Download or read book Pharmaceutical R D written by and published by DIANE Publishing. This book was released on 1993 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmaceutical R D costs risks and rewards written by and published by DIANE Publishing. This book was released on 1993 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical R and D written by Office of Technology Assessment and published by . This book was released on 2005 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical costs are among the fastest growing components of health care costs today. Although increases in the inflation-adjusted prices of ethical drugs and perceived high prices of new drugs have been a concern of congressional committees for over 30 years, the growing Federal role in paying for prescription drugs has increased the concern over the appropriateness of prices relative to the costs of bringing new drugs to market. Specific policies of U.S. and other governments can alter the delicate balance between costs and returns to pharmaceutical R&D, with ramifications for the future health of Americans, for health care costs, and for the future of the U.S. pharmaceutical industry. OTA's report focuses mainly on the economic side of the R&D process. Pharmaceutical R&D is an investment, and the principal characteristic of an investment is that money is spent today in the hopes of generating even more money in the future. Pharmaceutical R&D is a risky investment; therefore, high financial returns are necessary to induce companies to invest in researching new chemical entities. Changes in Federal policy that affect the cost, uncertainty and returns of pharmaceutical R&D may have dramatic effects on the investment patterns of the industry. Given this sensitivity to policy changes, careful consideration of the effects on R&D is needed. The specific request for this study came from the House Committee on Energy and Commerce and its Subcommittee on Health and the Environment. The Senate Committee on the Judiciary's Subcommittee on Antitrust, Monopolies, and Business Rights endorsed the study. OTA was assisted in this study by an advisory panel of business, consumer, and academicleaders chaired by Frederick M. Scherer, Ph.D., Professor of Economics, John E Kennedy School of Government at Harvard University. OTA gratefully acknowledges the contribution of each of these individuals. As with all OTA reports, the final responsibility for the content of the assessment rests with OTA.
Download or read book Pharmaceutical R D written by Office of Technology Assessment (Washington, DC). and published by . This book was released on 1993 with total page 41 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical R D written by and published by U.S. Government Printing Office. This book was released on 1993 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research and development expenditures -- The costs of pharmaceuticul r & d -- Returns on pharmaceutical r & d -- Trends in science, technology and drug discovery -- Government regulation and pharmaceutical r & d -- Product liability and the pharmaceutical industry -- Federal tax policy and drug research and development -- Federal support for pharmaceutical research and development -- Trends in payment for prescription drugs.
Download or read book A Critical Appraisal of OTA s Pharmaceutical R D Costs Risks and Rewards written by Jerome E. Hass and published by . This book was released on 1994 with total page 19 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical R D Costs Risks and Rewards written by United States. Congress. Office of Technology Assessment. Subcommittee on Health and the Environment and published by . This book was released on 1993 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Research and Development in the Pharmaceutical Industry A CBO Study written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...
Download or read book Benefit Risk Assessment in Pharmaceutical Research and Development written by Andreas Sashegyi and published by CRC Press. This book was released on 2013-11-27 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations relevant to benefit-risk assessment across the pharmaceutical R&D spectrum, from early clinical development to late-stage development to regulatory review to post-launch assessment. The book first presents interpretations of benefit and risk in the context of a molecule moving from preclinical evaluation into its early testing in humans. It next considers benefit and risk characterization and assessment during a molecule’s journey from its clinical evaluation in humans through its submission to regulators for marketing approval. Throughout these sections, the book offers insight into the role of benefit-risk assessment in heightening understanding among key stakeholders by shaping questions and guiding discussions among scientists, physicians, developers, and regulatory agencies. The book also focuses on a molecule’s entry into the marketplace as a drug available for consumption by people. It explores the role of benefit-risk assessment as the relevance of carefully collected clinical efficacy and safety metrics fades in the wake of real-world use and evidence of effectiveness and safety. Bringing together the expertise of 15 contributors from academia and the industry, this book offers an easy-to-read guide to the various facets of benefit-risk assessment in the major stages of pharmaceutical R&D. Suitable for those in both technical and managerial roles, it enables readers to communicate more effectively across their development chain as well as rationally and thoughtfully embed benefit-risk assessment into their R&D processes.
Download or read book Pharmaceutical R D and the Evolving Market for Prescription Drugs written by David Austen and published by DIANE Publishing. This book was released on 2010-11 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt: Investment in R&D over the past several decades has produced many valuable new drug therapies that have made it possible to treat major illnesses that were not treated previously. Spending on prescription drugs became the fastest-growing category of total spending on health care in the U.S. Between 1994 and 2004, real spending on prescription drugs rose at an average annual rate of 11%, compared with 3% for hospital care and 4% for physicians¿ services. More recently, however, that growth has slowed. This report describes the current state of investment in drug R&D and the factors that influence it. It also examines how various policy options to control the growth in health care costs or to expand insur. coverage could affect R&D spending. Illus.
