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Henry G. Grabowski

Professor Emeritus of Economics
Economics
Box 90097, Durham, NC 27708-0097
314 Social Sciences, Durham, NC 27708

Selected Publications


Pharmaceutical Patent Challenges: Company Strategies and Litigation Outcomes

Journal Article American Journal of Health Economics · February 2017 Full text Cite

Updated trends in US brand-name and generic drug competition

Journal Article Journal of Medical Economics · September 1, 2016 Full text Open Access Cite

An Economic Analysis of Global Policy Proposals to Prohibit Compensation of Blood Plasma Donors

Journal Article International Journal of the Economics of Business · May 3, 2016 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 med ... Full text Open Access Cite

Innovation in the pharmaceutical industry: New estimates of R&D costs.

Journal Article Journal of health economics · May 2016 The research and development costs of 106 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug and biologics development. The costs of compounds abandoned ... Full text Open Access Cite

FDA Regulation of Biosimilars

Journal Article · September 16, 2015 Cite

The cost of drug development.

Journal Article The New England journal of medicine · May 2015 Full text Open Access Cite

The roles of patents and research and development incentives in biopharmaceutical innovation.

Journal Article Health affairs (Project Hope) · February 2015 Patents and other forms of intellectual property protection play essential roles in encouraging innovation in biopharmaceuticals. As part of the "21st Century Cures" initiative, Congress is reviewing the policy mechanisms designed to accelerate the discove ... Full text Open Access Cite

Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.

Journal Article Health affairs (Project Hope) · June 2014 In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing biosimilars to the market curren ... Full text Open Access Cite

Biosimilar competition: lessons from Europe

Journal Article Nature Reviews Drug Discovery · February 2014 Full text Open Access Cite

Biosimilars

Chapter · 2014 Cite

Recent Trends in Brand-Name and Generic Drug Competition

Journal Article Journal of Medical Economics · 2013 Open Access Cite

Does generic entry always increase consumer welfare?

Journal Article Food and drug law journal · January 2012 This article examines how the nature of competition between brands in a therapeutic category changes after generic entry and provide a framework for analyzing the effect of generic entry on consumer welfare that takes into account the generic free riding p ... Open Access Cite

Evolving brand-name and generic drug competition may warrant a revision of the Hatch-Waxman Act.

Journal Article Health affairs (Project Hope) · November 2011 The evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act's intended balance of incentives for cost savings and continued innovation has been achieved. Generic drug usage and chall ... Full text Open Access Cite

The Evolution of the Pharmaceutical Industry Over the Past 50 Years: A Personal Reflection

Journal Article International Journal of the Economics of Business · July 2011 Open Access Cite

Pharmaceutical Patent Challenges: Company Strategies and Litigation Outcomes

Journal Article American Journal of Health Economics · February 2017 Full text Cite

Updated trends in US brand-name and generic drug competition

Journal Article Journal of Medical Economics · September 1, 2016 Full text Open Access Cite

An Economic Analysis of Global Policy Proposals to Prohibit Compensation of Blood Plasma Donors

Journal Article International Journal of the Economics of Business · May 3, 2016 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 med ... Full text Open Access Cite

Innovation in the pharmaceutical industry: New estimates of R&D costs.

Journal Article Journal of health economics · May 2016 The research and development costs of 106 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug and biologics development. The costs of compounds abandoned ... Full text Open Access Cite

FDA Regulation of Biosimilars

Journal Article · September 16, 2015 Cite

The cost of drug development.

Journal Article The New England journal of medicine · May 2015 Full text Open Access Cite

The roles of patents and research and development incentives in biopharmaceutical innovation.

Journal Article Health affairs (Project Hope) · February 2015 Patents and other forms of intellectual property protection play essential roles in encouraging innovation in biopharmaceuticals. As part of the "21st Century Cures" initiative, Congress is reviewing the policy mechanisms designed to accelerate the discove ... Full text Open Access Cite

Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.

Journal Article Health affairs (Project Hope) · June 2014 In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing biosimilars to the market curren ... Full text Open Access Cite

Biosimilar competition: lessons from Europe

Journal Article Nature Reviews Drug Discovery · February 2014 Full text Open Access Cite

Biosimilars

Chapter · 2014 Cite

Recent Trends in Brand-Name and Generic Drug Competition

Journal Article Journal of Medical Economics · 2013 Open Access Cite

Does generic entry always increase consumer welfare?

