past 14 years. Nearly 100 experts from a wide range of disciplines and virtually every corner of the world have contributed to this third edition. In addition to many new country studies, references, and extensive revisions, MDS-3 offers new chapters on areas such as pharmaceutical benefits in insurance programs, pricing, intellectual property, drug seller initiatives, and traditional and complementary medicine. The revisions and new chapters echo the wide variety of issues that are important to health practitioners and policy makers today. MDS-3 will be a valuable tool in the effort to ensure universal access to quality medicines and health technologies and their appropriate use.
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Download or read book Pharmaceutical Price Regulation written by John A. Vernon and published by A E I Press. This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This monograph demonstrates empirically how the free-market system of drug pricing is vital to the development of new breakthrough drugs.
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Download or read book Corporate Crime in the Pharmaceutical Industry Routledge Revivals written by John Braithwaite and published by Routledge. This book was released on 2013-10-08 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 1984, this book examines corporate crime in the pharmaceutical industry. Based on extensive research, including interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala, the book is a major study of white-collar crime. Written in the 1980s, it covers topics such as international bribery and corruption, fraud in the testing of drugs and criminal negligence in the unsafe manufacturing of drugs. The author considers the implications of his findings for a range of strategies to control corporate crime, nationally and internationally.
Download or read book World Drug Report 2019 written by United Nations Office on Drugs and Crime and published by . This book was released on 1901 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2019 World Drug Report will include an updated overview of recent trends on production, trafficking and consumption of key illicit drugs. The Report contains a global overview of the baseline data and estimates on drug demand and supply and provides the reference point for information on the drug situation worldwide.
Download or read book Parallel Imports of Pharmaceuticals written by Cédric Julien Poget and published by Springer Science & Business Media. This book was released on 2007-12-20 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: Parallel trade occurs if international price differences for identical products are high and a policy of regional or international exhaustion of the respective property right has been implemented in the high price country. The work by C. Poget analyses how parallel imports of pharmaceuticals are affecting end consumer prices and drug expenditures in three Scandinavian countries, Sweden, Denmark and Norway. Based on his observations he derives proposals for policy reforms in EU member countries and Switzerland.
