Browsing by Author "Grabowski, HG"
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Item Open Access A Computer Simulation Model of Pharmaceutical Innovation(Pharmaceutical Economics: Papers Presented at the 6. Arne Ryde Symposium, Helsingborg, Sweden 1982, 1984) Grabowski, HG; Vernon, JohnItem Open Access A Computer Simulation Model of Pharmaceutical Innovation(Pharmaceutical Economics, 1984) Grabowski, HG; Vernon, JohnItem Open Access An Economic Analysis of Global Policy Proposals to Prohibit Compensation of Blood Plasma Donors(International Journal of the Economics of Business, 2016-05-03) Grabowski, HG; Manning, RL© 2016 International Journal of the Economics of Business.Human blood plasma and its derivative therapies have been used therapeutically for more than 50 years, after first being widely used to treat injuries during World War II. In certain countries, manufacturers of these therapies – known as plasma-derived medicinal products (PDMPs) – compensate plasma donors, raising healthcare and ethical concerns among some parties. In particular, the World Health Organization has taken a strong advocacy position that compensation for blood donations should be eliminated worldwide. This review evaluates the key economic factors underlying the supply and demand for PDMPs and the evidence pointing to the policy options that are most likely to maintain a reliable supply of life-sustaining therapies. It concludes that compensated plasma donation is important for maintaining adequate and consistent supplies of plasma and limits the risk of under-treatment for the foreseeable future.Item Open Access Competition between Generic and Branded Drugs(Pharmaceutical innovation: incentives, competition, and cost-benefit analysis in international perspective, 2007-04-30) Grabowski, HGThe pharmaceutical industry worldwide is a rapidly burgeoning industry contributing to growth of gross domestic product and employment. Technological change in this field has been very rapid, with many new products being introduced. For this reason in part, health care budgets throughout the world have increased dramatically, eliciting growing pressures for cost containment. This book explores four important issues in pharmaceutical innovations: (1) the industry structure of pharmaceutical innovation; (2) incentives for correcting market failures in allocating resources for research and development; (3) competition and marketing; and (4) public evaluation of the benefits and costs of innovation. The lessons are applicable to countries all over the world, at all levels of economic development. By discussing existing evidence this book proposes incentive arrangements to accomplish social objectives.Item Open Access Cost of innovation in the pharmaceutical industry.(J Health Econ, 1991-07) DiMasi, JA; Hansen, RW; Grabowski, HG; Lasagna, LThe research and development costs of 93 randomly selected new chemical entities (NCEs) were obtained from a survey of 12 U.S.-owned pharmaceutical firms. These data were used to estimate the pre-tax average cost of new drug development. The costs of abandoned NCEs were linked to the costs of NCEs that obtained marketing approval. For base case parameter values, the estimated out-of-pocket cost per approved NCE is $114 million (1987 dollars). Capitalizing out-of-pocket costs to the point of marketing approval at a 9% discount rate yielded an average cost estimate of $231 million (1987 dollars).Item Open Access Economic Evaluation of Drug Treatment for Psychiatric Disorders: The New Clinical Trial Protocol(Psychopharmacology: the Fourth Generation of Progress, 1995) Zarkin, Gary A.; Grabowski, HG; Mauskopf, Josephine; Bannerman, Heather A.; Weisler, Ricard H.Item Open Access Encouraging innovative treatment of neglected diseases through priority review vouchers(Prescribing Cultures and Pharmaceutical Policy in the Asia-Pacific, 2009-09-01) Grabowski, HG; Ridley, David B.; Moe, Jeffrey L.Item Open Access Entry and competition in generic biologics(Managerial and Decision Economics, 2007-06-01) Grabowski, HG; Ridley, DB; Schulman, KAPatents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologies can and should be treated like pharmaceuticals with regard to generics. In contrast with pharmaceuticals, which are manufactured through chemical synthesis, biologies are manufactured through fermentation, a process that is more variable and costly. Regulators might require extensive clinical testing of generic biologies to demonstrate equivalence to the branded product. The focus of the debate on generic biologies has been on legal and health concerns, but there are important economic implications. We combine a theoretical model of generic biologies with regression estimates from generic pharmaceuticals to estimate market entry and prices in the generic biologic market. We find that generic biologies will have high fixed costs from clinical testing and from manufacturing, so there will be less entry than would be expected for generic pharmaceuticals. With fewer generic competitors, generic biologies will be relatively close in price to branded biologies. Policy makers should be prudent in estimating financial benefits of generic biologies for consumers and payers. We also examine possible government strategies to promote generic competition. Copyright © 2007 John Wiley & Sons, Ltd.Item Open Access Estimating the Effects of Regulation on Innovation: An International Comparative Analysis of the Pharmaceutical Industry(1978) Grabowski, HG; Vernon, JM; Thomas, LGINNOVATION in the U.S. ethical drug industry in recent years has been characterized by a number of adverse developments. In particular, there has been a sharp decline in the rate of new product introductions and the incentive for engaging in research and development (R & D) activity has been negatively influenced by rapid increases in the costs and risks of developing new products. While there is little debate about the existence of these adverse trends, there is considerable controversy about the factors producing them. Briefly, we list below five hypotheses that have been discussed as explanations for the declining rate of innovation.