Public Policy and Innovation in the U.S. Pharmaceutical Industry PDF Download

Author: Frank R. Lichtenberg
Publisher:
ISBN:
Category :
Languages : en
Pages : 0

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Book Description
Public policy can impact innovation, eitherencouraging or inhibiting the creation of innovative technologies.Howfive public policies have impacted continued innovation within the U.S.pharmaceutical industry is examined.At issue are the 1962 Kefauver-HarrisAmendment; the 1992 Prescription Drug User Fee Act; Medicare; Medicaid; and the1984 Hatch-Waxman Act. The policies set forth in each act are described, as are their effects oninnovation in the industry.Using a theoretical approach, the impactthat the speed and the ease of pharmaceutical imitation has upon pharmaceuticalinnovation is analyzed, with the belief that it impedes the rapidity ofinnovation within the industry.This theory is assessed, noting that theresearch on the impact of rapid imitation is mixed. The predicted impact of President Clinton's proposed 1993 health care reformpolicies is evaluated by studying the impact of the policies upon the marketvalue of pharmaceutical corporations and upon R&D investment. The findingsindicate that the proposed health care reform policies of the ClintonAdministration threatened the pharmaceutical industry, resulting in a reductionin the growth rate of R&D expenditure. (AKP).

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225

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Book Description
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.

Author: Alfonso Gambardella
Publisher: Cambridge University Press
ISBN: 0521451183
Category : Business & Economics
Languages : en
Pages : 236

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Book Description
This book examines an increasingly important phenomenon for competitiveness and innovation in industry: namely, the growing use of scientific principles in industrial research. Industrial innovation still arises from systematic trial-and-error experiments with many designs and objects, but these experiments are now being guided by a more rational understanding of phenomena. This has important implications for market structure, firm strategies, and competition. Science and innovation focuses on the pharmaceutical industry. It discusses the changes that the notable advances in the life sciences in the 1980s have brought to the strategies of drug companies, the organization of their internal research, their relationships with scientific institutions, the division of labor between large pharmaceutical firms and small research-intensive suppliers, the productivity of drug discovery, and the productivity of R&D.

Author: David H. Austin
Publisher:
ISBN:
Category : Drug development
Languages : en
Pages : 68

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Book Description

Author: Committee on Science, Engineering, and Public Policy
Publisher: National Academies Press
ISBN: 9780309293044
Category : Technology & Engineering
Languages : en
Pages : 0

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Book Description
Innovation has been a major engine of American economic and societal progress. It has increased per capita income more than sevenfold since the 19th century, has added three decades to the average lifespan, has revolutionized the way we communicate and share information, and has made the United States the strongest military power in the world. Without its historical leadership in innovation, the United States would be a very different country than it is today. Trends in the Innovation Ecosystem is the summary of two workshops hosted by the Committee on Science, Engineering, and Public Policy (COSEPUP) of the National Academy of Sciences, National Academy of Engineering, and Institute of Medicine in February and May, 2013. Experts from industry, academia, and finance met to discuss the challenges involved in innovation pathways. Both workshops focused on the interactions between research universities and industry and the concept of innovation as a "culture" as opposed to an operational method. The goal was to gain a better understanding of what key factors contributed to successful innovations in the past, how today's environment might necessitate changes in strategy, and what changes are likely to occur in the future in the context of a global innovation ecosystem. This report discusses the state of innovation in America, obstacles to both innovation and to reaping the benefits of innovation, and ways of overcoming those obstacles.

Author: Stuart O. Schweitzer
Publisher: Oxford University Press
ISBN: 0190293799
Category : Medical
Languages : en
Pages : 352

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Book Description
The pharmaceutical industry is praised as a world leader in high technology innovation and the creator of products that increase both longevity and quality of life for people throughout the world. At the same time, the industry is also criticized for its marketing and pricing practices and for its apparent anticompetitive responses to generic competition. Even its research and development priorities are criticized as being too closely driven by the goal of maximizing shareholder value, rather than the health of the public. Unfortunately, many of the critics of the industry fail to understand the complexities of the industry and its role in the nations healthcare system. This book uses the tools of economic analysis to explore the conflicting priorities and aims of the pharmaceutical industry, from both an American and worldwide perspective. This is the second edition of a uniquely comprehensive and balanced discussion of pharmaceutical policy issues. All the chapters of the former edition have been fully re-written and extensively updated. In addition, the book includes six new chapters on emerging topics such as the broadened role of FDA regulations and the increasing diversity of the industry. An entire chapter is devoted to the biotechnology industry and one to alternative medicines, often called "nutraceuticals." Another new chapter discusses segments of the industry that specialize in particular activities including generic drugs and drug delivery systems. The recent controversial expansion of Medicare to cover outpatient drugs is discussed in depth. The introduction is also updated to address the volatile pace of pharmaceutical innovation and how the pharmaceutical industry has responded to the emergence of managed care.