Journal Article Food and drug law journal · January 2012 This article examines how the nature of competition between brands in a therapeutic category changes after generic entry and provide a framework for analyzing the effect of generic entry on consumer welfare that takes into account the generic free riding p ... Open Access Cite

Evolving brand-name and generic drug competition may warrant a revision of the Hatch-Waxman Act.

Journal Article Health affairs (Project Hope) · November 2011 The evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act's intended balance of incentives for cost savings and continued innovation has been achieved. Generic drug usage and chall ... Full text Open Access Cite

The Evolution of the Pharmaceutical Industry Over the Past 50 Years: A Personal Reflection

Journal Article International Journal of the Economics of Business · July 2011 Open Access Cite

Data Exclusivity for Biologics

Journal Article Nature Reviews Drug Discovery · January 2011 Open Access Cite

FDA review vouchers.

Journal Article The New England journal of medicine · February 2009 Full text Cite

The economic returns of pediatric clinical trials of antihypertensive drugs.

Journal Article Am Heart J · October 2008 BACKGROUND: Congress has authorized the United States Food and Drug Administration (FDA) to provide industry sponsors with a 6-month extension of drug marketing rights under the Pediatric Exclusivity Provision if FDA-requested pediatric drug trials are con ... Full text Link to item Cite

Do faster food and drug administration drug reviews adversely affect patient safety? An analysis of the 1992 prescription drug user fee act

Journal Article Journal of Law and Economics · May 1, 2008 Food and Drug Administration (FDA) review times have significantly declined under the user-fee regime. This situation has provoked concerns that drug safety has been adversely affected. Combining information from several comprehensive databases, we analyze ... Full text Open Access Cite

Misleading congress about drug development: Reply.

Journal Article Journal of health politics, policy and law · April 2008 The review essay by Donald Light about a Congressional Budget Office report on pharmaceutical research and development (R&D) (Light 2007) contains factual errors, leaves the reader uninformed about rebuttal responses to criticisms made in the review about ... Full text Cite

Mergers and Alliances in Pharmaceutical: Effects on Innovation and R&D Productivity

Chapter · January 1, 2008 This 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 C ... Open Access Cite

Should the patent system for new medicines be abolished?

Journal Article Clinical pharmacology and therapeutics · November 2007 Full text Open Access Cite

Impact of Economic, Regulatory and Patent Policies on Innovation in Cancer Chemoprevention

Journal Article Duke Department of Economics Working Papers · November 2007 Open Access Cite

Entry and competition in generic biologics

Journal Article Managerial and Decision Economics · June 1, 2007 Patents 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 ... Full text Open Access Cite

The cost of biopharmaceutical R&D: Is biotech different?

Journal Article Managerial and Decision Economics · June 1, 2007 The costs of developing the types of new drugs that have been pursued by traditional pharmaceutical firms have been estimated in a number of studies. However, similar analyses have not been published on the costs of developing the types of molecules on whi ... Full text Open Access Cite

Generic competition and market exclusivity periods in pharmaceuticals

Journal Article Managerial and Decision Economics · June 1, 2007 In 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 num ... Full text Open Access Cite

In reply [2]

Journal Article Journal of Clinical Oncology · June 1, 2007 Full text Cite

Competition between Generic and Branded Drugs

Chapter · April 30, 2007 The 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 ... Open Access Cite

Economic return of clinical trials performed under the pediatric exclusivity program.

Journal Article JAMA · February 7, 2007 CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric trials. The program has been pra ... Full text Open Access Link to item Cite

Economics of new oncology drug development.

Journal Article Journal of clinical oncology : official journal of the American Society of Clinical Oncology · January 2007 PurposeReview existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development.MethodsWe utilized data from the US Food and Drug Administration (FDA), company surveys, and public ... Full text Open Access Cite

The quantity and quality of worldwide new drug introductions, 1982-2003.

Journal Article Health affairs (Project Hope) · March 2006 We examined trends in the introduction of new chemical entities (NCEs) worldwide from 1982 through 2003. Although annual introductions of NCEs decreased over time, introductions of high-quality NCEs (that is, global and first-in-class NCEs) increased moder ... Full text Open Access Cite

How did the 2003 prescription drug re-importation bill pass the house?

Journal Article Economics and Politics · March 1, 2006 We examine the major interest groups in the debate over allowing the re-importation of prescription drugs by utilizing a logit model and instrumental variables. Consistent with political support approach, the evidence suggests that Representatives are maxi ... Full text Open Access Cite

Generic Competition in the U.S. Pharmaceutical Industry

Journal Article International Journal of the Economics of Business · February 2006 Open Access Cite

Developing drugs for developing countries.