`Item Open Access FDA in the Twenty-First Century(FDA Regulation Of Biosimilars, 2015) Grabowski, HGItem Open Access Generic competition and market exclusivity periods in pharmaceuticals(Managerial and Decision Economics, 2007-06-01) Grabowski, HG; Kyle, MIn this paper we examine generic competition and market exclusivity periods for pharmaceuticals experiencing their initial generic entry between 1995 and 2005. We find that generic competition has increased over several dimensions. First, an increasing number of drugs are subject to generic entry, including drugs with relatively modest annual average sales. Second, drugs with larger sales attract more generic entrants and have shorter market exclusivity periods than smaller selling drugs. Third, blockbuster drugs with annual sales in excess of $1 billion have experienced significant decreases in their market exclusivity periods in recent years. We also find that Hatch-Waxman Act patent challenges have negatively affected market exclusivity periods over the 1995 to 2005 period. Copyright © 2007 John Wiley & Sons, Ltd.Item Open Access Graph-Oriented Model for Research Management(Research program effectiveness. Proceedings of the conference sponsored by the Office of Naval Research, Washington, D.C., July 27-29, 1965. Edited by M. C. Yovits [and others], etc, 1966) Grabowski, HGItem Open Access Impact of Public Policy on Drug Innovation and Pricing(Impact of Public Policy on Drug Innovation and Pricing, 1976) Grabowski, HG; Vernon, John; Thomas, Lacy GlennItem Open Access Increasing R&D incentives for neglected diseases: Lessons from the Orphan Drug Act(International Public Goods And Transfer Of Technology Under A Globalized Intellectual Property Regime, 2005) Grabowski, HGDistinguished economists, political scientists, and legal experts discuss the implications of the increasingly globalized protection of intellectual property rights for the ability of countries to provide their citizens with such important public goods as basic research, education, public health, and environmental protection. Such items increasingly depend on the exercise of private rights over technical inputs and information goods, which could usher in a brave new world of accelerating technological innovation. However, higher and more harmonized levels of international intellectual property rights could also throw up high roadblocks in the path of follow-on innovation, competition and the attainment of social objectives. It is at best unclear who represents the public interest in negotiating forums dominated by powerful knowledge cartels. This is the first book to assess the public processes and inputs that an emerging transnational system of innovation will need to promote technical progress, economic growth and welfare for all participants.Item Open Access Increasing R&D Incentives for Neglected Diseases: Lessons from the Orphan Drug Act(International Public Goods And Transfer Of Technology Under A Globalized Intellectual Property Regime, 2005) Grabowski, HGItem Open Access Innovation and International Competitiveness in Pharmaceuticals(Evolving Technology and Market Structure: Studies in Schumpeterian Economics, 1990) Grabowski, HGItem Open Access Mergers and Alliances in Pharmaceutical: Effects on Innovation and R&D Productivity(The Economics of Corporate Governance and Mergers, 2008-01-01) Grabowski, HG; Kyle, MargaretThis book provides an insightful view of major issues in the economics of corporate governance (CG) and mergers. It presents a systematic update on the developments in the two fields during the last decade, as well as highlighting the neglected topics in CG research, such as the role of boards, CG and public interest and the relation of CG to mergers. Two important conclusions can be drawn from this book: the first is that corporate governance systems that better align shareholders and managers interests lead to better corporate performance; second, there is an important relationship between CG structures and the quality of firm decision-making, one of the most important being the decision to merge or take over another firm. Focusing on some of the often-neglected aspects of corporate governance such as non-profit organizations and public interest, as well as mergers and acquisitions from a CG perspective, this book will be a valuable resource for both academics and postgraduate students of finance, business and economics.Item Open Access Mergers, Acquisitions, and Alliances(The Oxford Handbook of the Economics of the Biopharmaceutical Industry, 2012-09-18) Grabowski, HG© 2012 by Oxford University Press. All rights reserved.This article considers the determinants and effects of M&As in the pharmaceutical industry, with a particular focus on innovation and R&D productivity. As is the case in other industries, mergers in the pharmaceutical field are driven by a variety of company motives and conditions. These include defensive responses to industry shocks as well as more proactive rationales, such as economies of scale and scope, access to new technologies, and expansion to new markets. It is important to take account of firms' characteristics and motivations in evaluating merger performance, rather than using a broad aggregate brushstroke. Research to date on pharmaceuticals suggests considerable variation in both motivation and outcomes. From an antitrust policy standpoint, the larger horizontal mergers in pharmaceuticals have run into few challenges from regulatory authorities in the United States and the European Union, given the option to spin off competing therapeutic products to other drug firms.Item Open Access Pharmaceuticals and Health Care CostsGrabowski, HGItem Open Access Pressures from the Demand Side: Changing Market Dynamics and Industrial Structure(Consolidation and Competition in the Pharmaceutical Industry, 2001) Grabowski, HG; Vernon, John