Drug Regulation and Cost Recovery PDF Download

Author: G. Bruce Doern
Publisher: Canadian Centre for Management Development
ISBN: 9780662177364
Category : Drugs
Languages : en
Pages : 28

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Book Description

Author: Daniel Hoffman
Publisher: Routledge
ISBN: 1000166716
Category : Business & Economics
Languages : en
Pages : 95

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Book Description
The pharmaceutical industry, long thought of as a recession-proof investment, now faces a day of reckoning. The reasons for this impending downfall are not hard to discern. The prices the industry charges for its prescription drugs have escalated at four to five times the cost-of-living increases during the past two decades and have reached a point where 30% of Americans must choose between filling a prescription, paying for housing, and buying food. This has brought about public pressure on governments around the world to control drug prices, yet the world’s twenty largest pharma companies realized 80% of their growth as a result of exorbitant price hikes. Pharma currently enjoys its extraordinary profitability by exploiting the world’s most vulnerable populations. Yet even their ability to increase prices in the face of falling demand does not satisfy their profit demands. The breadth and depth of pharma’s marketing transgressions exceed those of any other industry and have now reached a point where authorities around the world have found it necessary to take legal action against its violations. Drastic change is needed if the pharmaceutical industry can equitably advance the health of the world’s population and regain public esteem. This book illustrates the range and extent of pharma’s violations and addresses the actions that should be implemented in order to make the drug industry a more constructive, less venal part of contemporary society. It will be of interest to researchers, academics, practitioners, and students with an interest in the pharmaceutical industry, healthcare management, regulation, and bioethics.

Author: Albert I. Wertheimer
Publisher: CRC Press
ISBN: 1000156842
Category : Medical
Languages : en
Pages : 390

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Book Description
Learn how international governments have committed themselves to improving access to quality health care! International Drug Regulatory Mechanisms explores the environment, organization, structure, functioning, and finance of health systems and pharmaceutical markets in 19 countries. Local experts describe each country’s experiences with and lessons learned from the regulation of pharmaceutical products. This book will help government officials, pharmacy educators, and pharmaceutical industry leaders from around the globe identify and develop successful methods for controlling pharmaceutical drug prices and utilization. In International Drug Regulatory Mechanisms, you will learn about the health care system of each country and each government’s measures to control drug costs. This text shows you what government interventions are feasible as well as effective, and the impact of these measures on consumers, government agencies, and the pharmaceutical companies and distributors. Drug policies, reimbursement concepts, and health insurance companies are all examined to give you a better working knowledge of the methodology and guidelines involving drug control in nations such as: Iceland Canada Israel Malaysia Argentina Taiwan Mexico Italy International Drug Regulatory Mechanisms is an extensive text that shows how pharmaceuticals are regulated throughout the world. This book examines how—despite similar goals—price controls, utilization controls, record keeping, and quality requirements differ greatly between countries. Using numerous graphs, tables, and figures, this one-of-a-kind resouce provides you with new insight into which strategies are superior and how to implement these strategies in your own country.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442

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Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Author: Peter Temin
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 296

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Book Description
A history of the federal regulation of the sale and use of medicinal drugs throughout the twentieth century examines the reasons for and impact of Federal Food and Drug Administration.

Author:
Publisher: DIANE Publishing
ISBN: 9780788104688
Category : Drugs
Languages : en
Pages : 380

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Book Description
Analyzes the costs, risks, and economic rewards of pharmaceutical R&D and the impact of public policy on both costs and returns. Examines the rapid increase in pharmaceutical R&D that began in the 1980s in the light of trends in science, technology, drug discovery, and health insurance coverage; Government regulation; product liability; market competition; Federal tax policy; and Federal support of prescription drug research. 12 appendices, including a glossary of terms.

Author: Guy Lewis Sides
Publisher:
ISBN:
Category : Drug traffic
Languages : en
Pages : 75

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Book Description

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309042860
Category : Medical
Languages : en
Pages : 241

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Book Description
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483

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Book Description
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Author: Brita A.K. Pekarsky
Publisher:
ISBN: 9783319089041
Category :
Languages : en
Pages :

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Book Description
This comprehensive text presents a rigorous framework from within which regulators can respond strategically to the claim by the pharmaceutical industry that lower drug prices today lead to a loss for the population's future health due to less innovation. It starts with a critical review of the empirical evidence of the return to consumers on their ongoing investment into high drug prices in order to increase future innovation. The implicit, critical and unrealistic assumption inherent in these studies is identified, namely that the health budget can be expanded to purchase drugs at higher prices without an opportunity cost, for example, the foregone benefits of alternative investments in health care infrastructure. Price effectiveness analysis (PEA), is introduced. PEA informs the question of how the innovative surplus from the new drug should be allocated between the manufacturer and the consumer so as to optimise society's welfare. The method allows the decisions by the regulator and the firm to be analysed jointly by specifying the firm's production and revenue functions in terms of the clinical innovation of a new drug; the incremental effect used in the summary metric of cost effectiveness analysis. An economic value of innovation that takes into account opportunity cost under conditions of economic efficiency in the health system is proposed: the health shadow price. The limitations of the non-strategic methods that currently inform the highly contested new drug subsidy game are presented and the relative strengths of PEA are demonstrated. Health technology assessment quantifies both the clinical innovation of a new drug and its financial impact on the health system. Cost effectiveness analysis tests the relationship between the incremental cost and incremental effect of a new drug for target patients, at a given price. PEA tests the relationship between the price of a new drug and the health of the whole population, now and into the future. It achieves this by taking into account current inefficiency in both resource allocation and the displacement process, and the relationship between price and future innovation.