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498511
Category : Medical
Languages : en
Pages : 103

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Book Description
To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Author: Thomas R. Fulda
Publisher: CRC Press
ISBN: 1498748511
Category : Business & Economics
Languages : en
Pages : 504

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Book Description
As the most common health-care intervention, prescription drug use shares the most important characteristics of the health-care system in the United States. When everything works well, it makes possible breathtakingly successful applications of science to the prevention and cure of human suffering. But everything doesn‘t always work well. Pharmaceu

Author: Thomas Fulda
Publisher: CRC Press
ISBN: 9781439804261
Category : Medical
Languages : en
Pages : 714

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Book Description
Get an invaluable view of the impact of economics and politics on pharmaceuticals in the United States Pharmacy and pharmaceutical drug use are highly regulated and the various regulatory forces interact with diverse goals. Pharmaceutical Public Policy is a comprehensive review of the legislation, trends, business developments, and policy interpretations that have shaped drug use during the last 50 years. This unique single source explains drug regulatory activity, the major insurance and payment systems, and the impact of economics and politics on drug use in the United States. Leading experts provide a thorough and objective look at public policy issues, making this text perfect for upper level undergraduate and graduate level pharmacy, medical, and public health educators and students. Pharmacists and pharmacy students must learn more than just the physical sciences and clinical aspects of the pharmaceutical industry. The rationale for policies, rules, and regulations is integral to understanding how to best serve patients and make the entire pharmaceutical sector more equitable and cost-effective. Pharmaceutical Public Policy examines the most pressing issues facing the industry, including control of the rising costs for drugs and ensuring correct drug usage by patients. This insightful text offers an in depth perspective of the policies and the debates that surround them. Chapters are well-referenced and many include helpful figures and tables to illustrate facts and ideas. Topics in Pharmaceutical Public Policy include: pharmacy law and regulation Medicare and prescription drug coverage FDA drug approval process Medicaid and prescription drugs public health pharmacy Department of Veterans Affairs pharmacy programs Department of Defense pharmacy programs innovative state drug program practices state and federal regulation of pharmacy the future of the pharmaceutical industry managed care pharmacy PBM’s (pharmacy benefit managers) risk minimization importation and reimportation biotechnology and pharmacogenetics policy and issues product promotion competition between drugs drug insurance design patient compliance abuse of prescription drugs health care systems and insurance in Europe much more Pharmaceutical Public Policy is a one-of-a-kind resource that explains just who the players are and the complexity of the issues that are examined in most pharmaceutical policy debates, and is perfect for pharmacy students, educators, other health professionals, trade association leaders, and policymakers.

Author: Richard Allen Epstein
Publisher: Yale University Press
ISBN: 0300116640
Category : Law
Languages : en
Pages : 295

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Book Description
This book is the first to offer a comprehensive examination of the pharmaceutical industry by following the tortuous course of a new drug as it progresses from early development to final delivery. Richard A. Epstein looks closely at the regulatory framework that surrounds all aspects of making pharmaceutical products today, and he assesses which current legal and regulatory practices make sense and which have gone awry. While critics of pharmaceutical companies call for ever more stringent controls on virtually every aspect of drug development and approval, Epstein cautions that the effect of such an approach will be to stifle pharmaceutical innovation and slow the delivery of beneficial treatments to the patients who need them. The author considers an array of challenges that confront the industry--conflicts of interest among government, academe, and the drug companies; intellectual property rights that govern patents; FDA regulation; pricing disputes; marketing practices; and liability issues, including those brought to light in the recent VIOXX case. Epstein argues that to ensure the continuing creativity, efficiency, and success of the pharmaceutical industry, the best system will feature strong property rights and clearly enforceable contracts, with minimal regulatory and judicial interference.