Journal Article Health Aff (Millwood) · 2006 Infectious and parasitic diseases create enormous health burdens, but because most of the people suffering from these diseases are poor, little is invested in developing treatments. We propose that developers of treatments for neglected diseases receive a ... Full text Open Access Link to item Cite

Spending on postapproval drug safety.

Journal Article Health Aff (Millwood) · 2006 Withdrawals of high-profile pharmaceuticals have focused attention on post-approval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding safety efforts. Mean spending on ... Full text Open Access Link to item Cite

Extraordinary claims require extraordinary evidence

Journal Article Journal of Health Economics · September 2005 Full text Open Access Cite

Extraordinary claims require extraordinary evidence.

Journal Article Journal of health economics · September 2005 Full text Cite

Encouraging the Development of New Vaccines

Journal Article Health Affairs · 2005 Open Access Cite

Increasing R&D incentives for neglected diseases: Lessons from the Orphan Drug Act

Chapter · 2005 Distinguished 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 ... Open Access Cite

Setting the record straight in the reply by DiMasi, Hansen and Grabowski

Journal Article Journal of Health Economics · January 1, 2005 Full text Cite

R&D costs and returns by therapeutic category

Journal Article DRUG INFORMATION JOURNAL · 2004 Full text Open Access Cite

Are the Economics of Pharmaceutical R&D Changing? Productivity, Patents and Political Pressures

Journal Article PharmacoEconomics · 2004 Pharmaceutical R&D competition in the 1980s and 1990s was characterized by rising R&D expenditures, favorable returns to innovators, and the introduction of many new classes of drugs with high social benefits. However in the past three years the num ... Open Access Cite

The Ripple Effects of a Restrictive Medicaid Formulary (editorial)

Journal Article American Journal of Managed Care · October 2003 Open Access Cite

Patents and New Product Development in the Pharmaceutical and Biotechnology Industry

Journal Article The Georgetown Public Policy Review · March 2003 Open Access Cite

The price of innovation: new estimates of drug development costs.

Journal Article Journal of health economics · March 2003 The research and development costs of 68 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug development. The costs of compounds abandoned during testing ... Full text Open Access Cite

Patents, Innovation and Access to New Pharmaceuticals

Journal Article Journal of International Economic Law · February 2002 Open Access Cite

Returns on R&D for 1990s New Drug Introductions

Journal Article PharmacoEconomics · 2002 Open Access Cite

The Determinants of Pharmaceutical Research and Development Expenditures

Journal Article Journal of Evolutionary Economics · 2000 Open Access Cite

Effective Patent Life in Pharmaceuticals

Journal Article International Journal of Technology Management · 2000 Open Access Cite

The distribution of sales revenues from pharmaceutical innovation.

Journal Article PharmacoEconomics · January 2000 ObjectiveThis report updates our earlier work on the returns to pharmaceutical research and development (R&D) in the US (1980 to 1984), which showed that the returns distributions are highly skewed. It evaluates a more recent cohort of new drug in ... Full text Open Access Cite

Effective patent life in pharmaceuticals

Journal Article International Journal of Technology Management · January 1, 2000 Effective patent life is lost in pharmaceuticals because of the lengthy time periods required for clinical trials and regulatory approval. A 1984 US law restores some of this lost patent time, while also facilitating generic competition when patents expire ... Full text Cite

Conclusions and implications

Journal Article Social Science and Medicine · January 1, 1997 Full text Cite

R&D Costs, Innovative Output and Firm Size in the Pharmaceutical Industry

Journal Article International Journal of the Economics of Business · 1995 Open Access Cite

Returns to R&D on new drug introductions in the 1980s.

Journal Article Journal of health economics · December 1994 This study finds that the mean IRR for 1980-84 U.S. new drug introductions is 11.1%, and the mean NPV is 22 million (1990 dollars). The distribution of returns is highly skewed. The results are robust to plausible changes in the baseline assumptions. Our w ... Full text Open Access Cite

Health Reform and Pharmaceutical Innovation

Journal Article Seton Hall Law Review · 1994 Open Access Cite

Innovation and Structural Change in Pharmaceuticals and Biotechnology

Journal Article Industrial and Corporate Change · 1994 Open Access Cite

The Costs and Returns to Pharmaceutical Research and Development

Journal Article Revista Internazionale di Scienze sociali (International Social Studies Review) · September 1992 Open Access Cite

The effect of Medicaid formularies on the availability of new drugs.