Download or read book Understanding the Benefits and Risks of Pharmaceuticals written by Institute of Medicine and published by National Academies Press. This book was released on 2007-09-14 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt: All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them. To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.
Download or read book Powerful Medicines written by Jerry Avorn, M.D. and published by Vintage. This book was released on 2008-12-10 with total page 476 pages. Available in PDF, EPUB and Kindle. Book excerpt: If you believe that the latest blockbuster medication is worth a premium price over your generic brand, or that doctors have access to all the information they need about a drug’s safety and effectiveness each time they write a prescription, Dr. Jerry Avorn has some sobering news. Drawing on more than twenty-five years of patient care, teaching, and research at Harvard Medical School, he shares his firsthand experience of the wide gap in our knowledge of the effectiveness of one medication as compared to another. In Powerful Medicines, he reminds us that every pill we take represents a delicate compromise between the promise of healing, the risk of side effects, and an increasingly daunting price. The stakes on each front grow higher every year as new drugs with impressive power, worrisome side effects, and troubling costs are introduced. This is a comprehensive behind-the-scenes look at issues that affect everyone: our shortage of data comparing the worth of similar drugs for the same condition; alarming lapses in the detection of lethal side effects; the underuse of life-saving medications; lavish marketing campaigns that influence what doctors prescribe; and the resulting upward spiral of costs that places vital drugs beyond the reach of many Americans. In this engagingly written book, Dr. Avorn asks questions that will interest every consumer: How can a product judged safe by the Food and Drug Administration turn out to have unexpectedly lethal side effects? Why has the nation’s drug bill been growing at nearly 20 percent per year? How can physicians and patients pick the best medication in its class? How do doctors actually make their prescribing decisions, and why do those decisions sometimes go wrong? Why do so many Americans suffer preventable illnesses and deaths that proper drug use could have averted? How can the nation gain control over its escalating drug budget without resorting to rationing or draconian governmental controls? Using clinical case histories taken from his own work as a practitioner, researcher, and advocate, Dr. Avorn demonstrates the impressive power of the well-conceived prescription as well as the debacles that can result when medications are misused. He describes an innovative program that employs the pharmaceutical industry’s own marketing techniques to reduce use of some of the most overprescribed and overpriced products. Powerful Medicines offers timely and practical advice on how the nation can improve its drug-approval process, and how patients can work with doctors to make sure their prescriptions are safe, effective, and as affordable as possible. This is a passionate and provocative call for action as well as a compelling work of clear-headed science.
Download or read book Risks and Rewards of Pharmaceutical Research written by John Weilburg and published by . This book was released on 1958* with total page 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 Drug Benefits and Risks written by Chris J. van Boxtel and published by John Wiley & Sons. This book was released on 2001-11-28 with total page 738 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is an inclusive reference exploring the scientific basis and practice of drug therapy. The key concept is to look at the balance between the benefits and risks of drugs but in this context also the social impact which drugs have in modern societies is highlighted. Taking an evidence-based approach to the problem, the practice of clinical pharmacology and pharmacotherapy in the developing as well as the developed world is examined. For this purpose the book * Covers general clinical pharmacology, pharmacology of various drug groups and the treatments specific to various diseases * Gives guidance on how doctors should act so that drugs can be used effectively and safely * Encourages the rational use of drugs in society This book brings together a large amount of excellent content that will be invaluable for anyone working within, or associated with, the field of clinical pharmacology and pharmacotherapy - undergraduates, postgraduates, regulatory authorities and the pharmaceutical industry.
Download or read book Competitive Strategies in the Pharmaceutical Industry written by Robert B. Helms and published by A E I Press. This book was released on 1996 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: The growth of government programs and managed care has altered how pharmaceuticals are marketed and sold in the United States. Such change has shortened the expected revenue stream from most products - even though new technologies have increased both the cost and the medical attractiveness of those products. Managers of government and private health care programs are looking for new ways to reduce the cost of drug benefits, while company R&D managers are seeking ways to speed the regulatory process and develop new markets to cover the increasing cost of research. This volume examines various aspects of the continuing policy dispute and offers several views on the future of the pharmaceutical industry.
Download or read book Pharmaceutical Price Regulation written by Patricia Munch Danzon and published by A E I Press. This book was released on 1997 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: The high cost of R&D makes pharmaceuticals vulnerable to aggressive price regulation. Yet even stringent price regulatory systems have failed to control total drug expenditures. The challenge for public policy, the author states, is securing a balance between controlling health care spending today and preserving incentives for innovative R&D for health and the quality of life tomorrow.