Journal Article PharmacoEconomics · January 1992 This study expands our previous work on the availability of new drug introductions to poor patients in states in the USA with restrictive Medicaid formularies. In particular, it focuses on the experience of 9 states over the period 1979 to 1985. In these ... Full text Cite

Cost of innovation in the pharmaceutical industry.

Journal Article Journal of health economics · July 1991 The 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 aband ... Full text Open Access Cite

Product Liability in Pharmaceuticals: Comments on Chapters Eight and Nine

Chapter · 1991 With an ever-increasing number of liability lawsuits, are corporations electing to play it safe rather than risk the uncertainties accompanying innovation? In The Liability Maze experts address the issues surrounding safety and innovation and present the m ... Open Access Cite

A New Look at the Returns and Risks to Pharmaceutical R & D

Journal Article Management Science · July 1990 Open Access Cite

Price and Availability Tradeoffs of Automobile Insurance Regulation

Journal Article Journal of Risk and Insurance · June 1989 Open Access Cite

AN ANALYSIS OF UNITED-STATES INTERNATIONAL COMPETITIVENESS IN PHARMACEUTICALS

Journal Article MANAGERIAL AND DECISION ECONOMICS · March 1, 1989 Open Access Link to item Cite

Medicaid Patients' Access to New Drugs

Journal Article Health Affairs · December 1988 Open Access Cite

Longer Patents for Lower Imitation Barriers: The 1984 Drug Act

Journal Article The American Economic Review · May 1986 Open Access Cite

Issues of drug development: orphan drugs.

Journal Article Science (New York, N.Y.) · May 1985 Full text Cite

Organizational Capital and the Choice between Specialization and Diversification

Journal Article Managerial and Decision Economics · March 1985 Cite

The Impact of Patent and Regulatory Policies on Drug Innovation

Journal Article Medical Marketing & Media · October 1983 Cite

Public Policy and Pharmaceutical Innovation

Journal Article Health Care Financing Review · September 1982 Cite

Auto Safety Regulation: An Analysis of Market Failure

Journal Article The Bell Journal of Economics · March 1981 Cite

IMPACT OF REGULATION ON INNOVATION

Journal Article FOOD AND DRUG LAW JOURNAL · January 1, 1979 Link to item Cite

SUBSTITUTION LAWS AND INNOVATION IN THE PHARMACEUTICAL-INDUSTRY

Journal Article LAW AND CONTEMPORARY PROBLEMS · January 1, 1979 Open Access Link to item Cite

The Effects of Advertising on IntraIndustry Shifts on Demand

Journal Article Occasional Papers of the National Bureau of Economic Research, Explorations in Economic Research · October 1978 Cite

Consumer product safety regulation

Journal Article American Economic Review · January 1, 1978 While it is still too early to evaluate con- clusively the recent wave of consumer product safety regulation, the evidence thus far indicates that serious resource mis- allocation is taking place and is likely to continue. The regulators of product safety ... Cite

EFFECTS OF SUBSTITUTION LAWS ON INNOVATION

Journal Article DRUG THERAPY · January 1, 1978 Link to item Cite

CONSUMER-PROTECTION REGULATION IN ETHICAL DRUGS

Journal Article AMERICAN ECONOMIC REVIEW · January 1, 1977 Open Access Link to item Cite

Life-Cycle Effects on Corporate Returns on Retentions

Journal Article The Review of Economics and Statistics · November 1975 Full text Cite

Rivalry in Research and Development: An Empirical Study

Journal Article Journal of Industrial Economics · July 1973 Cite

Determinants and Distributional Aspects of Enrollment in U.S. Higher Education

Journal Article Journal of Human Resources · December 1972 Open Access Cite

Managerial and Stockholder Welfare Models of Firm Expenditures

Journal Article Review of Economics and Statistics · February 1972 Open Access Cite

Imitative Advertising in the Cigarette Industry

Journal Article The Journal of American and Foreign Antitrust and Trade Regulations · July 1971 Cite

Non-Price Competition in the Cigarette Industry: A Coment

Journal Article Antitrust Bulletin · December 1970 Cite

Industrial Organization: The Role and Contribution of Econometrics

Journal Article American Economic Review · May 1970 Open Access Cite

Demand Shifting, Optimal Firm Growth, and Rule-of-Thumb Decision Making

Journal Article Quarterly Journal of Econoics · May 1970 Open Access Cite